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. Integrating type 2 diabetes mellitus and depression treatment among African Americans: a randomized controlled pilot trial. A randomized trial of telephonic counseling plus walking for depressed diabetes patients. The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Web-based depression treatment for type 1 and type 2 diabetic patients: a randomized, controlled trial. Cognitive behavior therapy for depression in type 2 diabetes mellitus. A randomized, controlled trial. Collaborative care for patients with depression and chronic illnesses. Glycemic control improvement through treatment of depression using antidepressant drugs in patients with diabetes mellitus type 1. Collaborative care management of major depression among low-income, predominantly Hispanic subjects with diabetes: a randomized controlled trial. Psychotherapy intervention to reduce depressive symptoms in patients with diabetic foot syndrome. Quality of life and metabolic status in mildly depressed patients with type 2 diabetes treated with paroxetine: a double-blind randomised placebo controlled 6-month trial. Effect of pharmacological treatment of depression on A1C and quality of life in low-income Hispanics and African Americans with diabetes: a randomized, double-blind, placebo-controlled trial. The impact of pharmaceutical care on the clinical outcome of diabetes mellitus among a rural patient population. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control.
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.
                Depression is common among persons with diabetes and may have a negative impact on diabetes. Interventions aimed at reducing depressive symptoms may positively influence diabetes-specific quality of life as well.
                A pragmatic, randomized 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 practices. Data were analysed using mixed model, repeated measures ANCOVAS. Hba1c was collected retrospectively from general practices between December 2006-February 2007. In July 2007 we retrieved some additional HbA1c data from the medical records of the university hospital.
                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).
                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.
                © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd. 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.
                Older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice in west Philadelphia were randomly 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 standard laboratory tests to measure glycemic control and the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression.
                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.
                A pilot randomized 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 practices with competing demands for limited resources. Patients with diabetes and depression often have self-management needs that require between-visit support. This study evaluated the impact of telephone-delivered cognitive behavioral therapy (CBT) targeting patients' management of depressive symptoms, physical activity levels, and diabetes-related outcomes.
                Two hundred ninety-one patients with type 2 diabetes and significant depressive symptoms (Beck Depression Inventory scores ≥ 14) were recruited from a community-based, university-based, and Veterans Affairs health care systems. A manualized telephone CBT program was delivered weekly by nurses for 12 weeks, followed by 9 monthly booster sessions. Sessions initially focused exclusively on patients' depression management and then added a pedometer-based walking program. The primary outcome was hemoglobin A1c levels measured at 12 months. Blood pressure was a secondary outcome; levels of physical activity were determined by pedometer readings; depression, coping, and health-related quality of life were measured using standardized scales.
                Baseline A1c levels were relatively good and there was no difference in A1c at follow-up. Intervention patients experienced a 4.26 mm Hg decrease in systolic blood pressure relative to controls (P=0.05). Intervention patients had significantly greater increases in step counts (mean difference, 1131 steps/d; P=0.0002) and greater reductions in depressive symptoms (58% remitted at 12 mo vs. 39%; P=0.002). Intervention patients also experienced relative improvements in coping and health-related quality of life.
                This program of telephone-delivered CBT combined with a pedometer-based walking program did not improve A1c values, but significantly decreased patients' blood pressure, increased physical activity, and decreased depressive symptoms. The intervention also improved patients' functioning and quality of life. 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.
                To determine whether enhancing quality of care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.
                Randomized controlled trial with recruitment from March 1, 2001, to May 31, 2002.
                Nine primary care clinics from a large health maintenance organization.
                A total of 329 patients with diabetes mellitus and comorbid major depression and/or dysthymia. Intervention Patients were randomly 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.
                Independent blinded assessments 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.
                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.
                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. 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.
                A randomized controlled trial was conducted in the Netherlands in 255 adult diabetic patients with elevated depressive symptoms. Primary outcomes were depressive symptoms. Secondary outcomes were diabetes-specific emotional distress and glycemic control. Assessments were at baseline, after treatment, and at the 1-month follow-up.
                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).
                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. Psychotherapy is the principal nonpharmacologic method for the management of depression, but its usefulness for depressed patients with diabetes remains unknown.
                To assess the efficacy of cognitive behavior therapy (CBT) for depression in patients with diabetes.
                Randomized, controlled trial.
                Referral-based academic medical center.
                51 patients with type 2 diabetes and major depression.
                Patients were assigned either to a group that received 10 weeks of individual CBT or to a control group that received no specific antidepressant treatment. All patients participated in a diabetes education program to control for the effects of supportive attention and the possible influence of enhanced diabetes control on mood.
                Degree of depression was measured by using the Beck Depression Inventory; glycemic control was measured by using glycosylated hemoglobin levels. Outcomes were assessed immediately after treatment and 6 months after treatment.
                The percentage of patients achieving remission of depression (Beck Depression Inventory score < or = 9) was greater in the CBT group than in the control group: posttreatment, 85.0% of patients in the CBT group (17 of 20) compared with 27.3% of controls (6 of 22) achieved remission (difference, 57.7 percentage points [95% CI, 33 to 82 percentage points]) (P < 0.001); at follow-up, 70.0% of patients in the CBT group (14 of 20) compared with 33.3% of controls (7 of 21) achieved remission (difference, 36.7 percentage points [CI, 9 to 65 percentage points]) (P = 0.03). Post-treatment glycosylated hemoglobin levels were not different in the two groups, but follow-up mean glycosylated hemoglobin levels were significantly better in the CBT group than in the control group (9.5% compared with 10.9%; P = 0.03).
                The combination of CBT and supportive diabetes education is an effective nonpharmacologic treatment for major depression in patients with type 2 diabetes. It may also be associated with improved glycemic control. Patients with depression and poorly controlled diabetes, coronary heart disease, or both have an increased risk of adverse outcomes and high health care costs. We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients.
                We conducted a single-blind, randomized, controlled trial in 14 primary care clinics in an integrated health care system in Washington State, involving 214 participants with poorly controlled diabetes, coronary heart disease, or both and coexisting depression. Patients were randomly assigned to the usual-care group or to the intervention group, in which a medically supervised nurse, working with each patient's primary care physician, provided guideline-based, collaborative care management, with the goal of controlling risk factors associated with multiple diseases. The primary outcome was based on simultaneous modeling of glycated hemoglobin, low-density lipoprotein (LDL) cholesterol, and systolic blood-pressure levels and Symptom Checklist-20 (SCL-20) depression outcomes at 12 months; this modeling allowed estimation of a single overall treatment effect.
                As compared with controls, patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels (difference, 0.58%), LDL cholesterol levels (difference, 6.9 mg per deciliter [0.2 mmol per liter]), systolic blood pressure (difference, 5.1 mm Hg), and SCL-20 depression scores (difference, 0.40 points) (P<0.001). Patients in the intervention group also were more likely to have one or more adjustments of insulin (P=0.006), antihypertensive medications (P<0.001), and antidepressant medications (P<0.001), and they had better quality of life (P<0.001) and greater satisfaction with care for diabetes, coronary heart disease, or both (P<0.001) and with care for depression (P<0.001).
                As compared with usual care, an intervention involving nurses who provided guideline-based, patient-centered management of depression and chronic disease significantly improved control of medical disease and depression. (Funded by the National Institute of Mental Health; ClinicalTrials.gov number, NCT00468676.). Depression is a common disorder among diabetic patients and affects negatively the treatment of their basic disease. The aim of the study was to assess, whether antidepressant medication could positively influence glycemic control of diabetes type 1 in depressive or anxious patients.
                A six-month, double-blinded, randomized, placebo-controlled study was performed to investigate the reaction of type 1diabetic patients (n=21) to treatment of depression and anxiety symptoms using antidepressant drug sertraline. The patients were given sertraline (100 mg/day) or placebo. The evolution of mental change was assessed using Zung Self-Rating Depression Scale (SDS), Hamilton Anxiety Rating Scale (HAMA) and Hamilton Depression Rating Scale (HAMD) along with development of somatic parameters commonly assessed in diabetic patients, especially glycosylated hemoglobin, insulin dose and body weight. The level of active substance in serum of the patients was also measured.
                Mental state improved at the level of statistical significance of p<0.001 in both patients using antidepressant and placebo. From somatic parameters, body weight and systolic blood pressure increased statistically significantly also in both groups of patients.
                The mental state of most patients who successfully completed the study improved regardless of the fact if they were using antidepressant or placebo. No statistically significant connections between the mental and somatic changes were found. This finding points out to the placebo effect of the medication, to the importance of a contact with patients, but also to the need to concentrate on their mental state. To determine whether evidence-based socioculturally adapted collaborative depression care improves receipt of depression care and depression and diabetes outcomes in low-income Hispanic subjects.
                This was a randomized controlled trial of 387 diabetic patients (96.5% Hispanic) with clinically significant depression recruited from two public safety-net clinics from August 2005 to July 2007 and followed over 18 months. Intervention (INT group) included problem-solving therapy and/or antidepressant medication based on a stepped-care algorithm; first-line treatment choice; telephone treatment response, adherence, and relapse prevention follow-up over 12 months; plus systems navigation assistance. Enhanced usual care (EUC group) included standard clinic care plus patient receipt of depression educational pamphlets and a community resource list.
                INT patients had significantly greater depression improvement (> or =50% reduction in Symptom Checklist-20 depression score from baseline; 57, 62, and 62% vs. the EUC group's 36, 42, and 44% at 6, 12, and 18 months, respectively; odds ratio 2.46-2.57; P < 0.001). Mixed-effects linear regression models showed a significant study group-by-time interaction over 18 months in diabetes symptoms; anxiety; Medical Outcomes Study Short-Form Health Survey (SF-12) emotional, physical, and pain-related functioning; Sheehan disability; financial situation; and number of social stressors (P = 0.04 for disability and SF-12 physical functioning, P < 0.001 for all others) but no study group-by-time interaction in A1C, diabetes complications, self-care management, or BMI.
                Socioculturally adapted collaborative depression care improved depression, functional outcomes, and receipt of depression treatment in predominantly Hispanic patients in safety-net clinics. Compared to the population as a whole, patients with diabetes mellitus suffer a significantly higher rate of depressive symptoms, especially when they develop complications. Psychotherapy treatments in diabetes mellitus can lead to improvements in both depressive symptoms and glycaemic control. The objective of this study was to investigate whether depressive symptoms can be reduced by psychotherapy treatment delivered as a joint interdisciplinary service to in-patients with diabetic foot syndrome and comorbid depression.
                Thirty in-patients with diabetic foot syndrome and comorbid depression were randomized to either an intervention group (n = 15) with supportive psychotherapy treatment or a control group (n = 15) that received only standard medical treatment. Patients completed a set of questionnaires at the beginning and end of treatment. These recorded sociodemographic variables, anxiety and depression (Hospital Anxiety and Depression Scale) and diabetes-related problems (Problem Areas in Diabetes Scale).
                Although the diabetic foot syndrome improved significantly in 75% of patients, the extent of depressive symptoms and anxiety reported by the control group did not decrease by the end of treatment. In contrast, in the intervention group, anxiety, depression and diabetes-related problems were all reduced. The extent of anxiety and depression was not, as had been anticipated, associated with the severity of the physical symptoms.
                These results indicate that psychotherapeutic intervention during in-patient treatment can have a positive influence on anxiety, depressive symptoms and diabetes-related problems in patients with diabetic foot syndrome. Depression is prevalent in people with type 2 diabetes and affects both glycaemic control and overall quality of life. The aim of this investigator-initiated trial was to evaluate the effect of the antidepressant paroxetine on quality of life, metabolic control, and mental well-being in mildly depressed diabetics aged 50-70 years.
                We randomised 49 mildly depressed primary care outpatients with non-optimally controlled diabetes to a 6-month double-blind treatment with either paroxetine 20 mg per day or matching placebo. Primary efficacy measurements were quality of life and glycaemic control. The primary global outcome of the study was defined as a 10 points improvement in the SF-36 quality of life score. The primary metabolic outcome of the study was defined as a 0.8%-units decrease in glycosylated haemoglobin A1c(GHbA1c). Psychiatric symptoms were assessed with the Hospital Anxiety and Depression Scale.
                Six patients withdrew their consent before starting medication and six dropped out later in the study. We performed analysis of covariance with the baseline value as a covariate. Quality of life and glycaemic control as well as symptoms of depression and anxiety improved in both groups over the 6-month study period. After three months of treatment we found a statistically significant difference between the two treatment groups in GHbA1c (mean difference = 0.59%-units, p = 0.018) and in SF-36 score (mean difference = 11.0 points, p = 0.039). However, at the end of the study, no statistically significant differences between the treatment groups were observed. No severe adverse events occurred.
                This pragmatic study of primary care patients did not confirm earlier preliminary findings indicating a beneficial effect of paroxetine on glycaemic control. The study indicates that in pragmatic circumstances any possible benefit from administration of paroxetine in diabetic patients with sub-threshold depression is likely to be modest and of short duration. Routine antidepressant prescription for patients with diabetes and sub-threshold depressive symptoms is not indicated.
                Current controlled trials ISRCTN55819922. To determine whether pharmacological treatment of depression in low-income minorities with diabetes improves A1C and quality of life (QOL).
                This was a 6-month, randomized, double-blind, placebo-controlled trial. Patients were screened for depression using Whooley's two-question tool at a county diabetes clinic. Depression was confirmed (or not) with the Computerized Diagnostic Interview Survey (CDIS) software program, and the severity of depression was assessed monthly by the Hamilton Depression Scale (HAM-D). Depressed subjects with A1C levels >or=8.0% were randomly assigned to receive either sertraline or placebo. Diabetes care was provided by nurses following detailed treatment algorithms who were unaware of therapy for depression.
                A total of 150 subjects answered positively to at least one question on Whooley's questionnaire. The positive predictive value for depression diagnosed by CDIS was 69, 67, and 84% for positive answers to question 1 only, question 2 only, or both, respectively. Of the 89 subjects who entered the study, 75 completed. An intention-to-treat analysis revealed significant differences between baseline and 6 months in HAM-D and pain scores, QOL, and A1C and systolic blood pressure levels in both groups, with no differences between groups for the first three but a significantly greater decrease with sertraline in A1C and systolic blood pressure levels. Changes in HAM-D scores and A1C levels were significantly correlated in all subjects (P = 0.45 [P < 10(-6)]).
                In this low-income minority population, pharmacological treatment of depression significantly improved A1C and systolic blood pressure levels compared with placebo. To evaluate the impact of pharmaceutical care on the clinical outcomes of patients enrolled in a pharmacist-coordinated diabetes management program in a rural health setup.
                Patients were registered into 'control' and 'intervention' groups by randomization at three primary health centers. The study was an open-label parallel study.
                Medical records were prospectively reviewed. Capillary blood glucose level, blood pressure and demographic data were collected at baseline and at the follow-up visits. Pharmacists gave counseling to the intervention group during every visit and their health-related quality of life (HRQoL) was assessed with the Ferrans and Powers questionnaire.
                Single factor ANOVA and the t-test were used to compare the results using SPSS version 0.9 software and MS Excel worksheets.
                The intervention group (n = 104) showed well-controlled BMI, whereas the control group (n = 50) showed significant increase in the BMI. Mean blood glucose level in the intervention group reduced to 25 units from baseline (P = 0.0001) but was significantly increased in the control group (P = 0.0001). ANOVA showed that from the second follow-up onward there was significant decrease in blood glucose levels. Overall, the HRQoL scores increased by 45% in the intervention group and decreased by 2% in the control group.
                The pharmaceutical care program was effective in improving the clinical outcome and HRQoL of diabetes patients in rural India. Such 'pharmaceutical care' models should be fine-tuned and implemented widely. To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes.
                A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in analysis. The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period. Secondary outcomes were changes in patient-reported diabetes symptoms, diabetes distress, depression, and other clinical (blood pressure) and laboratory (lipid) values. Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support. Patients received automated, real-time educational and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by mobile phone. Providers received quarterly reports summarizing patient's glycemic control, diabetes medication management, lifestyle behaviors, and evidence-based treatment options.
                The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual care group, a difference of 1.2% (P < 0.001) over 12 months. Appreciable differences were not observed between groups for patient-reported diabetes distress, depression, diabetes symptoms, or blood pressure and lipid levels (all P > 0.05).
                The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year.
Psychological and pharmacological interventions have a moderate and clinically significant effect on depression outcomes in diabetes patients. Glycaemic control improved moderately in pharmacological trials, while the evidence is inconclusive for psychological interventions. Adherence to diabetic treatment regimens, diabetes complications, death from any cause, health economics and QoL have not been investigated sufficiently. Overall, the evidence is sparse and inconclusive due to several low-quality trials with substantial risk of bias and the heterogeneity of examined populations and interventions.