An interventional study of App-Based Cognitive Behavioral Therapy in Body Dysmorphic Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-26.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.
The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.
This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 10 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1B (open pilot trial):
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12-week Smartphone-delivered CBT for BDD.
Behavioral: App-Based Cognitive Behavioral Therapy
12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
Treatment Completion Rates
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Time frame: Post treatment assessment (12 weeks)
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame: Post-treatment assessment (week 12)
Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint.
Time frame: Post-treatment assessment (week 12)
| Milestone | App-Based Cognitive Behavioral Therapy |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
| Participants | App-Based Cognitive Behavioral Therapy |
|---|---|
| Treatment Completion Rates | 10 |
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
| score on a scale | App-Based Cognitive Behavioral Therapy |
|---|---|
| Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total). | 27.90 ± 3.51 |
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint.
| score on a scale | App-Based Cognitive Behavioral Therapy |
|---|---|
| Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total). | 16.50 ± 3.63 |
Collected over Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| App-Based Cognitive Behavioral Therapy | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Event | App-Based Cognitive Behavioral Therapy |
|---|---|
| Depressive symptomsPsychiatric disorders | 3/10 |
| Increased stress/anxietyPsychiatric disorders | 2/10 |
| Pap smearReproductive system and breast disorders | 1/8 |
| Delayed menstrual cycleReproductive system and breast disorders | 1/8 |
| Urinary tract infectionInfections and infestations | 1/10 |
| Breast lump examinationReproductive system and breast disorders | 1/10 |
| Wisdom teeth removalGeneral disorders | 1/10 |
| Age, Continuous(years) | App-Based Cognitive Behavioral Therapy |
|---|---|
| Mean | 27.6 ± 5.66 |
| Sex: Female, Male(Participants) | App-Based Cognitive Behavioral Therapy |
|---|---|
| Female | 8 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | App-Based Cognitive Behavioral Therapy |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | App-Based Cognitive Behavioral Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 8 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2017 to primary completion in Jan 2019, 17 months.
Results were first posted in Jun 2019, 5 months after primary completion.
Of 26 interventional studies with no phase under Body Dysmorphic Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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