Dataset Information

Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults With Body Dysmorphic Disorder: A Randomized Clinical Trial.

ABSTRACT:

Importance

Cognitive behavioral therapy (CBT), the best-studied treatment for body dysmorphic disorder (BDD), has to date not been compared with therapist-delivered supportive psychotherapy, the most commonly received psychosocial treatment for BDD.

Objective

To determine whether CBT for BDD (CBT-BDD) is superior to supportive psychotherapy in reducing BDD symptom severity and associated BDD-related insight, depressive symptoms, functional impairment, and quality of life, and whether these effects are durable.

Design, setting, and participants

This randomized clinical trial conducted at Massachusetts General Hospital and Rhode Island Hospital recruited adults with BDD between October 24, 2011, and July 7, 2016. Participants (n = 120) were randomized to the CBT-BDD arm (n = 61) or the supportive psychotherapy arm (n = 59). Weekly treatments were administered at either hospital for 24 weeks, followed by 3- and 6-month follow-up assessments. Measures were administered by blinded independent raters. Intention-to-treat statistical analyses were performed from February 9, 2017, to September 22, 2018.

Interventions

Cognitive behavioral therapy for BDD, a modular skills-based treatment, addresses the unique symptoms of the disorder. Supportive psychotherapy is a nondirective therapy that emphasizes the therapeutic relationship and self-esteem; supportive psychotherapy was enhanced with BDD-specific psychoeducation and treatment rationale.

Main outcomes and measures

The primary outcome was BDD symptom severity measured by the change in score on the Yale-Brown Obsessive-Compulsive Scale Modified for BDD from baseline to end of treatment. Secondary outcomes were the associated symptoms and these were assessed using the Brown Assessment of Beliefs Scale, Beck Depression Inventory-Second Edition, Sheehan Disability Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form.

Results

Of the 120 participants, 92 (76.7%) were women, with a mean (SD) age of 34.0 (13.1) years. The difference in effectiveness between CBT-BDD and supportive psychotherapy was site specific: at 1 site, no difference was detected (estimated mean [SE] slopes, -18.6 [1.9] vs -16.7 [1.9]; P = .48; d growth-modeling analysis change, -0.25), whereas at the other site, CBT-BDD led to greater reductions in BDD symptom severity, compared with supportive psychotherapy (estimated mean [SE] slopes, -18.6 [2.2] vs -7.6 [2.0]; P < .001; d growth-modeling analysis change, -1.36). No posttreatment symptom changes were observed throughout the 6 -months of follow-up (all slope P ≥ .10).

Conclusions and relevance

Body dysmorphic disorder severity and associated symptoms appeared to improve with both CBT-BDD and supportive psychotherapy, although CBT-BDD was associated with more consistent improvement in symptom severity and quality of life.

Trial registration

ClinicalTrials.gov identifier: NCT01453439.

SUBMITTER: Wilhelm S

PROVIDER: S-EPMC6450292 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceSocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited.ObjectiveTo assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT).Design, setting, and participantsThis single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study.InterventionsICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.Main outcomes and measuresThe Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs.ResultsOf the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.Trial registrationClinicalTrials.gov Identifier: NCT03247075.

Project description:BACKGROUND:Body dysmorphic disorder (BDD) is a prevalent and disabling preoccupation with a slight or imagined defect in appearance. Trials have investigated the use of serotonin reuptake inhibitors (SRIs) and cognitive behaviour therapy (CBT) for BDD. OBJECTIVES:To assess the efficacy of pharmacotherapy, psychotherapy or a combination of both treatment modalities for body dysmorphic disorder. SEARCH STRATEGY:We searched the Cochrane Depression, Anxiety and Neurosis Trial Register (December 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2007), MEDLINE (January 1966 to December 2007), and PsycINFO (1967 to December 2007). Ongoing and unpublished trials were located through searching the metaRegister of Controlled Trials, the CRISP and WHO ICTRP search portals (databases searched in December 2007), and through contacting key researchers and pharmaceutical companies. Additional studies were located through study reference lists. SELECTION CRITERIA:Randomised controlled trials (RCTs) of patients meeting DSM or ICD diagnostic criteria for BDD, in which the trials compare pharmacotherapy, psychotherapy or multi-modal treatment groups with active or non-active control groups. Short or long-term trials were eligible. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed RCTs for inclusion in the review, collated trial data, and assessed trial quality. Investigators were contacted to obtain missing data. Summary effect sizes for dichotomous and continuous outcomes were calculated using a random effects model and heterogeneity was assessed. MAIN RESULTS:Two pharmacotherapy and three psychotherapy trials were eligible for inclusion in the review, with data from four short-term RCTs (169 participants) available for analysis. Response data from a single placebo-controlled trial of fluoxetine suggested overall superiority of medication relative to placebo (relative risk (RR) 3.07, 95% CI 1.4 to 6.72, n = 67). Symptom severity was also significantly reduced in the RCTs of fluoxetine and clomipramine (relative to desipramine), as well as in the two CBT trials (WMD -44.96, 95% CI -54.43 to -35.49, n = 73). A low relapse rate (4/22) was demonstrated in one trial of CBT. AUTHORS' CONCLUSIONS:Results from the small number of available RCTs suggest that SRIs and CBT may be useful in treating patients with BDD. The findings of these studies need to be replicated. In addition, future controlled studies in other samples, such as adolescents, and using other selective SRIs, as well as a range of psychological therapy approaches and modalities (alone and in combination), are essential in supplementing the sparse data currently available.

Project description:ObjectivesTo evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy.DesignA 12 week single blind parallel group randomised controlled trial.SettingAcademic medical centre.Participants94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial.InterventionsParticipants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks.Main outcome measuresThe primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial.ResultsBDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high.ConclusionsCBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide.Trial registration ClinicalTrials.gov ID: NCT02010619.

Project description:ObjectivesCognitive-behavioural therapy (CBT) is an effective treatment for body dysmorphic disorder (BDD). However, most sufferers do not have access to this treatment. One way to increase access to CBT is to administer treatment remotely via the Internet. This study piloted a novel therapist-supported, Internet-based CBT program for BDD (BDD-NET).DesignUncontrolled clinical trial.ParticipantsPatients (N=23) were recruited through self-referral and assessed face to face at a clinic specialising in obsessive-compulsive and related disorders. Suitable patients were offered secure access to BDD-NET.InterventionBDD-NET is a 12-week treatment program based on current psychological models of BDD that includes psychoeducation, functional analysis, cognitive restructuring, exposure and response prevention, and relapse prevention modules. A dedicated therapist provides active guidance and feedback throughout the entire process.Main outcome measureThe clinician-administered Yale-Brown Obsessive Compulsive Scale for BDD (BDD-YBOCS). Symptom severity was assessed pretreatment, post-treatment and at the 3-month follow-up.ResultsBDD-NET was deemed highly acceptable by patients and led to significant improvements on the BDD-YBOCS (p=<0.001) with a large within-group effect size (Cohen's d=2.01, 95% CI 1.05 to 2.97). At post-treatment, 82% of the patients were classified as responders (defined as≥30% improvement on the BDD-YBOCS). These gains were maintained at the 3-month follow-up. Secondary outcome measures of depression, global functioning and quality of life also showed significant improvements with moderate to large effect sizes. On average, therapists spent 10 min per patient per week providing support.ConclusionsThe results suggest that BDD-NET has the potential to greatly increase access to CBT, at least for low-risk individuals with moderately severe BDD symptoms and reasonably good insight. A randomised controlled trial of BDD-NET is warranted.Trial registration numberClinicaltrials.gov registration ID NCT01850433.

Project description:BackgroundSmartphone-delivered cognitive behavioral therapy (CBT) is becoming more common, but research on the topic remains in its infancy. Little is known about how people typically engage with smartphone CBT or which engagement and mobility patterns may optimize treatment. Passive smartphone data offer a unique opportunity to gain insight into these knowledge gaps.ObjectiveThis study aimed to examine passive smartphone data across a pilot course of smartphone CBT for body dysmorphic disorder (BDD), a psychiatric illness characterized by a preoccupation with a perceived defect in physical appearance, to inform hypothesis generation and the design of subsequent, larger trials.MethodsA total of 10 adults with primary diagnoses of BDD were recruited nationally and completed telehealth clinician assessments with a reliable evaluator. In a 12-week open pilot trial of smartphone CBT, we initially characterized natural patterns of engagement with the treatment and tested how engagement and mobility patterns across treatment corresponded with treatment response.ResultsMost participants interacted briefly and frequently with smartphone-delivered treatment. More frequent app usage (r=-0.57), as opposed to greater usage duration (r=-0.084), correlated strongly with response. GPS-detected time at home, a potential digital marker of avoidance, decreased across treatment and correlated moderately with BDD severity (r=0.49).ConclusionsThe sample was small in this pilot study; thus, results should be used to inform the hypotheses and design of subsequent trials. The results provide initial evidence that frequent (even if brief) practice of CBT skills may optimize response to smartphone CBT and that mobility patterns may serve as useful passive markers of symptom severity. This is one of the first studies to examine the value that passively collected sensor data may contribute to understanding and optimizing users' response to smartphone CBT. With further validation, the results can inform how to enhance smartphone CBT design.

Project description:ObjectivesCognitive behavioral therapy (CBT) is the most promising treatment for gambling disorder (GD) but only 21% of those with problematic gambling seek treatment. CBT over the Internet might be one way to reach a larger population. The aim of this study was to assess the effectiveness of Internet-delivered CBT with therapist guidance compared to an active control treatment.MethodsUsing a single-blinded design, 71 treatment-seeking gamblers (18-75 years) diagnosed with GD were randomized to 8 weeks of Internet-delivered CBT guided by telephone support, or 8 weeks of Internet-delivered motivational enhancement paired with motivational interviewing via telephone (IMI). The primary outcome was gambling symptoms measured at a first face-to-face assessment, baseline (treatment start), every 2 weeks, post-treatment, and 6-month follow-up. Gambling expenditures, time spent gambling, depression, anxiety, cognitive distortions, and quality of life were assessed as secondary outcomes. Analysis was performed on the full analysis sample (n = 60), with intention-to-treat sensitivity analyses (n = 69).ResultsIn the CBT group, 80% stayed in treatment until the final week, compared to 67% in IMI. Post-treatment and at 6-month follow-up, no differences were found between CBT and IMI for any outcome measure. An exploratory analysis of the total sample (n = 60) showed a significant effect of time during treatment on gambling symptoms (d, [95% CI] 0.52, [-1.15, 2.02]) and all secondary outcomes except the gambling diary (depression (0.89, [-1.07-2.65]); anxiety (0.69, [-1.20-2.38])); cognitive distortions (0.84, [-0.73-2.29]); quality of life (0.60, [-0.61-1.70])). Post-treatment, there were no clinical gambling symptoms in either group. Some deterioration was seen between post-treatment and 6-month follow-up on gambling symptoms (0.42, [-1.74-2.43]), depression (0.59, [-0.82-1.86]), and anxiety (0.30, [-0.99-1.48]). Additionally, it was observed that the largest reduction in gambling symptoms was between the first assessment and baseline.ConclusionBoth treatments offered in this study were effective at reducing gambling symptoms. It is also possible that the process of change started before treatment, which gives promise to low-intensity interventions for GD. Additional research is needed as this approach could be both cost-effective and has the potential to reach more patients in need of treatment than is currently possible.Clinical trial registrationhttps://www.isrctn.com/, identifier ISRCTN38692394.