title: Psychoeducation versus treatment as usual in diabetic patients with subthreshold depression: preliminary results of a randomized controlled trial The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews The Impact of Symptomatology on Response to a Health Promoting Intervention among Older Adults with Schizophrenia Clinical complexity and the effectiveness of an intervention for depressed diabetes patients Integrating Type 2 Diabetes Mellitus and Depression Treatment Among African Americans The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Improving the physical health of long-term psychiatric inpatients Web-Based Depression Treatment for Type 1 and Type 2 Diabetic Patients Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: design of a cluster-randomized controlled trial Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus A Randomized Controlled Trial of Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Patients With Uncontrolled Type 2 Diabetes A checklist designed to aid consistency and reproducibility of GRADE assessments: development and pilot validation Is a Severe Clinical Profile an Effect Modifier in a Web-Based Depression Treatment for Adults With Type 1 or Type 2 Diabetes? Secondary Analyses From a Randomized Controlled Trial Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support. Influence of a Community Health Worker Intervention on Mental Health Outcomes among Low-Income Latino and African American Adults with Type 2 Diabetes Depression and Diabetes among Low-Income Hispanics: Design Elements of a Socio-Culturally Adapted Collaborative Care Model Randomized Controlled Trial Cost-effectiveness of systematic depression treatment among people with diabetes mellitus. Development and reach of a web-based cognitive behavioural therapy programme to reduce symptoms of depression and diabetes-specific distress. The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial. Pharmacist-Led Group Medical Appointments for the Management of Type 2 Diabetes with Comorbid Depression in Older Adults Effects of a Multifaceted Psychiatric Intervention Targeted for the Complex Medically Ill: A Randomized Controlled Trial Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Treating depression in diabetes patients: does a nurse-administered minimal psychological intervention affect diabetes-specific quality of life and glycaemic control? A randomized controlled trial. Cost-effectiveness and net benefit of enhanced treatment of depression for older adults with diabetes and depression. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder. A lifestyle intervention for older schizophrenia patients with diabetes mellitus: A randomized controlled trial Predicting response to cognitive behavior therapy of depression in type 2 diabetes. Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial Integrated Management of Type 2 Diabetes Mellitus and Depression Treatment to Improve Medication Adherence: A Randomized Controlled Trial
abstract: Background Research on the effects of treating sub-threshold depression in persons with diabetes is scarce in spite of the findings indicating that this condition is highly prevalent in the diabetic population and may increase the risk of developing a subsequent major depression . This study was aim ed at exploring the effects of a psycho-educational intervention on depression- and diabetes-related outcomes in patients with mild to moderate depressive symptoms . Methods A r and omized controlled study design with a one-year follow-up was used . Fifty patients with mild to moderate depressive symptoms ( 74 % female , aged 57 ± 9 yrs , diabetes duration of 10 ± 8 yrs , BMI 31 ± 6 kg/m2 , HbA1C 7.7 % ± 1.4 , 53 % insulin treated ) were r and omly assigned to either an intervention or a control group . The intervention group underwent four psycho-educational sessions aim ed at enabling self-management of depressive symptoms . The control group was informed about the screening results and depression treatment options while continuing diabetes treatment as usual . Both groups were contacted by phone in 2–3-month intervals , and re-assessed for depression after 6 and 12 months . Changes in depressive symptoms and glycaemic control were considered primary outcomes . Mann-Whitney U test and Friedman ANOVA were used to compare between- and within-group indicators at 6- and 12-month follow-ups . Results Both the intervention and the control group reported a significant decrease in depressive symptoms as measured by the CES-D scale ( Friedman ANOVA χ2 = 10.8 p = .004 and χ2 = 7.3 p = 0.03 , respectively ) . The 6-month and 1-year indicators of glycaemic control as compared to baseline HbA1C values were also improved in both groups ( χ2 = 11.6 p = 0.003 and χ2 = 17.1 p = 0.0002 , respectively ) . Between-group differences in depressive symptoms and HbA1C values were not statistically significant either at 6- or at 12-month follow-up ( all p > 0.05 ) . Conclusion Psycho-educational treatment appears to be beneficial in diabetic patients with mild to moderate depressive symptoms  , but its effects are comparable with the non-specific support given to the subjects in the control group . Trial registration Current Controlled Trials IS RCT Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Purpose To explore the relationship between the symptoms of schizophrenia experienced by older persons diagnosed with schizophrenia and type 2 diabetes mellitus and their response to a health promoting intervention . Methods Secondary data analysis of data obtained from a lifestyle intervention program that recruited participants over age 40 with schizophrenia or schizoaffective disorder and type 2 diabetes mellitus from board- and -care facilities and day treatment programs . Participants had been r and omly assigned to a 24-week diabetes awareness and rehabilitation training ( DART ; n = 32 ) or a usual care plus information ( UCI ; n = 32 ) comparison group . Baseline and 6-month ( intervention completion ) assessment s included a diabetes knowledge test ( DKT ) , diabetes self-efficacy measured by the diabetes empowerment scale ( DES ) , and symptomatology defined by the Positive and Negative Syndrome Scale ( PANSS ) . Simple linear regression models in 3 steps were used to analyze the data . Results A significant condition by symptom interaction was found for DKT . The difference between change in knowledge for DART and UCI groups depended on the prevalence and severity of the total , negative , and general symptoms . There was no significant condition by positive symptom interaction for DKT . A significant main effect was found between total , negative , positive , and general symptoms in the total sample for improvement in DES scores . Higher prevalence and severity of symptoms was negatively associated with improvement in DES scores . Conclusion Research ers need to consider the impact of schizophrenia symptoms in response to health promoting interventions Objectives : In a trial completed in 2010 , US patients with diabetes and depression were r and omized to usual care or telephone cognitive behavioural therapy that emphasized physical activity . Twelve-month intervention effects were observed for blood pressure , depression , and pedometer-measured step-counts . This study examined variation in intervention effects across patient subgroups defined by a measure of clinical complexity . Methods : Three groups of patients were identified at baseline using the Vector Model of Complexity that recognizes socioeconomic , biological , behavioural , and other determinants of treatment response . Complexity-by-intervention interactions were examined using regression models . Results : Intervention effects for blood pressure , depression , and step-counts differed across complexity levels ( each p < 0.01 ) . Effects on Beck Depression Inventory scores were greater in the low-complexity group ( −8.8 ) than in the medium- ( −3.2 ) or high-complexity groups ( −2.7 ) . Physical activity effects also were greatest in the low-complexity group ( increase of 1498 steps per day ) . In contrast , systolic blood pressure effects were greater among intervention patients with high complexity ( −8.5 mmHg ) . Conclusions : This intervention had varying impacts on physical and mental health depending on patients ' clinical complexity . Physical activity and depressive symptom gains may be more likely among less complex patients , although more complex patients may achieve cardiovascular benefits through decreased blood pressures Purpose The purpose of this study was to examine whether integrating depression treatment into care for type 2 diabetes mellitus among older African Americans improved medication adherence , glycemic control , and depression outcomes . Methods Older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice in west Philadelphia were r and omly assigned to an integrated care intervention or usual care .  Adherence was assessed at baseline , 2 , 4 , and 6 weeks using the  Medication Event Monitoring System to assess adherence . Outcomes assessed at baseline and 12 weeks included st and ard laboratory tests to measure glycemic control and the Center for Epidemiologic Studies Depression Scale ( CES-D ) to assess depression . Results In all , 58 participants aged 50 to 80 years participated . The proportion of participants who had 80 % or greater adherence to an oral hypoglycemic ( intervention 62.1 % vs usual care 24.1 % ) and an antidepressant ( intervention 62.1 % vs usual care 10.3 % ) was greater in the intervention group in comparison with the usual care group at 6 weeks . Participants in the integrated care intervention had lower levels of glycosylated hemoglobin ( intervention 6.7 % vs usual care 7.9 % ) and fewer depressive symptoms ( CES-D mean scores : intervention 9.6 vs usual care 16.6 ) compared with participants in the usual care group at 12 weeks . Conclusion A pilot r and omized controlled trial integrating type 2 diabetes mellitus treatment and depression was successful in improving outcomes among older African Americans . Integrated interventions may be more feasible and effective in real-world practice s with competing dem and s for limited re sources Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background : Patients with psychiatric illness have increased somatic morbidity and increased mortality . Knowledge of how to integrate the prevention and care of somatic illness into the treatment of psychiatric patients is required . The aims of this study were to investigate whether an intervention programme to improve physical health is effective . Methods : An extension of the European Network for Promoting the Health of Residents in Psychiatric and Social Care Institutions ( HELPS ) project further developed as a 12-month controlled cluster-r and omized intervention study in the Danish centre . Waist circumference was a proxy of unhealthy body fat in view of the increased risk of cardiovascular diseases and type 2 diabetes . Results :  Waist circumference was 108 cm for men and 108 cm for women . Controlled for cluster r and omization , sex , age , and body fat , the intervention group showed a small , but not significant , reduction in waist circumference , while participants in the control group showed a significant increase in waist circumference . Conclusions : The intervention had a positive effect on the physical health of the patients measured by a reduction in the increase of waist circumference OBJECTIVE Comorbid depression is common in patients with type 1 and type 2 diabetes , adversely affecting quality of life , diabetes outcomes , and mortality . Depression can be effectively treated with cognitive behavior therapy ( CBT ) . The Internet is a new and attractive method for delivering CBT intervention on a large scale at relatively low costs . This study evaluated the effectiveness of Web-based CBT for depression treatment in adults with type 1 or type 2 diabetes , with minimal guidance . RESEARCH DESIGN AND METHODS A r and omized controlled trial was conducted in the Netherl and s in 255 adult diabetic patients with elevated depressive symptoms . Primary outcomes were depressive symptoms . Secondary outcomes were diabetes-specific emotional distress and glycemic control . Assessment s were at baseline , after treatment , and at the 1-month follow-up . RESULTS The Web-based CBT was effective in reducing depressive symptoms by intention-to-treat analyses ( P = 0.04 , d = 0.29 ; clinical improvement 41 % vs. 24 % P < 0.001 ) and by per- protocol analyses ( P < 0.001 , d = 0.70 ; clinical improvement , 56 % vs. 24 % P < 0.001 ) . The intervention reduced diabetes-specific emotional distress ( P = 0.03 ) but had no beneficial effect on glycemic control ( P > 0.05 ) . CONCLUSIONS Web-based CBT depression treatment is effective in reducing depressive symptoms in adults with type 1 and type 2 diabetes . In addition , the intervention reduces diabetes-specific emotional distress in depressed patients Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Background Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and /or coronary heart disease and this negatively impacts quality of life . Subthreshold depression is the most important risk factor for the development of major depression . Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care , there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder . Nurse led stepped-care is a promising way to accomplish this . The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and /or coronary heart disease in primary care who also have subthreshold depressive symptoms . Methods / design An economic evaluation will be conducted alongside a cluster-r and omized controlled trial in approximately thirty general practice s in the Netherl and s. R and omization takes place at the level of participating practice nurses . We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual .  The stepped-care program consists of four sequential but flexible treatment steps : 1 ) watchful waiting , 2 ) guided self-help treatment , 3 ) problem solving treatment and 4 ) referral to the general practitioner . The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview . Secondary outcomes include severity of depressive symptoms , quality of life , anxiety and physical outcomes . Costs will be measured from a societal perspective and include health care utilization , medication and lost productivity costs . Measurements will be performed at baseline and 3 , 6 , 9 and 12 months . Discussion The intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and /or coronary heart disease and subthreshold depression , with subsequent beneficial effects on quality of life , clinical outcomes and health care costs . When proven cost-effective , the program provides a viable treatment option in the Dutch primary care system . Trial registration Dutch Trial Register Background Depression is common in diabetes and associated with hyperglycemia , diabetes related complications and mortality . No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control . Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy ( CBT ) compared to sertraline ( SER ) in adults with depression and poorly controlled diabetes . Methods / Design This study is a multi-center parallel arm r and omized controlled trial currently in its data analysis phase . We included 251 patients in 70 secondary care centers across Germany . Key inclusion criteria were : type 1 or 2 diabetes , major depression ( diagnosed with the Structured Clinical Interview for DSM-IV , SCID ) and hemoglobin A1C > 7.5 % despite current insulin therapy . During the initial phase , patients received either 50–200 mg/d sertraline or 10 CBT sessions aim ing at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes . Both groups received diabetes treatment as usual . After 12 weeks of this initial open-label therapy , only the treatment-responders ( 50 % depression symptoms reduction , Hamilton Depression Rating Scale , 17-item version [ HAMD ] ) were included in the subsequent one year study phase and represented the primary analysis population . CBT-responders received no further treatment , while SER-responders obtained a continuous , flexible-dose SER regimen as relapse prevention . Adherence to treatment was analyzed using therapeutic drug monitoring ( measurement of sertraline and N-desmethylsertraline concentrations in blood serum ) and by counting the numbers of CBT sessions received . Outcome assessment s were conducted by trained psychologists blinded to group assignment . Group differences in HbA1c ( primary outcome ) and depression ( HAMD , secondary outcome ) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values . As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase . Discussion The DAD study is the first r and omized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression . The study is investigator initiated and was supported by the ‘ Förderprogramm Klinische Studien ( Clinical Trials ) ’ and the ‘ Competence Network for Diabetes mellitus ’ funded by the Federal Ministry of Education and Research ( FKZ 01KG0505).Trial registration Current controlled trials IS RCT N89333241 OBJECTIVE To test cognitive behavioral therapy for  adherence and depression ( CBT-AD ) in type 2 diabetes . We hypothesized that CBT-AD would improve adherence ; depression ; and , secondarily , hemoglobin A1c ( A1C ) . RESEARCH DESIGN AND METHODS Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual ( ETAU ) , including medication adherence , self-monitoring of blood glucose ( SMBG ) , and lifestyle counseling ; a provider letter documented psychiatric diagnoses . Those r and omized to the intervention arm also received 9–11 sessions of CBT-AD . RESULTS Immediately after acute treatment ( 4 months ) , adjusting for baseline , CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap ( 95 % CI −31.14 to −10.22 , P = 0.000 ) ; 30.2 percentage points greater SMBG adherence through glucometer downloads ( 95 % CI −42.95 to −17.37 , P = 0.000 ) ; 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale ( 95 % CI 2.33–10.56 , P = 0.002 ) ; 0.74 points lower on the Clinical Global Impression ( 95 % CI 0.16–1.32 , P = 0.01 ) ; and 0.72 units lower A1C ( 95 % CI 0.29–1.15 , P = 0.001 ) relative to ETAU . Analyses of 4- , 8- , and 12-month follow-up time points indicated that CBT-AD maintained 16.3 percentage points higher medication adherence ( 95 % CI −26.1 to −6.5 , P = 0.001 ) ; 22.3 percentage points greater SMBG adherence ( 95 % CI −36.1 to −8.6 , P = 0.002 ) ; and 0.63 units lower A1C ( 95 % CI 0.06–1.2 , P = 0.03 ) after acute treatment ended . For depression , there was some evidence of continued improvement posttreatment , but no between-group differences . CONCLUSIONS CBT-AD is an effective intervention for adherence , depression , and glycemic control , with enduring and clinical ly meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently Background Depression and diabetes are two highly prevalent and co-occurring health problems . Web-based , diabetes-specific cognitive behavioral therapy ( CBT ) depression treatment is effective in diabetes patients , and has the potential to be cost effective and to have large reach . A remaining question is whether the effectiveness differs between patients with seriously impaired mental health and patients with less severe mental health problems . Objective To test whether the effectiveness of an eight-lesson Web-based , diabetes-specific CBT for depression , with minimal therapist support , differs in patients with or without diagnosed major depressive disorder ( MDD ) , diagnosed anxiety disorder , or elevated diabetes-specific emotional distress ( DM-distress ) . Methods We used data of 255 patients with diabetes with elevated depression scores , who were recruited via an open access website for participation in a r and omized controlled trial , conducted in 2008–2009 , comparing a diabetes-specific , Web-based , therapist-supported CBT with a 12-week waiting-list control group . We performed secondary analyses on these data to study whether MDD or anxiety disorder ( measured using a telephone-administered diagnostic interview ) and elevated DM-distress ( online self-reported ) are effect modifiers in the treatment of depressive symptoms ( online self-reported ) with Web-based diabetes-specific CBT . Results MDD , anxiety disorder , and elevated DM-distress were not significant effect modifiers in the treatment of self-assessed depressive symptoms with Web-based diabetes-specific CBT . Conclusions This Web-based diabetes-specific CBT depression treatment is suitable for use in patients with severe mental health problems and those with a less severe clinical profile . Clinical Trial International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 24874457 ; http://www.controlled-trials.com/IS RCT N24874457 ( Archived by WebCite at http://www.webcitation.org/63hwdviYr BACKGROUND & OBJECTIVES Community health workers ( CHWs ) may be an important mechanism to provide diabetes self-management to disadvantaged population s. We describe the design and baseline results of a trial evaluating a home-based CHW intervention . METHODS & RESEARCH DESIGN Peer Support for Achieving Independence in Diabetes ( Peer-AID ) is a r and omized , controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care . The study recruited participants from 3 health systems .  Change in A1c measured at 12 months is the primary outcome . Changes in blood pressure , lipids , health care utilization , health-related quality of life , self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes . RESULTS A total of 1438 patients were identified by a medical record review as potentially eligible , 445 patients were screened by telephone for eligibility and 287 were r and omized . Groups were comparable at baseline on socio-demographic and clinical characteristics . All participants were low-income and were from diverse racial and ethnic background s. The mean A1c was 8.9 % , mean BMI was above the obese range , and non-adherence to diabetes medications was high . The cohort had high rates of co-morbid disease and low self-reported health status . Although one-third reported no health insurance , the mean number of visits to a physician in the past year was 5.7 . Trial results are pending . CONCLUSIONS Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program . If effective , replication of the Peer-AID intervention in community based setting s could contribute to improved control of diabetes in vulnerable population This study investigated the influence of a community health worker ( CHW ) diabetes lifestyle intervention on mental health outcomes . Our study was guided by the principles of community-based participatory research . Data were collected from 164 African American ( N = 94 ) and Hispanic adults ( N = 70 ) participating in a r and omized , 6-month delayed intervention group design for improving glycemic control . The intervention time periods were baseline to 6 months for the treatment group and 6–12 months for the delayed group . Linear mixed models were used to conduct longitudinal analyses of the Problem Areas in Diabetes ( PAID ) and Patient Health Question naire ( PHQ ) scales . In the model adjusted for demographics , the PAID dropped significantly from pre-intervention to post-intervention within both the treatment and delayed groups ( p < 0.05 ) with an average intervention effect of −6.4 ( p < 0.01 ) . The PAID dropped even further within the immediate group from 6 to 12 months . Although the PHQ did not change significantly , the PHQ-2 had an average intervention effect of −0.3 ( p < 0.05 ) in the model adjusted for demographics . This study contributes to an underst and ing of how a CHW-led diabetes intervention can result in positive mental health outcomes for Latinos and African Americans with Type 2 diabetes . It also highlights the importance of further exploring what factors may contribute to racial/ethnic variation in mental health outcomes for African Americans and Latinos with diabetes and the role CHWs can play Objective : This article describes design elements of the Multifaceted Depression and Diabetes Program ( MDDP ) r and omized clinical trial . The MDDP trial hypothesizes that a socioculturally adapted collaborative care depression management intervention will reduce depressive symptoms and improve patient adherence to diabetes self-care regimens , glycemic control , and quality -of-life . In addition , baseline data of 387 low-income , 96 % Hispanic , enrolled patients with major depression and diabetes are examined to identify study population characteristics consistent with trial design adaptations . Methods : The  PHQ-9 depression scale  was used to identify patients meeting criteria for major depressive disorder ( 1 cardinal depression symptom + a PHQ-9 score of > 10 ) from two community safety net clinics . Design elements included sociocultural adaptations in recruitment and efforts to reduce attrition and collaborative depression care management . Results : Of 1,803 diabetes patients screened , 30.2 % met criteria for major depressive disorder . Of 387 patients enrolled in the clinical trial , 98 % had Type 2 diabetes , and 83 % had glycated hemoglobin ( HbA1c ) levels ≥ 7 % . Study recruitment rates and baseline data analyses identified socioeconomic and clinical factors that support trial design and intervention adaptations . Depression severity was significantly associated with diabetes complications , medical comorbidity , greater anxiety , dysthymia , financial worries , social stress , and poorer quality -of-life . Conclusion : Low-income Hispanic patients with diabetes experience high prevalence of depressive disorder and depression severity is associated with socioeconomic stressors and clinical severity . Improving depression care management among Hispanic patients in public sector clinics should include intervention components that address self-care of diabetes and socioeconomic stressors CONTEXT Depression co-occurring with diabetes mellitus is associated with higher health services costs , suggesting that more effective depression treatment might reduce use of other medical services . OBJECTIVE To evaluate the incremental cost and cost-effectiveness of a systematic depression treatment program among out patients with diabetes . DESIGN R and omized controlled trial comparing systematic depression treatment program with care as usual . SETTING Primary care clinics of group-model prepaid health plan . PATIENTS A 2-stage screening process identified 329 adults with diabetes and current depressive disorder . INTERVENTION Specialized nurses delivered a 12-month , stepped-care depression treatment program beginning with either problem-solving treatment psychotherapy or a structured antidepressant pharmacotherapy program . Subsequent treatment ( combining psychotherapy and medication , adjustments to medication , and specialty referral ) was adjusted according to clinical response . MAIN OUTCOME MEASURES Depressive symptoms were assessed by blinded telephone assessment s at 3 , 6 , 12 , and 24 months . Health service costs were assessed using health plan accounting records . RESULTS Over 24 months , patients assigned to the intervention accumulated a mean of 61 additional days free of depression ( 95 % confidence interval [ CI ] , 11 to 82 days ) and had outpatient health services costs that averaged $ 314 less ( 95 % CI , $ 1007 less to $ 379 more ) compared with patients continuing in usual care . When an additional day free of depression is valued at $ 10 , the net economic benefit of the intervention is $ 952 per patient treated ( 95 % CI , $ 244 to $ 1660 ) . CONCLUSIONS For adults with diabetes , systematic depression treatment significantly increases time free of depression and appears to have significant economic benefits from the health plan perspective . Depression screening and systematic depression treatment should become routine components of diabetes care OBJECTIVES There is an urgent need for more effective and efficient depression treatments in diabetes . We developed a diabetes-specific version of the Dutch web-based ' Coping with Depression ' ( CWD ) course . Here , we report on the development , reach , patients ' reasons for choosing our intervention and their characteristics . METHODS The CWD programme was amended for use in diabetes patients with co-morbid depression . Data were collected using a telephone interview , self-report question naires , and medical records . RESULTS Adding diabetes-specific topics to an effective web-based depression programme result ed in an 8-lesson intervention ( " www.diabetergestemd.nl " ) , with minimal guidance by coaches . In the framework of a r and omised trial , the intervention attracted serious interest of 540 patients . After screening , 255 depressed diabetes patients were enrolled . Less than half had a history of depression treatment ; 80 % reported the diabetes-specific approach to be an important reason for signing up . CONCLUSION We successfully developed a diabetes-specific version of the web-based CWD course , which attracted a large group of patients . Our results affirm the importance of addressing diabetes-specific issues in the context of depression treatment . PRACTICE IMPLICATION S Our intervention could be implemented on a large scale at low costs , and may serve as a model on how to develop other illness-specific online self-help interventions OBJECTIVES The STRIDE study assessed whether a lifestyle intervention , tailored for individuals with serious mental illnesses , reduced weight and diabetes risk . The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism . METHOD The study design was a multisite , parallel two-arm r and omized controlled trial in community setting s and an integrated health plan . Participants who met inclusion criteria were ≥18 years old , were taking antipsychotic agents for ≥30 days , and had a body mass index ≥27 . Exclusions were significant cognitive impairment , pregnancy/breastfeeding , recent psychiatric hospitalization , bariatric surgery , cancer , heart attack , or stroke . The intervention emphasized moderate caloric reduction , the DASH ( Dietary Approaches to Stop Hypertension ) diet , and physical activity . Blinded staff collected data at baseline , 6 months , and 12 months . RESULTS Participants ( men , N=56 ; women , N=144 ; mean age=47.2 years [ SD=10.6 ] ) were r and omly assigned to usual care ( N=96 ) or a 6-month weekly group intervention plus six monthly maintenance sessions ( N=104 ) . A total of 181 participants ( 90.5 % ) completed 6-month assessment s , and 170 ( 85 % ) completed 12-month assessment s , without differential attrition . Participants attended 14.5 of 24 sessions over 6 months . Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months ( 95 % CI=-6.96 kg to -1.78 kg ) and 2.6 kg more than control participants from baseline to 12 months ( 95 % CI=-5.14 kg to -0.07 kg ) . At 12 months , fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study -related ; medical hospitalizations were reduced in the intervention group ( 6.7 % ) compared with the control group ( 18.8 % ) . CONCLUSIONS Individuals taking antipsychotic medications  can lose weight and improve fasting glucose levels . Increasing reach of the intervention is an important future step Background : : Depression is associated with poor glycemic control , increased number of microvascular and macrovascular complications , functional impairment , mortality , and 4.5 times higher total health care costs in patients with diabetes .  Shared medical appointments ( SMAs ) may be an effective method to attain national guideline recommendations for glycemic control in diabetes for patients with depression through peer support , counseling , problem solving , and improved access to care . Objective : To test the efficacy as assessed by attainment of a hemoglobin A1c ( A1C ) < 7 % of pharmacistted group SMA visits , Veterans Affairs Multidisciplinary Education in Diabetes and Intervention for Cardiac Risk Reduction in Depression ( VA-MEDIC-D ) , in patients with type 2 diabetes mellitus . Methods : This was a r and omized controlled trial of VA-MEDIC-D added to st and ard care versus st and ard care alone in depressed patients with diabetes with A1C > 6.5 % .  VA-MEDIC-D consisted of 4 once-weekly , 2-hour sessions followed by 5 monthly 90-minute group sessions . Each SMA session consisted of multidisciplinary education and pharmacist-led behavioral and pharmacologic interventions for diabetes , lipids , smoking , and blood pressure . No pharmacologic interventions for depression were provided . The change in the proportion of participants who achieved an A1C < 7 % at 6 months was compared . Results : Compared to st and ard care ( n = 44 ) , a lower proportion of patients in VA-MEDIC-D ( n = 44 ) had systolic blood pressure ( SBP ) < 130 mm Hg at baseline , but were similar in other cardiovascular risk factors and psychiatric comorbidity . The change in the proportion of participants achieving an A1C < 7 % was greater in the VA-MEDIC-D arm than in the st and ard care arm ( 29.6 % vs 11.9 % ) , with odds ratio 3.6 ( 95 % CI 1.1 to 12.3 ) . VA-MEDIC-D participants also achieved significant reductions in SBP , low-density lipoprotein cholesterol , and non – high-density lipoprotein ( HDL ) cholesterol from baseline , whereas significant reductions were attained only in non – HDL cholesterol with st and ard care . There was no significant change in depressive symptoms for either arm . Conclusions : Pharmacist-led group SMA visits are efficacious in attainment of glycemic control in patients with diabetes and depression without change in depression symptoms Background : This study evaluated a multifaceted psychiatric intervention targeted at the complex medically ill identified by means of the INTERMED , an instrument to assess case complexity . Methods : Of 885 rheumatology in patients and diabetes out patients who were assessed for eligibility , 247 were identified as complex ( INTERMED score > 20 ) and r and omized to the intervention ( n = 125 , 84 rheumatology and 41 diabetes patients ) or care as usual ( n = 122 , 78 rheumatology and 44 diabetes patients ) . For the majority of the cases the multifaceted intervention consisted of an intervention conducted by a psychiatric liaison nurse and /or of referral to a liaison psychiatrist , followed by advice to the treating physician or organization of a multidisciplinary case conference . Baseline and follow-up at months 3 , 6 , 9 and 12 measured prevalence of major depression ( Mini-International Neuropsychiatric Interview ) , depressive symptoms ( Center for Epidemiological Studies Depression Rating Scale ) , physical and mental health ( SF-36 ) , quality of life ( EuroQol ) , health care utilization and HbA1c levels ( diabetic patients ) . Results : Prevalence of major depression was reduced from 61 % ( T0 ) to 28 % ( T4 ) in the intervention group and remained stable in care as usual ( 57 % at T0 to 50 % at T4 ) . Compared to care as usual , significant improvement over time was observed in the intervention group with regard to depressive symptoms ( F = 11.9 ; p = 0.001 ) , perception of physical ( F = 5.7 ; p = 0.018 ) and mental health ( F = 3.9 ; p = 0.047 ) and quality of life ( F = 21.8 ; p < 0.001 ) . Effects tended to be stronger in diabetes patients , in patients with baseline major depression and in patients with moderate INTERMED scores . Finally , hospital admissions occurred less often in the intervention group , reaching statistical significance for the period between 6 and 9 months of follow-up ( p = 0.02 ) . Conclusions : The results suggest that a psychiatric intervention targeted for complex medical patients can improve health outcomes OBJECTIVE The ability to accurately identify articles about therapy in large bibliographic data bases such as EMBASE is important for research ers and clinicians . Our study aim ed to develop optimal search strategies for detecting sound treatment studies in EMBASE in the year 2000 . METHODS H and search es of journals were compared with retrievals from EMBASE for c and i date search strategies . Six trained research assistants review ed fifty-five journals indexed in EMBASE and rated articles using purpose and quality indicators . C and i date search strategies were developed for identifying treatment articles and then tested , and the retrievals were compared with the h and - search data . The operating characteristics of the strategies were calculated . RESULTS Three thous and eight hundred fifty articles were original studies on treatment , of which 1,256 ( 32.6 % ) were method ologically sound . Combining search terms revealed a top performing strategy ( r and om:.tw . OR clinical trial:.mp . OR exp health care quality ) with sensitivity of 98.9 % and specificity of 72.0 % . Maximizing specificity , a top performing strategy ( double-blind:.mp . OR placebo:.tw . OR blind : .tw . ) achieved a value over 96.0 % , but with compromised sensitivity at 51.7 % . A 3-term strategy achieved the best optimization of sensitivity and specificity ( r and om:.tw . OR placebo:.mp . OR double-blind:.tw . ) , with both these values over 92.0 % . CONCLUSION Search strategies can achieve high performance for retrieving sound treatment studies in EMBASE BACKGROUND There is a high prevalence of depression in patients with diabetes mellitus . Depression has been shown to be associated with poor self-management ( adherence to diet , exercise , checking blood glucose levels ) and high hemoglobin A1c ( HbA1c ) levels in patients with diabetes . OBJECTIVE To determine whether enhancing quality of care for depression improves both depression and diabetes outcomes in patients with depression and diabetes . DESIGN R and omized controlled trial with recruitment from March 1 , 2001 , to May 31 , 2002 . SETTING Nine primary care clinics from a large health maintenance organization . PARTICIPANTS A total of 329 patients with diabetes mellitus and comorbid major depression and /or dysthymia . Intervention Patients were r and omly assigned to the Pathways case management intervention ( n = 164 ) or usual care ( n = 165 ) . The intervention provided enhanced education and support of antidepressant medication treatment prescribed by the primary care physician or problem-solving therapy delivered in primary care . MAIN OUTCOME MEASURES Independent blinded assessment s at baseline and 3 , 6 , and 12 months of depression ( Hopkins Symptom Checklist 90 ) , global improvement , and satisfaction with care . Automated clinical data were used to evaluate adherence to antidepressant regimens , percentage receiving specialty mental health visits , and HbA1c levels . RESULTS When compared with usual care patients , intervention patients showed greater improvement in adequacy of dosage of antidepressant medication treatment in the first 6-month period ( odds ratio [ OR ] , 4.15 ; 95 % confidence interval [ CI ] , 2.28 - 7.55 ) and the second 6-month period ( OR , 2.90 ; 95 % CI , 1.69 - 4.98 ) , less depression severity over time ( z = 2.84 , P = .004 ) , a higher rating of patient-rated global improvement at 6 months ( intervention 69.4 % vs usual care 39.3 % ; OR , 3.50 ; 95 % CI , 2.16 - 5.68 ) and 12 months ( intervention 71.9 % vs usual care 42.3 % ; OR , 3.50 ; 95 % CI , 2.14 - 5.72 ) , and higher satisfaction with care at 6 months ( OR , 2.01 ; 95 % CI , 1.18 - 3.43 ) and 12 months ( OR , 2.88 ; 95 % CI , 1.67 - 4.97 ) . Although depressive outcomes were improved , no differences in HbA1c outcomes were observed . CONCLUSION The Pathways collaborative care model improved depression care and outcomes in patients with comorbid major depression and /or dysthymia and diabetes mellitus , but improved depression care alone did not result in improved glycemic control AIMS The aim of this study was to examine whether a nurse-administered minimal psychological intervention for depressive symptoms improves diabetes-specific quality of life and glycaemic control in older persons with diabetes . BACKGROUND Depression is common among persons with diabetes and may have a negative impact on diabetes . Interventions aim ed at reducing depressive symptoms may positively influence diabetes-specific quality of life as well . METHODS A pragmatic , r and omized controlled trial was carried out comparing the intervention with usual care among 208 Dutch primary care patients of ≥60 years with type 2 diabetes and co-occurring minor to moderate depression . Data on symptom distress and emotional distress were collected during 2003 - 2006 , and haemoglobin A1c levels were obtained from general practice s. Data were analysed using mixed model , repeated measures ANCOVAS . Hba1c was collected retrospectively from general practice s between December 2006-February 2007 . In July 2007 we retrieved some additional HbA1c data from the medical records of the university hospital . RESULTS Only in higher-educated persons did the intervention have statistically significant effect on both emotional distress and symptom distress ( DSC-R total score at 9 months P=0.001 ; PAID , 9 months P=0.03 ) . Furthermore , we found an effect on symptom distress in men ( 9 months P=0.01 ) , and on emotional distress in persons with a shorter diabetes duration ( < 7 years ) ( 9 months P=0.04 ) . A significant trend over time for haemoglobin A1c was found in favour of the intervention , with a statistically significant difference between groups after 9 months ( P=0.02 ) . CONCLUSION The nurse-administered intervention had limited effects on diabetes-specific quality of life . As only certain subgroups benefited , ways of increasing effectiveness in other groups should be explored . The potentially beneficial effect on glycaemic control is encouraging and needs further research because of small numbers in the analysis OBJECTIVE To determine the incremental cost-effectiveness and net benefit of a depression collaborative care program compared with usual care for patients with diabetes and depression . RESEARCH DESIGN AND METHODS This article describes a preplanned subgroup analysis of patients with diabetes from the Improving Mood-Promoting Access to Collaborative ( IMPACT ) r and omized controlled trial . The setting for the study included 18 primary care clinics from eight health care organizations in five states . A total of 418 of 1,801 patients r and omized to the IMPACT intervention ( n = 204 ) versus usual care ( n = 214 ) had coexisting diabetes . A depression care manager offered education , behavioral activation , and a choice of problem-solving treatment or support of antidepressant management by the primary care physician . The main outcomes were incremental cost-effectiveness and net benefit of the program compared with usual care .  RESULTS Relative to usual care , intervention patients experienced 115 ( 95 % CI 72 - 159 ) more depression-free days over 24 months . Total outpatient costs were 25 dollars ( 95 % CI -1,638 to 1,689 ) higher during this same period . The incremental cost per depression-free day was 25 cents ( -14 dollars to 15 dollars ) and the incremental cost per quality -adjusted life year ranged from 198 dollars ( 144 - 316 ) to 397 dollars ( 287 - 641 ) . An incremental net benefit of 1,129 dollars ( 692 - 1,572 ) was found . CONCLUSIONS The IMPACT intervention is a high-value investment for older adults with diabetes ; it is associated with high clinical benefits at no greater cost than usual care BACKGROUND : The comorbidity of type 2 diabetes mellitus ( T2DM ) and depression is associated with poor glycemic control .  Exercise has been shown to improve mood and glycemic control , but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise . Behavioral activation , an evidence -based depression psychotherapy , was design ed to help people with depression make gradual behavior changes , and may be helpful to build exercise adherence in sedentary population s. This pilot r and omized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression . METHODS / DESIGN : Sedentary women with inadequately controlled T2DM and depression ( N=60 ) will be r and omly assigned to one of two conditions : exercise or usual care .  Participants r and omized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care . Participants r and omized to the  usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity . Assessment s will occur at baseline and 3- , 6- , and 9-months following r and omization . The goals of this pilot study are to demonstrate feasibility and intervention acceptability , estimate the re sources and costs required to deliver the intervention and to estimate the st and ard deviation of continuous outcomes ( e.g. , depressive symptoms and glycosylated hemoglobin ) in preparation for a fully-powered r and omized clinical trial . DISCUSSION : A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression . TRIAL REGISTRATION : NCT01024790 PURPOSE We tested the feasibility and preliminary efficacy of a lifestyle intervention for middle-aged and older patients with schizophrenia and type-2 diabetes mellitus , using a r and omized pre-test , post-test control group design . METHOD Individuals with a diagnosis of schizophrenia or schizoaffective disorder over the age of 40 were r and omly assigned to 24-week Diabetes Awareness and Rehabilitation Training ( DART ; n=32 ) groups or Usual Care plus Information ( UCI ; n=32 ) comparison groups .  Participants were recruited from board- and -care facilities and day treatment programs . Fifty-seven patients completed baseline and 6-month assessment s consisting of an interview , measures of body mass index , blood pressure , fasting blood chemistry , and accelerometry . A mixed-model analysis of variance was used to analyze the data . RESULTS A significant group x time interaction was found for body weight , with patients in the DART group losing a mean of 5 lb and those in the UCI gaining a mean 6 lb . Significant group x time interactions were also found for triglycerides , diabetes knowledge , diabetes self-efficacy , and self-reported physical activity , but not for fasting plasma glucose or glycosylated hemoglobin . CONCLUSIONS Group-based lifestyle interventions are feasible and produce positive health changes in middle-aged and older patients with schizophrenia and diabetes mellitus Little is known about which factors may adversely affect response to  psychotherapy  in diabetic patients with major depression . We studied the relationship of various demographic , diabetes , and depression characteristics to change in depression in 42 patients with type 2 diabetes who completed a r and omized clinical trial of cognitive behavior therapy ( CBT ) .  Depression remitted in a significantly greater percentage of the patients treated with CBT than with the control intervention ( 85.0 % vs 27.3 % , p < 0.001 ) . In the sample as a whole , nonremission of depression was associated with lower compliance with blood glucose monitoring , higher glycated hemoglobin ( GHb ) levels , higher weight , and a history of previous treatment for depression . In the group treated with CBT , the presence of diabetes complications and lower compliance with blood glucose monitoring were significant independent predictors of diminished response . These findings show that factors related to the medical illness , such as the presence of diabetes complications , may negatively influence the prognosis for recovery from depression . Specific coverage of these issues during psychotherapy may optimize the likelihood of treatment success in patients with diabetes CONTEXT Patients with depression and poorly controlled diabetes mellitus , coronary heart disease ( CHD ) , or both have higher medical complication rates and higher health care costs , suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life . OBJECTIVE To evaluate the cost-effectiveness of a multicondition collaborative treatment program ( TEAMcare ) compared with usual primary care ( UC ) in out patients with depression and poorly controlled diabetes or CHD . DESIGN R and omized controlled trial of a systematic care management program aim ed at improving depression scores and hemoglobin A(1c ) ( HbA(1c ) ) , systolic blood pressure ( SBP ) , and low-density lipoprotein cholesterol ( LDL-C ) levels . SETTING Fourteen primary care clinics of an integrated health care system . PATIENTS Population -based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD . INTERVENTION Physician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors . MAIN OUTCOME MEASURES Blinded assessment s evaluated depressive symptoms , SBP , and HbA(1c ) at baseline and at 6 , 12 , 18 , and 24 months . Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months . Health plan accounting records were used to assess medical service costs . Quality -adjusted life-years ( QALYs ) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c ) , LDL-C , and SBP levels over 24 months . RESULTS Over 24 months , compared with UC controls , intervention patients had a mean of 114 ( 95 % CI , 79 to 149 ) additional depression-free days and an estimated 0.335 ( 95 % CI , -0.18 to 0.85 ) additional QALYs . Intervention patients also had lower mean outpatient health costs of $ 594 per patient ( 95 % CI , -$3241 to $ 2053 ) relative to UC patients . CONCLUSIONS For adults with depression and poorly controlled diabetes , CHD , or both , a systematic intervention program aim ed at improving depression scores and HbA(1c ) , SBP , and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs . TRIAL REGISTRATION clinical trials.gov Identifier : OBJECTIVE To review reliability , validity , and normative data from 7 different studies , involving a total of 1,988 people with diabetes , and provide a revised version of the Summary of Diabetes Self-Care Activities ( SDSCA ) measure . RESEARCH DESIGN AND METHODS The SDSCA measure is a brief self-report question naire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen : general diet , specific diet , exercise , blood-glucose testing , foot care , and smoking . Normative data ( means and SD ) , inter-item and test-retest reliability , correlations between the SDSCA subscales and a range of criterion measures , and sensitivity to change scores are presented for the 7 different studies ( 5 r and omized interventions and 2 observational studies ) . RESULTS Participants were typically older patients , having type 2 diabetes for a number of years , with a slight preponderance of women . The average inter-item correlations within scales were high ( mean = 0.47 ) , with the exception of specific diet ; test-retest correlations were moderate ( mean = 0.40 ) . Correlations with other measures of diet and exercise generally supported the validity of the SDSCA subscales ( mean = 0.23 ) . CONCLUSIONS There are numerous benefits from st and ardization of measures across studies . The SDSCA question naire is a brief yet reliable and valid self-report measure of diabetes self-management that is useful both for research and practice . The revised version and its scoring are presented , and the inclusion of this measure in studies of diabetes self-management is recommended when appropriate Background The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades . Improving the self-management skills of patients is a strategy to steer against this burden . This could lead to better outcomes and lower healthcare costs . Health coaching is one method for enhancing the self-management of patients and can be delivered by phone . The effects of telephone-based health coaching are promising , but still inconclusive . Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare . Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany . Methods / Design The study is a prospect i ve r and omized controlled trial comparing the effects of telephone-based health coaching with usual care during a 4-year time period . Data are collected at baseline and after 12 , 24 and 36 months . Patients are selected based on one of the following chronic conditions : diabetes , coronary artery disease , asthma , hypertension , heart failure , COPD , chronic depression or schizophrenia . The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance . The frequency and the topics of the health coaching are manual-based but tailored to the patients ’ needs and medical condition , following the concepts of motivational interviewing , shared decision-making and evidence -based-medicine . Approximately 12,000 insurants will be enrolled and r and omized into intervention and control groups . Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching , assessed by routine data . Secondary outcomes are patient-reported outcomes like changes in quality of life , depression and anxiety and clinical values assessed with question naires . Additional secondary outcomes are further economic evaluations like health service use as well as costs and hospital readmission rates . The statistical analyses includes intention-to-treat and as-treated principles . The recruitment will be completed in September 2014 . Discussion This study will provide evidence regarding economic and clinical effects of telephone-delivered health coaching . Additionally , this study will show whether health coaching is an adequate option for the German healthcare system to address the growing burden of chronic diseases . Trial registration German Clinical Trials Register ( Deutsches Register Klinischer Studien ; DRKS ) DRKS00000584 PURPOSE Depression commonly accompanies diabetes , result ing in reduced adherence to medications and increased risk for morbidity and mortality . The objective of this study was to examine whether a simple , brief integrated approach to depression and type 2 diabetes mellitus ( type 2 diabetes ) treatment improved adherence to oral hypoglycemic agents and antidepressant medications , glycemic control , and depression among primary care patients . METHODS We undertook a r and omized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care . Patients were r and omly assigned to an integrated care intervention or usual care . Integrated care managers collaborated with physicians to offer education and guideline -based treatment recommendations and to monitor adherence and clinical status . Adherence was assessed using the Medication Event Monitoring System ( MEMS ) . We used  glycated hemoglobin ( HbA1c ) assays  to measure glycemic control and the 9-item Patient Health Question naire ( PHQ-9 ) to assess depression . RESULTS Intervention and usual care groups did not differ statistically on baseline measures . Patients who received the intervention were more likely to achieve HbA1c levels of less than 7 % ( intervention 60.9 % vs usual care 35.7 % ; P < .001 ) and remission of depression ( PHQ-9 score of less than 5 : intervention 58.7 % vs usual care 30.7 % ; P < .001 ) in comparison with patients in the usual care group at 12 weeks . CONCLUSIONS A r and omized controlled trial of a simple , brief intervention integrating treatment of type 2 diabetes and depression was successful in improving outcomes in primary care . An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practice s with competing dem and s for limited re sources
target: Research ers noted small improvements in body mass index immediately after the intervention was provided and at six months , along with improved weight post intervention .
  Diabetes knowledge and self efficacy improved immediately following receipt of the intervention , and knowledge also at six months .
  The intervention did not improve blood pressure .
  Evidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes .
background: BACKGROUND People with severe mental illness are twice as likely to develop type 2 diabetes as those without severe mental illness .
  Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all .
  However , for people with severe mental illness , physical health may be a low priority , and motivation to change may be limited .
  These additional challenges mean that the findings reported in previous systematic review s of diabetes self management interventions may not be generalised to those with severe mental illness , and that tailored approaches to effective diabetes education may be required for this population .
  OBJECTIVES To assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness .