title: Effects of social support and education on health care costs for patients with fibromyalgia. Cognitive-behavioral therapy for insomnia improves attentional function in fibromyalgia syndrome: A pilot, randomized controlled trial Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments Does self-management education benefit all populations with arthritis? A randomized controlled trial in a primary care physician network. Effectiveness of a Psychoeducational Treatment Program Implemented in General Practice for Fibromyalgia Patients: A Randomized Controlled Trial Affective-Cognitive Behavioral Therapy for Fibromyalgia: A Randomized Controlled Trial Treating fibromyalgia with mindfulness-based stress reduction: Results from a 3-armed randomized controlled trial A prospective, longitudinal, multicenter study of service utilization and costs in fibromyalgia. Cognitive Behavioral Therapy increases pain-evoked activation of the prefrontal cortex in patients with fibromyalgeia Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. Psychological interventions for pediatric chronic pain – The good news and the challenges ahead Mail-delivered arthritis self-management tool kit: a randomized trial and longitudinal followup. Differential efficacy of a cognitive – behavioral intervention versus pharmacological treatment in the management of fibromyalgic syndrome A scale for rating the quality of psychological trials for pain The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials. Sleep problems and risk of fibromyalgia: longitudinal data on an adult female population in Norway. Internet-enhanced management of fibromyalgia: A randomized controlled trial Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial Hypnotic Treatment Synergizes the Psychological Treatment of Fibromyalgia: A Pilot Study Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Attention Modification in Persons with Fibromyalgia: A Double Blind, Randomized Clinical Trial Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Long-term efficacy of therapy in patients with fibromyalgia: a physical exercise-based program and a cognitive-behavioral approach. Efficacy of cognitive-behavioral intervention for juvenile primary fibromyalgia syndrome. The effects of exercise and education, individually or combined, in women with fibromyalgia. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Operant behavioral treatment of fibromyalgia: a controlled study. Cognitive-educational treatment of fibromyalgia: a randomized clinical trial. I. Clinical effects. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials Pain Physiology Education Improves Health Status and Endogenous Pain Inhibition in Fibromyalgia: A Double-Blind Randomized Controlled Trial Cognitive behavior therapy, exercise, or both for treating chronic widespread pain. Multicomponent cognitive-behavioral group therapy with hypnosis for the treatment of fibromyalgia: long-term outcome. Responder criteria for operant and cognitive-behavioral treatment of fibromyalgia syndrome.
abstract: OBJECTIVE The rising costs of health care are of great concern , particularly for the chronically ill . Interventions that promote health status and well being while teaching appropriate use of the health care system have led to cost savings among patients with osteoarthritis . We carried out social support and education interventions with patients with fibromyalgia ( FM ) and assessed the effect on health care costs , psychosocial variables , and health status . METHODS Participants were 600 patients with FM who were members of a health maintenance organization . They were r and omly assigned to one of 2 experimental groups ( social support ; social support and education ) or to a no-treatment control group . Assessment s were conducted at baseline and following a one year intervention . Health care cost data were obtained directly from participants ' medical records . RESULTS Results indicated significant reductions in all groups ' costs of prescriptions , laboratory tests , and visits to a nurse , nurse practitioner and /or physicians ' assistant . All groups also showed improvements on variables assessing effect of FM , self-efficacy , depression , and knowledge of FM . The social support and education group was less helpless after one year than the other groups ; differential changes for all other variables were not significant . CONCLUSION The study did not reveal differential changes in health care costs among participants in the experimental and control groups . These findings emphasize the importance of using objective health care utilization data when calculating health care costs , as well as the value of including a no-treatment control group to prevent erroneous conclusions about treatment efficacy This pilot , r and omized controlled trial analyzed the effects of a cognitive behavioral therapy ( CBT , n = 20 ) for insomnia  vs a sleep hygiene ( SH , n = 20 ) program on the three attentional networks ( alertness , orienting , and executive function ) and other additional outcome measures ( sleep , pain , depression , anxiety , and daily functioning ) of fibromyalgia patients . The CBT group showed significant improvement in alertness ( F(1 , 28 ) = 11.84 , p = .0018 ) , executive functioning ( F(1 , 28 ) = 15.76 , p = .00059 ) , sleep quality ( F(1 , 38 ) = 6.33 , p = .016 ) , and a trend to improvement in daily functioning ( p > .06 ) , as compared with the SH group . The improvement in executive functioning was significantly related to the changes in sleep ( r = 0.40 , p = .026 ) . A CBT for insomnia represents a useful intervention in fibromyalgia patients not only regarding sleep disturbance but also attentional dysfunction and probably daily functioning The present study focused on the evaluation of the effects of operant behavioural ( OBT ) and cognitive behavioural ( CBT ) treatments for fibromyalgia syndrome ( FMS ) . One hundred and twenty-five patients who fulfilled the American College of Rheumatology criteria for FMS were r and omly assigned to OBT ( n = 43 ) , CBT ( n = 42 ) , or an attention-placebo ( AP ) treatment ( n = 40 ) that consisted of discussion s of FMS-related problems . Assessment s of physical functioning , pain , affective distress , and cognitive and behavioural variables were performed pre-treatment and post-treatment as well as 6 and 12 months post-treatment . Patients receiving the OBT or CBT reported a significant reduction in pain intensity post-treatment ( all Fs > 3.89 , all Ps < 0.01 ) . In addition , the CBT group reported statistically significant improvements in cognitive ( all Fs > 7.95 , all P < 0.01 ) and affective variables ( all Fs > 2.99 , all Ps < 0.02 ) , and the OBT group demonstrated statistically significant improvements in physical functioning and behavioural variables ( all Fs > 5.99 , all Ps < 0.001 ) compared with AP . The AP group reported no significant improvement but actually deterioration in the outcome variables . The post-treatment effects for the OBT and CBT groups were maintained at both the 6- and 12-month follow-ups . These results suggest that both OBT and CBT are effective in treating patients with FMS with some differences in the outcome measures specifically targeted by the individual treatments compared with an unstructured discussion group . The AP group showed that unstructured discussion of FMS-related problems may be detrimental OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs  in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course .  Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course  ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients in the intervention and control groups had similar baseline pain ( p = 0.94 ) , self-efficacy to control pain ( p = 0.90 ) , mental health ( p = 0.10 ) , and vitality scores ( p = 0.21 ) , but those in the intervention arm had slightly less disability ( p = 0.04 ) . At 4 months , there was no significant improvement from baseline in any endpoint and no difference between patients in the intervention and control groups ( all p > 0.2 ) . Patient satisfaction with arthritis care and outcomes was no different for intervention and control patients ( all p > 0.3 ) . All types of health care re source use were similar at baseline and followup for both intervention and control groups ( all p > 0.2 ) . CONCLUSION While the ASMP course has been found to be effective in other patient groups , there were no significant clinical benefits noted at 4 months in patients recruited from primary care practice Objectives A recent meta- analysis concluded that multicomponent treatments are effective for some fibromyalgia ( FM ) symptoms . The objective of this study was to examine whether a psychoeducational intervention implemented in primary care is more effective than usual care for improving the functional status of patients with FM . Methods This study was based on a r and omized controlled trial . The 484 patients with FM included in a data base of the Viladecans Hospital ( Barcelona , Spain ) were eligible for screening . Finally , 108 patients were r and omly assigned to the intervention and 108 patients were assigned to usual care . The intervention comprised nine 2-hour sessions ( 5 sessions of education and 4 sessions of autogenic relaxation ) . The patients were assessed before and after the intervention with a battery of instruments ( measuring sociodemographic data , medical comorbidities , functional status , trait anxiety , and social desirability ) . Results The posttreatment drop-out rate was 9.7 % ( intervention : 6.5 % ; control : 13 % ) . The intention-to-treat analyses showed significant differences between the groups at posttreatment : the intervention group improved in physical impairment , days not feeling well , pain , general fatigue , morning fatigue , stiffness , anxiety , and depression ( medium effect size in most cases ) . The patients who responded to the intervention reported less trait anxiety at baseline than nonresponders . The absolute risk reduction with the intervention was 36.1 % ( 95 % confidence interval : 23.3 - 48.8 ) and the number needed to treat was 3 ( 95 % confidence interval : 2.0 - 4.3 ) . Discussion A 2-month psychoeducational intervention improves the functional status of FM patients to a greater extent than usual care , at least in the short-term . The social desirability bias did not explain the reported outcomes . Trait anxiety was associated with response to treatment . Trial Registration NCT00550966 A r and omized controlled trial was conducted to assess the efficacy of an individually administered form of cognitive behavioral treatment for fibromyalgia . In an additive design , 76 patients diagnosed with fibromyalgia were r and omly assigned to either the experimental treatment ( affective-cognitive behavioral therapy , 10 individual sessions , one per week ) administered concurrently with treatment-as-usual or to an unaugmented treatment-as-usual condition . Statistical analysis conducted at the end of treatment ( 3 months after the baseline assessment ) and at a followup ( 9 months after the baseline assessment ) indicated that the patients receiving the experimental treatment reported less pain and overall better functioning than control patients , both at posttreatment and at followup . The implication s of these findings for future research are discussed & NA ; Mindfulness‐based stress reduction ( MBSR ) is a structured 8‐week group program teaching mindfulness meditation and mindful yoga exercises . MBSR aims to help participants develop nonjudgmental awareness of moment‐to‐moment experience . Fibromyalgia is a clinical syndrome with chronic pain , fatigue , and insomnia as major symptoms . Efficacy of MBSR for enhanced well‐being of fibromyalgia patients was investigated in a 3‐armed trial , which was a follow‐up to an earlier quasi‐r and omized investigation . A total of 177 female patients were r and omized to one of the following : ( 1 ) MBSR , ( 2 ) an active control procedure controlling for nonspecific effects of MBSR , or ( 3 ) a  wait list  . The major outcome was health‐related quality of life ( HRQoL ) 2 months post‐treatment . Secondary outcomes were disorder‐specific quality of life , depression , pain , anxiety , somatic complaints , and a proposed index of mindfulness . Of the patients , 82 % completed the study . There were no significant differences between groups on primary outcome , but patients overall improved in HRQoL at short‐term follow‐up ( P = 0.004 ) . Post hoc analyses showed that only MBSR manifested a significant pre‐to‐post‐intervention improvement in HRQoL ( P = 0.02 ) . Furthermore , multivariate analysis of secondary measures indicated modest benefits for MBSR patients . MBSR yielded significant pre‐to‐post‐intervention improvements in 6 of 8 secondary outcome variables , the active control in 3 , and the wait list in 2 . In conclusion , primary outcome analyses did not support the efficacy of MBSR  in fibromyalgia , although patients in the MBSR arm appeared to benefit most . Effect sizes were small compared to the earlier , quasi‐r and omized investigation . Several method ological aspects are discussed , e.g. , patient burden , treatment preference and motivation , that may provide explanations for differences . In a 3‐armed r and omized controlled trial in female patients suffering from fibromyalgia , patients benefited modestly from a mindfulness‐based stress reduction intervention OBJECTIVE To study , for the first time , service utilization and costs in fibromyalgia , a prevalent syndrome associated with high levels of pain , functional disability , and emotional distress . METHODS Five hundred thirty-eight fibromyalgia patients from 6 rheumatology centers were enrolled in a 7-year prospect i ve study of fibromyalgia outcome . Patients were assessed every 6 months with vali date d , mailed question naires which included questions regarding fibromyalgia symptoms and severity , utilization of services , and work disability . RESULTS Fibromyalgia patients averaged almost 10 outpatient medical visits per year , and when nontraditional treatments were considered , this number increased to approximately 1 visit per month . Patients were hospitalized at a rate of 1 hospitalization every 3 years . In each 6-month study period , patients used a mean of 2.7  fibromyalgia-related drugs . Costs increased over the course of the study . The mean yearly per-patient cost in 1996 dollars was $ 2,274 . However , results were skewed by high utilizers , and many patients used few services and had limited costs . Total costs and utilization were independently associated with the number of self-reported comorbid or associated conditions , functional disability , and global disease severity . Compared with patients with other rheumatic disorders , those with fibromyalgia were more likely to have lifetime surgical interventions , including back or neck surgery , appendectomy , carpal tunnel surgery , gynecologic surgery , abdominal surgery , and tonsillectomy , and were more likely than other rheumatic disease patients to report comorbid or associated conditions . Almost 50 % of hospitalizations occurring during the study were related to fibromyalgia-associated symptoms . CONCLUSION The average yearly cost for service utilization among fibromyalgia patients is $ 2,274 . Fibromyalgia patients have high lifetime and current rates of utilization of all types of medical services . They report more symptoms and comorbid or associated conditions than patients with other rheumatic conditions , and symptom reporting is linked to service utilization and , to a lesser extent , functional disability and global disease severity Summary Treatment with Cognitive Behavioral Therapy leads to clinical improvements in fibromyalgia patients , paired with increased activity and connectivity in the brain ’s pain modulatory regions . ABSTRACT Interventions based on Cognitive Behavioral Therapy ( CBT ) are widely used to treat chronic pain , but the brain mechanisms responsible for these treatment effects are poorly understood . The aim of this study was to vali date the relevance of the cortical control theory in response to an exposure‐based form of CBT , Acceptance and Commitment Therapy , in patients with chronic pain . Forty‐three female patients diagnosed with fibromyalgia syndrome were enrolled in a r and omized , 12‐week , waiting‐list controlled clinical trial  ( CBT n = 25 ; controls n = 18 ) . CBT was administered in groups of six patients during 12 weekly sessions . Functional magnetic resonance imaging ( fMRI ) during pressure‐evoked pain was assessed before and after treatment or the 12‐week period .  Self‐report question  naires of depression and anxiety  were administered pre‐ and posttreatment as well as 3 months following end of treatment . Patients treated with CBT reported larger improvement of fibromyalgia on the Patient Global Impression of Change measure , and improved depression and anxiety symptoms , compared to the waiting‐list controls . However , there were no effects on clinical pain or pain sensitivity measures . An analysis of fMRI scans revealed that CBT led to increased activations in the ventrolateral prefrontal/lateral orbitofrontal cortex ; regions associated with executive cognitive control . We suggest that CBT changes the brain ’s processing of pain through an altered cerebral loop between pain signals , emotions , and cognitions ; leading to increased access to executive regions for re appraisal of pain . Our data thereby support our hypothesis about the activation of a cortical control mechanism in response to CBT treatment in chronic pain OBJECTIVE Juvenile fibromyalgia syndrome ( FMS ) is a chronic musculoskeletal pain disorder in children and adolescents for which there are no evidence -based treatments . The objective of this multisite , single-blind , r and omized clinical trial was to test whether cognitive-behavioral therapy ( CBT ) was superior to fibromyalgia ( FM ) education in reducing functional disability , pain , and symptoms of depression in juvenile FMS . METHODS Participants were 114 adolescents ( ages 11 - 18 years ) with juvenile FMS . After receiving stable medications for 8 weeks , patients were r and omized to either CBT or FM education and received 8 weekly individual sessions with a therapist and 2 booster sessions . Assessment s were conducted at baseline , immediately following the 8-week treatment phase , and at 6-month followup . RESULTS The majority of patients ( 87.7 % ) completed the trial per protocol . Intent-to-treat analyses showed that patients in both groups had significant reductions in functional disability , pain , and symptoms of depression at the end of the study , and CBT was significantly superior to FM education in reducing the primary outcome of functional disability ( mean baseline to end-of-treatment difference between groups 5.39 [ 95 % confidence interval 1.57 , 9.22 ] ) . Reduction in symptoms of depression was clinical ly significant for both groups , with mean scores in the range of normal/nondepressed by the end of the study . Reduction in pain was not clinical ly significant for either group ( < 30 % decrease in pain ) . There were no study -related adverse events . CONCLUSION In this controlled trial , CBT was found to be a safe and effective treatment for reducing functional disability and symptoms of depression in adolescents with juvenile FMS In a 2002 systematic review of pediatric clinical trials Eccleston et al. [ 1 ] found that psychological therapies had a significant effect on pain reduction . Although that review sought to include all pain conditions , the available studies at the time focused almost exclusively on treatment of pediatric headache . In recent years , r and omized clinical trials ( RCTs ) have been published on other pediatric pain conditions , including abdominal pain and fibromyalgia . In addition , effects of psychological therapies on clinical outcomes beyond pain reduction , such as functional disability and emotional distress were examined . In this issue of Pain , Palermo et al. [ 4 ] present a timely meta-analytic review paper that reflects on these new developments OBJECTIVE To determine the effectiveness of an intervention Tool Kit of arthritis self-management material s to be sent once through the mail , and to describe the population s reached . METHODS Spanish speakers ( n = 335 ) , non-Hispanic English-speaking African Americans ( n = 156 ) , and other non-Hispanic English speakers ( n = 404 ) were recruited separately and r and omized within each of the 3 ethnic/racial categories to immediately receive the intervention Tool Kit  ( n = 458 ) or to a 4-month wait-list control status ( n = 463 ) . At the end of 4 months , controls were sent the Tool Kit . All subjects were followed in a longitudinal study for 9 months . Self-administered measures included health status , health behavior , arthritis self-efficacy , medical care utilization , and demographic variables . Using analyses of covariance and t-tests , analyses were conducted for all participants and for Spanish- and English- language groups . RESULTS At 4 months , comparing all intervention subjects with r and omized wait-list controls , there were significant ( P < 0.01 ) benefits in all outcomes except medical care utilization and self-rated health . The results were maintained at 9 months compared with baseline . On average , the Tool Kit reached persons ages 50 - 56 years with 12 - 15 years of schooling . There were few differences between English- and Spanish- language participants in either the effectiveness or reach variables . CONCLUSION A mailed Arthritis Self-Management Tool Kit proved effective in improving health status , health behavior , and self-efficacy variables for up to 9 months . It also reached younger persons in both English- and Spanish- language groups and Spanish speakers with higher education levels than previous studies of the small-group Arthritis Self-Management Program Abstract Given that studies about the differential efficacy of existing treatments in fibromyalgia syndrome are scarce , the aim of this study was to compare the differential efficacy of a cognitive – behavioral and a pharmacological therapy on fibromyalgia . Using a r and omized controlled clinical trial , 28 fibromyalgic patients were assigned to one of following experimental conditions : ( a ) pharmacological treatment ( i.e. , cyclobenzaprine ) , ( b ) cognitive – behavioral intervention ( i.e. , stress inoculation training ) , ( c ) combined pharmacological and cognitive – behavioral treatment and ( d ) no treatment . The results show the superiority of  cognitive – behavioral intervention to reduce the severity of fibromyalgia both at the end of the treatment and at follow-up . We conclude that cognitive – behavioral interventions must be considered a primary treatment of fibromyalgia syndrome & NA ; This paper reports the development of a scale for assessing the quality of reports of r and omised controlled trials for psychological treatments .  The Delphi method was used in which a panel of 15–12 experts generated statements relating to treatment and design components of trials . After three rounds , statements with high consensus agreement were review ed by a second expert panel and rewritten as a scale . Evidence to support the reliability and validity of the scale is reported . Three expert and five novice raters assessed sets of 31 and 25 published trials to establish scale reliability ( ICC ranges from 0.91 to 0.41 for experts and novices , respectively ) and item reliability ( Kappa and inter‐rater agreement ) . The total scale score discriminated between trials globally judged as good and poor by experts , and trial quality was shown to be a function of year of publication . Uses for the scale are suggested The logic of the r and omized double-blind placebo control group design is presented , and problems with using the design in psychotherapy are discussed .  Placebo effects are estimated by examining clinical trials in medicine and psychotherapy . In medicine , a recent meta- analysis of clinical trials with treatment , placebo , and no treatment arms was conducted ( Hróbjartsson & Gøtzsche , 2001 ) , and it was concluded that placebos have small or no effects . A re- analysis of those studies , presented here , shows that when disorders are amenable to placebos and the design is adequate to detect the effects , the placebo effect is robust and approaches the treatment effect . For psychological disorders , particularly depression , it has been shown that pill placebos are nearly as effective as active medications whereas psychotherapies are more effective than psychological placebos . However , it is shown that when properly design ed , psychological placebos are as effective as accepted psychotherapies OBJECTIVE Sleep problems are common among patients with fibromyalgia ( FM ) . However , it is not known whether poor sleep is a contributing factor in FM or a consequence of the illness . The aim of the current study was to prospect ively investigate the association between self-reported sleep problems and risk of FM among adult women . METHODS We longitudinally studied 12,350 women who did not have FM , musculoskeletal pain , or physical impairments at baseline ( 1984 - 1986 ) . A generalized linear model was used to calculate the adjusted relative risk ( RR ) of FM at followup in 1995 - 1997 . RESULTS Incident FM was reported by 327 women at followup . A dose-dependent association was found between sleep problems and risk of FM ( P for trend<0.001 ) , with an adjusted RR of 3.43 ( 95 % confidence interval [ 95 % CI ] 2.26 - 5.19 ) among women who reported having sleep problems often or always , compared to women who never experienced sleep problems . Age-stratified analysis showed that women age≥45 years who reported having sleep problems often or always had an adjusted RR of 5.41 ( 95 % CI 2.65 - 11.05 ) , whereas the corresponding RR for women ages 20 - 44 years who reported having sleep problems often or always was 2.98 ( 95 % CI 1.76 - 5.05 ) . CONCLUSION These prospect i ve data indicate a strong dose-dependent association between sleep problems and risk of FM . The association is somewhat , although not significantly , stronger in middle-aged and older women than in younger women & NA ; Both pharmacological and non‐pharmacological interventions have demonstrated efficacy in the management of fibromyalgia ( FM ) .  Non‐pharmacological interventions however are far less likely to be used in clinical setting s , in part due to limited access . This manuscript presents the findings of a r and omized controlled trail of an Internet‐based exercise and behavioral self‐management program for FM design ed for use in the context of a routine clinical care . 118 individuals with FM were r and omly assigned to either ( a ) st and ard care or ( b ) st and ard care plus access to a Web‐Enhanced Behavioral Self‐Management program ( WEB‐SM ) grounded in cognitive and behavioral pain management principles . Individuals were assessed at baseline and again at 6 months for primary endpoints : reduction of pain and an improvement in physical functioning . Secondary outcomes included fatigue , sleep , anxiety and depressive symptoms , and a patient global impression of improvement . Individuals assigned to the WEB‐SM condition reported significantly greater improvement in pain , physical functioning , and overall global improvement . Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period . A no‐contact , Internet‐based , self‐management intervention demonstrated efficacy on key outcomes for FM . While not everyone is expected to benefit from this approach , this study demonstrated that non‐pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes Introduction No r and omised , controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising ( PC ) in patients with fibromyalgia . Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy ( CBT ) and the recommended pharmacological treatment ( RPT ) compared with treatment as usual ( TAU ) at the primary care level for the treatment of PC in fibromyalgia patients . Methods We conducted a six-month , multicenter , r and omized , blinded , parallel group , controlled trial in which patients were r and omly assigned to one of three study arms : CBT ( n = 57 ) , RPT ( n = 56 ) and TAU at the primary care level ( n = 56 ) . The major outcome of this study was PC in patients with fibromyalgia .  The secondary variables were pain acceptance , depression , anxiety , pain , global function and quality of life . Results CBT significantly decreased global PC at the six-month follow-up examination with effect sizes of Cohen 's d = 0.73 and 1.01 compared with RPT and TAU , respectively . CBT was also more effective than RPT and TAU at increasing pain acceptance at the six-month follow-up examination ( effect sizes of Cohen 's d = 0.77 and 0.80 , respectively ) . Compared with RPT and TAU , CBT was more effective at improving global function based on the Fibromyalgia Impact Question naire ( six-month effect sizes Cohen 's d = 0.44 and 0.53 , respectively ) and quality of life based on the European Quality of Life Scale ( six-month effect sizes Cohen 's d = 0.11 and 0.40 , respectively ) . There were no differences among the three treatments with regard to pain and depression . Conclusions CBT shows higher efficacy than RPT and TAU not only in key outcomes in FM , such as function and quality of life , but also in relevant mediators of treatment effects , such as pain catastrophising and pain acceptance . Trial registration IS RCT N : IS RCT Abstract In this pilot study , we compare the efficacy for  fibromyalgia  of multimodal cognitive behavioral treatments , with and without hypnosis , with that of a purely pharmacological approach , with a multiple baseline N = 1 design . We r and omly assigned six hospital patients to the three experimental conditions . The results suggest that psychological treatment produces greater symptom benefits than the conventional medical treatment only , especially when hypnosis is added . We conclude that hypnosis may be a useful tool to help people with fibromyalgia manage their symptomatology BACKGROUND Self-management has increasingly been recommended as part of st and ard care for fibromyalgia , a common , poorly understood condition with limited treatment options . Data that assess popular self-management recommendations are scarce . We evaluated and compared the effectiveness of 4 common self-management treatments on function , symptoms , and self-efficacy in women with fibromyalgia . METHODS A total of 207 women with confirmed fibromyalgia were recruited from September 16 , 2002 , through November 30 , 2004 , and r and omly assigned to 16 weeks of ( 1 ) aerobic and flexibility exercise ( AE ) ; ( 2 ) strength training , aerobic , and flexibility exercise ( ST ) ; ( 3 ) the Fibromyalgia Self-Help Course ( FSHC ) ; or ( 4 ) a combination of ST and FSHC ( ST-FSHC ) . The primary outcome was change in physical function from baseline to completion of the intervention . Secondary outcomes included social and emotional function , symptoms , and self-efficacy . RESULTS Improvements in the mean Fibromyalgia Impact Question naire score in the 4 groups were -12.7 for the ST-FSHC group , -8.2 for the AE group , -6.6 for the ST group , and -0.3 for the FSHC group . The ST-FSHC group demonstrated greater improvement than the FSHC group ( mean difference , -12.4 ; 95 % confidence interval [ CI ] , -23.1 to -1.7 ) . The ST-FSHC ( mean difference , 13.6 ; 95 % CI , 2.3 to 24.9 ) and AE ( mean difference , 13.1 ; 95 % CI , 1.6 to 25.6 ) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey . Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC ( 14.8 ) , AE ( 13.2 ) , and ST ( 5.7 ) groups . Social function , mental health , fatigue , depression , and self-efficacy also improved . The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months . CONCLUSIONS Progressive walking , simple strength training movements , and stretching activities improve functional status , key symptoms , and self-efficacy in women with fibromyalgia actively being treated with medication . The benefits of exercise are enhanced when combined with targeted self-management education . Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia Contemporary models of chronic musculoskeletal pain emphasize the critical roles of fear , anxiety , and avoidance as well as biases in attention in the development and maintenance of chronic pain disability . Evidence supports the influence of individual difference variables such as anxiety sensitivity , pain-related anxiety , and catastrophizing on the pain experience and on pain-related attentional biases . Changes in attentional biases have been associated with treatment gains in patients with clinical ly significant anxiety .  The Attentional Modification Paradigm ( AMP ) is a modification of the dot-probe paradigm used to facilitate such changes in attentional biases . Given the relationship between chronic musculoskeletal pain and anxiety , AMP may be effective in reducing pain as well . Participants included persons ( n = 17 ) with fibromyalgia and were r and omly assigned to either an AMP condition or a control condition . The participants completed two 15-minute AMP sessions per week for 4 weeks . Those in the AMP condition reported statistically significant and substantial reductions on several individual difference variables relative to those in the control condition , and a greater proportion experienced clinical ly significant reductions in pain . These preliminary results offer a promising new avenue for treating  chronic musculoskeletal pain  that warrants additional research . Comprehensive results , limitations , and future directions are discussed BACKGROUND Insomnia is common and debilitating to fibromyalgia ( FM ) patients .  Cognitive-behavioral therapy ( CBT ) is effective for many types of patients with insomnia , but has yet to be tested with FM patients . This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms . METHODS This r and omized clinical trial enrolled 47 FM patients with chronic insomnia complaints . The study compared CBT , sleep hygiene ( SH ) instructions , and usual FM care alone . Outcome measures were subjective ( sleep logs ) and objective ( actigraphy ) total sleep time , sleep efficiency , total wake time , sleep latency , wake time after sleep onset , and question naire measures of global insomnia symptoms , pain , mood , and quality of life . RESULTS Forty-two patients completed baseline and continued into treatment . Sleep logs showed CBT-treated patients achieved nearly a 50 % reduction in their nocturnal wake time by study completion , whereas SH therapy- and usual care-treated patients achieved only 20 % and 3.5 % reductions on this measure , respectively . In addition , 8 ( 57 % ) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 ( 17 % ) of 12 SH therapy recipients and 0 % of the usual care group . Comparable findings were noted for similar actigraphic improvement criteria . The SH therapy patients showed favorable outcomes on measures of pain and mental well-being . This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies . CONCLUSIONS Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients . Larger clinical trials of this intervention with FM patients seem warranted OBJECTIVE To analyze the long-term efficacy of 2 interventions for female fibromyalgia ( FM ) patients : 1 ) cognitive-behavioral therapy ( CBT ) , and 2 ) a physical exercise (PE)-based strategy . METHODS We conducted a prospect i ve , long-term , r and omized , parallel clinical trial . The outcome variables are physical activity , aerobic capacity , and results of the Fibromyalgia Impact Question naire ( FIQ ) , Short Form 36 , Beck Anxiety and Depression Inventory , Chronic Pain Self-Efficacy Scale , and Chronic Pain Coping Inventory . All were measured at baseline , posttreatment , 6 months , and 1 year . The duration of both treatments was 8 weeks . RESULTS Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment . All variables measuring functional capacity improved significantly in the PE group , whereas only physical activity of the vertebral column improved in the CBT group . There were no differences in anxiety , depression , and self efficacy after treatment in either group . After 1 year of followup , most of the parameters had returned to baseline values in both groups . However , in the PE group , functional capacity remained significantly better . CONCLUSIONS PE and CBT improve clinical manifestations in FM patients only for short periods of time . Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations OBJECTIVE There are currently no controlled studies of behavioral interventions for juvenile primary fibromyalgia syndrome ( JPFM ) . In this small- sample r and omized study , we tested the efficacy of a behavioral intervention , i.e. , coping skills training ( CST ) , for the treatment of adolescents with JPFM . Outcomes tested in this study were functional disability , pain intensity , pain-coping efficacy , and depressive symptoms . METHODS Thirty patients with JPFM were r and omly assigned to 8 weeks of either CST or self-monitoring . Adolescents in the CST condition received training in active pain-coping techniques , while those in the self-monitoring condition monitored daily pain intensity and sleep quality with no instructions about behavior change . After posttreatment assessment , subjects were crossed over into the opposite treatment arm for 8 weeks ( so that all adolescents eventually received both CST and self-monitoring ) and were reassessed at Week 16 . RESULTS At Week 8 , adolescents in both conditions showed significant decrease in depressive symptoms and functional disability . Those who received CST showed significantly greater ability to cope with pain than those in the self-monitoring condition and a trend toward decreased pain intensity . At Week 16 , adolescents had significantly lower levels of disability and depressive symptoms compared to baseline , but those who received self-monitoring followed by CST seemed to receive the most benefit . CONCLUSION CST can lead to improved functioning among JPFM patients . Although some of the improvement may be due to increased monitoring and attention , CST provides the specific benefit of improving  adolescents ' ability to cope with pain OBJECTIVE To examine the effectiveness of a supervised aerobic exercise program , a self-management education program , and the combination of exercise and education for women with fibromyalgia ( FM ) . METHODS One hundred fifty-two women were r and omized into one of 4 groups : exercise-only , education-only , exercise and education , or control . The duration of the study was 12 weeks . All subjects were analyzed at 3 times : before study , immediately upon completion , and 3 months after completion of the intervention program on measures of disability , self-efficacy , fitness , tender point count , and tender point tenderness .  Of the 152 women , complete data were available for 95 and 69 who complied with the protocol . In order to determine the group time interaction , a 2 way analysis of variance with repeated measures was used for each measure . RESULTS The only significant group time interaction was reported with the compliance analysis for the Self-Efficacy Coping with Other Symptoms subscale and the Six Minute Walk . If the program was followed , the combination of a supervised exercise program and group education provided persons with FM with a better sense of control over their symptoms . Fitness improved in the 2 groups undergoing supervised aerobic exercise programs . However , the improvement in fitness was maintained at followup in the exercise-only group and not the combined group . Conclusion . Subjects receiving the combination of exercise and education and who complied with the treatment protocol improved their perceived ability to cope with other symptoms . In addition , a supervised exercise program increased walking distance at post-test , an increase that was maintained at followup in the exercise-only group . Results demonstrate the challenges with conducting exercise and education studies in persons with FM OBJECTIVE To determine the efficacy of an Internet-based Arthritis Self-Management Program ( ASMP ) as a re source for arthritis patients unable or unwilling to attend small-group ASMPs , which have proven effective in changing health-related behaviors and improving health status measures . METHODS R and omized intervention participants were compared with usual care controls at 6 months and 1 year using repeated- measures analyses of variance . Patients with rheumatoid arthritis , osteoarthritis , or fibromyalgia and Internet and e-mail access ( n = 855 ) were r and omized to an intervention  ( n = 433 ) or  usual care control ( n = 422 ) group . Measures included 6 health status variables ( pain , fatigue , activity limitation , health distress , disability , and self-reported global health ) , 4 health behaviors ( aerobic exercise , stretching and strengthening exercise , practice of stress management , and communication with physicians ) , 5 utilization variables ( physician visits , emergency room visits , chiropractic visits , physical therapist visits , and nights in hospital ) , and self-efficacy . RESULTS At 1 year , the intervention group significantly improved in 4 of 6 health status measures and self-efficacy . No significant differences in health behaviors or health care utilization were found . CONCLUSION The Internet-based ASMP proved effective in improving health status measures at 1 year and is a viable alternative to the small-group ASMP OBJECTIVE To evaluate the efficacy of operant pain treatment for fibromyalgia syndrome ( FMS ) in an inpatient setting . METHODS Sixty-one patients who fulfilled the American College of Rheumatology criteria for FMS were r and omly assigned to the operant pain treatment group ( OTG ; n = 40 ) or a st and ardized medical program with an emphasis on physical therapy ( PTG ; n = 21 ) . Pain assessment s were performed before , immediately after , 6 months after , and 15 months after treatment . RESULTS The OTG patients reported a significant and stable reduction in pain intensity , interference , solicitous behavior of the spouse , medication , pain behaviors , number of doctor visits , and days at a hospital as well as an increase in sleeping time . Sixty-five percent of the OTG compared with none of the patients in the PTG showed clinical ly significant improvement . CONCLUSION These results suggest that operant pain treatment provided in an inpatient setting is an effective treatment for FMS , whereas a purely somatically oriented program may lead to a deterioration of the pain problem OBJECTIVE This r and omized controlled clinical trial evaluates the effectiveness of outpatient group cognitive/educational treatment for patients with the fibromyalgia ( FM ) syndrome . We hypothesized that the combination of group education with cognitive treatment aim ed at developing pain coping skills would be more effective than group education alone . METHODS 131 patients with FM were r and omly assigned to 3 conditions : an experimental condition , which was the combined cognitive/educational intervention ( ECO ) ; an attention control condition consisting of group education plus group discussion ( EDI ) ; and a waiting list control ( WLC ) . For the treatment conditions ECO and EDI , assessment s were made 2 weeks before treatment , at start of treatment , at post-treatment , and at 6 and 12 mo followup . WLC patients received only 3 assessment s. RESULTS There were no pretreatment differences between the groups , or between dropouts and patients who remained in the study . At post-treatment , and compared with the WLC , the ECO patients improved in knowledge about FM ( p = 0.007 ) and pain coping ( p < 0.001 ) . EDI patients improved on pain coping ( p = 0.005 ) and pain control ( p = 0.002 ) . EDI patients reported significantly less fear than ECO patients ( p = 0.005 ) . There were no other differential effects between ECO and EDI at post-treatment or 6 mo or 12 mo followup . Based on the reliability of change index for clinical significance , the relative short term success rates are 6.4 and 18.4 % for ECO and EDI , respectively . CONCLUSION The surplus value of a highly structured , 12 session group cognitive treatment added to group education can not be supported by our study . In EDI , fear reduction might have enhanced pain coping and pain control , while poor compliance , the difficulty of homework assignments , and lack of individual support may have limited the effectiveness of ECO OBJECTIVE To determine the effectiveness of self-management education and physical training in decreasing fibromyalgia ( FMS ) symptoms and increasing physical and psychological well being . METHODS A pretest-posttest control group design was used . Ninety-nine women with FMS were r and omly assigned to 1 of 3 groups ; 86 completed the study . The education only group received a 6-week self-management course . The education plus physical training group received the course and 6 h of training design ed to assist them to exercise independently . The control group got treatment after 3 months . RESULTS The experimental programs had a significant positive impact on quality of life and self-efficacy . Helplessness , number of days feeling bad , physical dysfunction , and pain in the tender points decreased significantly in one or both of the treated groups when retested 6 weeks after the end of the program . Longterm followup of 67 treated subjects showed significant positive changes on the Fibromyalgia Impact Question naire primarily in the physical training group . Among all subjects , 87 % were exercising at least 3 times/week for 20 min or more ; 46 % said they had increased their exercise level since participating in the program ; 70 % were practicing relaxation strategies as needed ; 46 % were working at least half time as opposed to 37 % at pretest . CONCLUSION Self-efficacy of the treated groups was enhanced significantly by the program . Other changes were smaller and more delayed than had been expected . Recommendations for future trials include a longer education program , more vigorous physical training , and longterm followup Objective : To examine the effects of a wellness intervention , Lifestyle Counts , for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours , health-promoting activity and perceived quality of life . Design : A r and omized controlled single-blinded trial with treatment and attention-control groups . Setting : Community in the southwestern United States . Subjects : Convenience sample of 187 women ( 98 treatment , 89 attention control ) with fibromyalgia syndrome ( mean age = 53.08 years , SD 9.86 ) . Intervention : The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks , with goal - setting and telephone follow-up for three months . Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls . Participants were followed for a total of eight months after baseline . Outcome measures : Self-report instruments measuring self-efficacy for health behaviours , health-promotion behaviours and health-related quality of life ( SF-36 and the Fibromyalgia Impact Question naire ) were completed at baseline , two months ( after the classes ) , five months ( after telephone follow-up ) and at eight months . Results : Both groups improved significantly ( P<0.05 ) over time on the measures of self-efficacy , health behaviours , fibromyalgia impact and quality of life . There were significant group × time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management . Conclusions : The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome Sleep disturbances play an important role in the exacerbation of pain and other troubling symptoms reported by patients with fibromyalgia ( FM ) . The objective of this trial was to analyze the efficacy of a cognitive-behavioral therapy for insomnia ( CBT-I ) versus a sleep hygiene ( SH ) education program at improving sleep and other clinical manifestations in FM . Sixty-four FM women with insomnia were r and omly assigned to the CBT-I or the SH groups , and 59 completed the treatments ( 30 in the CBT-I group and 29 in the SH group ) . Participants completed several self-report question naires at pre- , post-treatment and follow-ups . The CBT-I group reported significant improvements at post-treatment in several sleep variables , fatigue , daily functioning , pain catastrophizing , anxiety and depression . The SH group only improved significantly in subjective sleep quality . Patients in the CBT-I group showed significantly greater changes than those in the SH group in most outcome measures . The findings underscore the usefulness of CBT-I in the multidisciplinary management of FM OBJECTIVE Sustained improvement in physical functional status was the primary goal of a brief , 6 session cognitive behavioral therapy ( CBT ) protocol for fibromyalgia ( FM ) . METHODS One hundred forty-five patients with FM were r and omly assigned to either ( 1 ) st and ard medical care that included pharmacological management of symptoms and suggestions for aerobic fitness , or ( 2 ) the same st and ard medical treatment plus 6 sessions of CBT aim ed at improving physical functioning . Outcome measures included the Medical Outcome Study Short Form-36 Physical Component Score and McGill ratings of pain . Outcomes were treated dichotomously using a preestablished criterion for clinical ly significant success based upon the reliability of change index from baseline to one year posttreatment . RESULTS Twenty-five percent of the patients receiving CBT were able to achieve clinical ly meaningful levels of longterm improvement in physical functioning , whereas only 12 % of the patients receiving st and ard care achieved the same level of improvement . There were no lasting differences on pain ratings between groups . CONCLUSION Lasting improvements in physical functioning have been among the most difficult outcomes to obtain in studies of FM . These data suggest that the inclusion of CBT to a st and ard medical regimen for FM can favorably influence physical functioning in a subset of patients Abstract Objective : To examine the effects of abruptly withdrawing  milnacipran during the 2-week discontinuation phase of a study in which FM patients had received 12 weeks of stable-dose treatment with milnacipran at 100 mg/day . Research design and methods : The effects of withdrawing milnacipran were evaluated prospect ively over a 2-week period ( Weeks 12 to 14 ) using a r and omized , placebo-controlled withdrawal design . Patients who had originally received milnacipran 100 mg/d for 12 weeks were re-r and omized to continue milnacipran ( n = 178 ) or switch directly to placebo ( n = 178 ) ; patients originally receiving placebo continued placebo ( n = 359 ) . Clinical trial registration : Clinical strials.gov ( NCT00314249 ) . Main outcome measures : Loss of efficacy was evaluated by mean changes in pain and functional measures and by percentage of composite responders , defined as patients with simultaneous improvements in pain , global status , and physical functioning . Newly emergent adverse events and changes in vital signs were also recorded . Results : Within 2 weeks , patients switched from milnacipran to placebo had greater mean worsening in pain , functioning , and global status measures when compared with patients continuing treatment . In addition , significantly fewer composite responders were found in patients who discontinued active treatment than in patients who continued receiving milnacipran ( 22.0 % vs 32.3 % , p < 0.05 ) . Incidences of newly emergent adverse events were 16.3 % and 18.0 % in patients discontinuing and continuing treatment , respectively . Mean vital sign changes decreased or returned to baseline within 2 weeks of discontinuation . Conclusions : Patients discontinuing milnacipran experienced worsening in multiple efficacy parameters within 2 weeks . Vital sign changes observed with milnacipran during the 12-week stable-dose period decreased or returned to baseline values within 2 weeks after discontinuation of treatment . No new safety concerns were found during this discontinuation period with milnacipran The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating Objectives : There is evidence that education on pain physiology can have positive effects on pain , disability , and catastrophization in patients with chronic musculoskeletal pain disorders . A double-blind r and omized controlled trial ( RCT ) was performed to examine whether intensive pain physiology education is also effective in fibromyalgia ( FM ) patients , and whether it is able to influence the impaired endogenous pain inhibition of these patients . Methods : Thirty FM patients were r and omly allocated to either the experimental ( receiving pain physiology education ) or the control group ( receiving pacing self-management education ) . The primary outcome was the efficacy of the pain inhibitory mechanisms , which was evaluated by spatially accumulating thermal nociceptive stimuli . Secondary outcome measures included pressure pain threshold measurements and question naires assessing pain cognitions , behavior , and health status . Assessment s were performed at baseline , 2 weeks , and 3 months follow-up . Repeated measures ANOVAS were used to reveal possible therapy effects and effect sizes were calculated . Results : After the intervention the experimental group had improved knowledge of pain neurophysiology ( P<0.001 ) . Patients from this group worried less about their pain in the short term ( P=0.004 ) . Long-term improvements in physical functioning ( P=0.046 ) , vitality ( P=0.047 ) , mental health ( P<0.001 ) , and general health perceptions ( P<0.001 ) were observed . In addition , the intervention group reported lower pain scores and showed improved endogenous pain inhibition ( P=0.041 ) compared with the control group . Discussion : These results suggest that FM patients are able to underst and and remember the complex material about pain physiology . Pain physiology education seems to be a useful component in the treatment of FM patients as it improves health status and endogenous pain inhibition in the long term BACKGROUND The clinical impact of telephone-delivered cognitive behavioral therapy ( TCBT ) , exercise , or a combined intervention in primary care patients with chronic widespread pain ( CWP ) is unclear . METHODS A total of 442 patients with CWP ( meeting the American College of Rheumatology criteria ) were r and omized to receive 6 months of TCBT , grade d exercise , combined intervention , or treatment as usual ( TAU ) . The primary outcome , using a 7-point patient global assessment scale of change in health since trial enrollment ( range : very much worse to very much better ) , was assessed at baseline and 6 months ( intervention end ) and 9 months after r and omization . A positive outcome was defined as " much better " or " very much better . " Data were analyzed using logistic regression according to the intention-to-treat principle . RESULTS The percentages reporting a positive outcome at 6 and 9 months , respectively , were TAU group , 8 % and 8 % ; TCBT group , 30 % and 33 % ; exercise group , 35 % and 24 % ; and combined intervention group , 37 % and 37 % ( P < .001 ) . After adjustment for age , sex , center , and baseline predictors of outcome , active interventions improved outcome compared with TAU : TCBT ( 6 months : odds ratio [ OR ] , 5.0 [ 95 % CI , 2.0 - 12.5 ] ; 9 months : OR , 5.4 [ 95 % CI , 2.3 - 12.8 ] ) , exercise ( 6 months : OR , 6.1 [ 95 % CI , 2.5 - 15.1 ] ; 9 months : OR , 3.6 [ 95 % CI , 1.5 - 8.5 ] ) , and combined intervention ( 6 months : OR , 7.1 [ 95 % CI , 2.9 - 17.2 ] ; 9 months : OR , 6.2 [ 95 % CI , 2.7 - 14.4 ] ) . At 6 and 9 months , combined intervention was associated with improvements in the 36-Item Short Form Health Question naire physical component score and a reduction in passive coping strategies . Conclusions on cost-effectiveness were sensitive to missing data . CONCLUSION TCBT was associated with substantial , statistically significant , and sustained improvements in patient global assessment . TRIAL REGISTRATION clinical trials.gov Identifier : IS RCT N67013851 UNLABELLED This study compared the efficacy of 2 psychological treatments for fibromyalgia with each other and with st and ard care . Ninety-three patients with fibromyalgia ( FM ) were r and omly assigned to 1 of the 3 experimental conditions : 1 ) multicomponent cognitive-behavioral therapy ( CBT ) ; 2 ) multicomponent CBT with hypnosis ; and 3 ) pharmacological treatment ( st and ard care control group ) . The outcome measures of pain intensity , catastrophizing , psychological distress , functionality , and sleep disturbances were assessed before treatment , immediately after treatment , and at 3- and 6-month follow-up visits . CBT and CBT with hypnosis participants received the st and ard pharmacological management plus 14 weekly , 120-minute-long sessions of psychological treatment . All but 1 session followed a group format ; the remaining session was individual . The analyses indicated that : 1 ) patients with FM who received multicomponent CBT alone or multicomponent CBT with hypnosis showed greater improvements than patients who received only st and ard care ; and 2 ) adding hypnosis enhanced the effectiveness of multicomponent CBT . This study presents new evidence about the efficacy of multicomponent CBT for FM and about the additional effects of hypnosis as a complement to CBT . The relevance and implication s of the obtained results are discussed . PERSPECTIVE This article highlights the beneficial effects of adding hypnosis in a multicomponent cognitive-behavioral group treatment of fibromyalgia patients . Also , this research showed that by adding hypnosis the length of treatment did not increase OBJECTIVE To predict the effects of cognitive-behavioral therapy ( CBT ) and operant-behavioral therapy ( OBT ) in fibromyalgia syndrome ( FMS ) . METHODS A total of 125 patients who fulfilled the American College of Rheumatology FMS criteria were r and omly assigned to CBT ( n = 42 ) , OBT ( n = 43 ) , or attention placebo ( AP ; n = 40 ) . The pretreatment to 12-month followup reliability change index was used to determine clinical ly meaningful changes in pain intensity and physical impairment . Multinominal logistic regression analyses were used to determine the predictors of improvement in pain intensity and physical impairment for the entire sample . Analyses of variance were computed to compare the characteristics of responders and nonresponders in each of the 3 interventions . RESULTS At the 12-month followup , 53.5 % , 45.2 % , and 5 % of patients in the OBT , CBT , and AP groups , respectively , reported clinical ly meaningful improvements in pain intensity . Similarly , 58.1 % , 38.1 % , and 7.5 % of patients treated with OBT , CBT , and AP , respectively , reported clinical ly significant improvements in physical impairment . Prior to treatment , the OBT physical impairment responders displayed significantly more pain behaviors , physical impairment , physician visits , solicitous spouse behaviors , and level of catastrophizing compared with nonresponders . The CBT physical impairment responders , compared with nonresponders , reported higher levels of affective distress , lower coping , less solicitous spouse behavior , and lower pain behaviors . CONCLUSION The results of this study suggest that pretreatment patient characteristics are important predictors of treatment response and may serve as a basis for matching treatments to patient characteristics . Prospect i ve outcome studies are needed to confirm whether the tailoring of treatment actually leads to better outcomes for patients with FMS
target: CBTs provided a small incremental benefit over control interventions in reducing pain , negative mood and disability at the end of treatment and at long-term follow-up .
  The dropout rates due to any reason did not differ between CBTs and controls
background: BACKGROUND Fibromyalgia ( FM ) is a clinical ly well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances , cognitive dysfunction and fatigue .
  Patients often report high disability levels and negative mood .
  Psychotherapies focus on reducing key symptoms , improving daily functioning , mood and sense of personal control over pain .
  OBJECTIVES To assess the benefits and harms of cognitive behavioural therapies ( CBTs ) for treating FM at end of treatment and at long-term ( at least six months ) follow-up .