An interventional study of Cognitive Behavioral Therapy and Supportive Psychotherapy in Body Dysmorphic Disorder, Obsessive-Compulsive Spectrum Disorder and Anxiety Disorders, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to learn more about two different types of psychotherapy to help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and common disorder consisting of distressing or impairing preoccupation with perceived defects in one's physical appearance. Individuals with BDD have very poor psychosocial functioning and high rates of hospitalization and suicidality. Because BDD differs in important ways from other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy and Supportive Psychotherapy as well as predictors of improvement.
Body Dysmorphic Disorder (BDD) is a common and severe disorder in which a person is preoccupied by perceived defects in his or her appearance. The purpose of this research study is to learn more about two different forms of therapy to help individuals with BDD: cognitive behavioral therapy (CBT), a promising new treatment for BDD, and supportive psychotherapy (SPT), the most commonly received therapy for BDD. The investigators would like to find out which treatment is more effective for BDD. The investigators will also examine patient characteristics that may predict response to treatment.
Participants will be randomly assigned (like the flip of a coin) to receive 22 sessions (over 24 weeks) of either CBT or SPT. Both treatments teach participants about BDD. CBT focuses on helping participants to develop more adaptive thoughts and beliefs and to gradually reduce avoidance and compulsive (repetitive) behaviors. SPT focuses on relationships, feelings, and other factors that may affect BDD symptoms (e.g., work, stress), and helps participants to cope with challenges in their life by improving self-esteem and positive coping.
For each participant, this study will last for 12 months. CBT and SPT sessions occur for 22 sessions over 24 weeks. The severity of participants' BDD-related symptoms and other symptoms will be assessed at the end of treatment (week 24), and at 3- and 6-months after treatment ends.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 120 is above 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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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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
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Group receiving Cognitive-Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy
Group receiving Supportive Psychotherapy
Behavioral: Supportive Psychotherapy
Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based CBT. During the sessions, participants will receive education about BDD and CBT, learn to develop more helpful thoughts and beliefs, gradually enter anxiety provoking situations while reducing compulsions (repetitive behaviors), and learn relapse prevention techniques.
Also known as: CBT
Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based SPT. During the sessions, participants will receive education about BDD and SPT, learn about factors that may affect their symptoms (for example, relationships, work, stress), and learn to cope with challenges in their life by improving self-esteem and positive coping skills.
Also known as: SPT
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Time frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.
Insight Regarding BDD Beliefs (as Measured by the BABS)
The Brown Assessment of Beliefs Scale (BABS) is a 7-item, semi-structured, clinician-administered measure that was used to assess insight regarding BDD-related beliefs (e.g., "I look deformed"). The first six items of the BABS were summed to obtain a total score ranging from 0 to 24, with higher scores reflecting poorer insight. Treatment effects on BABS score were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Time frame: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
Depressive Symptoms (as Measured by the BDI-II)
The Beck Depression Inventory-Second Edition (BDI-II) is a widely used 21-item self-report scale that assesses the severity of depressive symptoms during the past 2 weeks. Total scale scores range from 0 to 63, with higher scores indicating greater symptom severity. Treatment effects on depression were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Time frame: Measured every week during treatment, but analysis was performed only on BDI-II assessments close to assessment visits; wk 0, 4, 8, 12, 16, 20 and 24. Followup phase data was measured at week 37 and week 50.
Life Satisfaction (Q-LESQ-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Questions 1-14 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the % score range is 0% to 100%, with higher scores indicating greater quality of life. Treatment effects on life satisfaction were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Time frame: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.
Treatment Credibility (Credibility/Expectancy Rating Scale)
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment credibility is based on the mean score of the first three items, which are measured on 10-point Likert scales, so that mean scores range from 1 (lowest/worst) to 10 (highest/most). Treatment credibility was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Beliefs About Appearance (as Measured by the ASI-R)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Neuropsychological Functioning (as Measured by the ROCF)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Information Processing (as Measured by the ERT)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) is a 5-item self-report measure of functional impairment/disability. Items 1-3 (disability in work, social life/leisure, and family life/home responsibilities, respectively) are scored on Likert-scales that range from 0 (not at all) to 10 (extreme). The three items are then summed to yield an SDS total score, ranging from 0 (unimpaired) to 30 (highly impaired). Treatment effects on functional impairment were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Time frame: Measured at baseline, week 4, week 12, week 16, and week 24. Follow-up phase data was measured at week 37 and at week 50.
Treatment Satisfaction (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire that assesses satisfaction with clinical services received and has a score range of 8-32, where higher scores indicate higher satisfaction.
Time frame: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
Treatment Expectancy (Credibility/Expectancy Rating Scale)
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment expectancy is a single item rating of "By the end of therapy, how much improvement in your anxiety do you think will occur?", rated on a scale from 0% to 100%. It was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
| Milestone | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Started | 61 | 59 |
| Completed | 44 | 48 |
| Not completed | 17 | 11 |
| Withdrew: Withdrawal by subject | 13 | 10 |
| Withdrew: Suicidal ideation | 2 | 0 |
| Withdrew: Need for higher level of care | 1 | 1 |
| Withdrew: Therapist conflict of interest | 1 | 0 |
| Milestone | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Started | 44 | 48 |
| Completed | 39 | 37 |
| Not completed | 5 | 11 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 5 | 10 |
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
| score on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Baseline | 32.21 ± 4.72 | 31.49 ± 4.94 |
| Week 4 | 26.92 ± 6.20 | 27.27 ± 6.41 |
| Week 8 | 24.34 ± 7.70 | 25.09 ± 7.57 |
| Week 12 | 19.67 ± 8.21 | 22.80 ± 8.90 |
| week 16 | 17.74 ± 9.21 | 22.13 ± 9.33 |
| Week 20 | 15.95 ± 9.32 | 19.02 ± 9.44 |
| Week 24 | 13.34 ± 9.46 | 18.67 ± 9.77 |
| Week 37 | 12.30 ± 9.84 | 17.46 ± 9.81 |
| Week 50 | 12.31 ± 10.75 | 16.90 ± 10.94 |
The Brown Assessment of Beliefs Scale (BABS) is a 7-item, semi-structured, clinician-administered measure that was used to assess insight regarding BDD-related beliefs (e.g., "I look deformed"). The first six items of the BABS were summed to obtain a total score ranging from 0 to 24, with higher scores reflecting poorer insight. Treatment effects on BABS score were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
| units on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Baseline | 17.2459016 ± 4.2608909 | 15.4067797 ± 4.1817281 |
| Week 4 | 14.7500000 ± 5.2538501 | 13.3090909 ± 5.0584463 |
| Week 8 | 14.5128205 ± 5.9066056 | 12.8500000 ± 5.0765928 |
| Week 12 | 10.8837209 ± 5.8562515 | 11.1304348 ± 6.0428422 |
| week 16 | 10.8571429 ± 7.2769983 | 9.7608696 ± 5.3465868 |
| Week 20 | 9.8461538 ± 6.5435322 | 10.0277778 ± 5.8235292 |
| Week 24 | 8.3636364 ± 7.5823875 | 7.9791667 ± 5.8908136 |
| Week 37 | 6.6279070 ± 7.0000791 | 8.3170732 ± 5.8199614 |
| Week 50 | 7.1578947 ± 7.9679300 | 7.3783784 ± 5.7848046 |
The Beck Depression Inventory-Second Edition (BDI-II) is a widely used 21-item self-report scale that assesses the severity of depressive symptoms during the past 2 weeks. Total scale scores range from 0 to 63, with higher scores indicating greater symptom severity. Treatment effects on depression were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
| units on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Baseline | 22.1639344 ± 13.1923972 | 22.8620690 ± 13.6117187 |
| Week 4 | 18.6923077 ± 11.7215044 | 21.4035088 ± 14.9938793 |
| Week 8 | 16.9591837 ± 13.4953066 | 19.3076923 ± 14.3178737 |
| Week 12 | 15.2000000 ± 13.1037815 | 19.6041667 ± 14.8563900 |
| week 16 | 13.4000000 ± 12.9446374 | 17.5416667 ± 15.3220163 |
| Week 20 | 11.4545455 ± 11.3474811 | 15.9302326 ± 14.2300744 |
| Week 24 | 10.5348837 ± 12.2966291 | 15.6041667 ± 14.2541365 |
| Week 37 | 9.2307692 ± 11.4120470 | 12.8611111 ± 13.9328036 |
| Week 50 | 12.0606061 ± 15.3030622 | 13.6666667 ± 13.6541855 |
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Questions 1-14 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the % score range is 0% to 100%, with higher scores indicating greater quality of life. Treatment effects on life satisfaction were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
| units on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Baseline | 48.7500000 ± 15.0603393 | 50.6961259 ± 16.6428814 |
| Week 4 | 49.6648352 ± 15.8763522 | 51.7857143 ± 18.0729259 |
| Week 12 | 61.0119048 ± 17.3217504 | 57.6190476 ± 17.6382690 |
| Week 16 | 60.8894231 ± 15.9117634 | 57.3457792 ± 19.9192124 |
| week 24 | 68.2055749 ± 19.3905036 | 63.9437690 ± 19.0175684 |
| Week 37 | 69.1849817 ± 17.5141781 | 64.3339768 ± 17.0683239 |
| Week 50 | 66.5095899 ± 21.2768017 | 65.8928571 ± 19.3884669 |
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment credibility is based on the mean score of the first three items, which are measured on 10-point Likert scales, so that mean scores range from 1 (lowest/worst) to 10 (highest/most). Treatment credibility was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
| score on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Week 0 | 7.10 ± 1.79 | 6.64 ± 1.84 |
| Week 4 | 7.19 ± 1.68 | 6.28 ± 1.84 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
The Sheehan Disability Scale (SDS) is a 5-item self-report measure of functional impairment/disability. Items 1-3 (disability in work, social life/leisure, and family life/home responsibilities, respectively) are scored on Likert-scales that range from 0 (not at all) to 10 (extreme). The three items are then summed to yield an SDS total score, ranging from 0 (unimpaired) to 30 (highly impaired). Treatment effects on functional impairment were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
| score on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Baseline | 16.3333333 ± 5.5621806 | 17.4406780 ± 6.0522757 |
| Week 4 | 15.1000000 ± 6.3927574 | 15.5000000 ± 7.0056000 |
| Week 12 | 11.7142857 ± 7.4023257 | 12.2222222 ± 7.8534558 |
| Week 16 | 9.7250000 ± 7.6660674 | 11.7272727 ± 8.2019953 |
| week 24 | 7.9024390 ± 8.2970021 | 9.0869565 ± 7.2105666 |
| Week 37 | 6.4871795 ± 6.3613628 | 9.2162162 ± 7.7428646 |
| Week 50 | 6.6388889 ± 8.1980931 | 8.3666667 ± 7.8013409 |
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire that assesses satisfaction with clinical services received and has a score range of 8-32, where higher scores indicate higher satisfaction.
| score on a scale | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Week 12 | 28.02 ± 2.88 | 26.60 ± 3.82 |
| Week 24 | 29.40 ± 3.56 | 27.56 ± 4.07 |
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment expectancy is a single item rating of "By the end of therapy, how much improvement in your anxiety do you think will occur?", rated on a scale from 0% to 100%. It was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
| Percent improvement expected (0-100%) | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Week 0 | 58.36 ± 20.71 | 50.19 ± 19.28 |
| Week 4 | 56.00 ± 20.40 | 46.73 ± 20.55 |
Collected over Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 weeks prior).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | 0/61 (0%) | 5/61 (8.2%) | 34/61 (55.7%) |
| Supportive Psychotherapy (SPT) | 0/59 (0%) | 3/59 (5.1%) | 30/59 (50.8%) |
| Event | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 1/61 | 1/59 |
| MononucleosisInfections and infestations | 0/61 | 1/59 |
| Anaphylactic shockImmune system disorders | 0/61 | 1/59 |
| Increase in BDD and depressive SymptomsPsychiatric disorders | 1/61 | 0/59 |
| Self-harmPsychiatric disorders | 1/61 | 0/59 |
| Negative reaction to anesthesiaGastrointestinal disorders | 1/61 | 0/59 |
| Pain felt in one arm for a couple of daysGeneral disorders | 1/61 | 0/59 |
| Cardiac surgeryCardiac disorders | 1/61 | 0/59 |
| Event | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) |
|---|---|---|
| Increased anxiety and/or depressionPsychiatric disorders | 8/61 | 13/59 |
| Injury, poisoning, and procedural complicationsInjury, poisoning and procedural complications | 9/61 | 5/59 |
| Increase in other psychiatric symptomsPsychiatric disorders | 8/61 | 3/59 |
| Surgical and medical proceduresSurgical and medical procedures | 2/61 | 4/59 |
| Suicidal ideation and/or self-harmPsychiatric disorders | 4/61 | 1/59 |
| Nervous system disordersNervous system disorders | 4/61 | 3/59 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 2/61 | 3/59 |
| Social circumstancesSocial circumstances | 2/61 | 3/59 |
| Age, Continuous(years) | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) | Total |
|---|---|---|---|
| Mean | 34.5 ± 14.5 | 33.4 ± 11.5 | 33.9 ± 12.9 |
| Sex: Female, Male(Participants) | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) | Total |
|---|---|---|---|
| Female | 46 | 46 | 92 |
| Male | 15 | 13 | 28 |
| Race/Ethnicity, Customized(Participants) | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) | Total |
|---|---|---|---|
| White, Non-Hispanic | 47 | 53 | 100 |
| White, Hispanic | 2 | 2 | 4 |
| Black | 1 | 1 | 2 |
| Asian/Pacific Islander | 6 | 1 | 7 |
| Other | 5 | 2 | 7 |
| Region of Enrollment(Participants) | Cognitive Behavior Therapy (CBT) | Supportive Psychotherapy (SPT) | Total |
|---|---|---|---|
| United States | 61 | 59 | 120 |
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