Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH091078 | U.S. NIH Grant/Contract | View source | |
| 2010-P-001021/2 | Other Identifier | Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Group receiving Cognitive-Behavioral Therapy |
|
| Supportive Psychotherapy | Active Comparator | Group receiving Supportive Psychotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Katharine Phillips, M.D. | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Rhode Island Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30785624 | Derived | Wilhelm S, Phillips KA, Greenberg JL, O'Keefe SM, Hoeppner SS, Keshaviah A, Sarvode-Mothi S, Schoenfeld DA. Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults With Body Dysmorphic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Apr 1;76(4):363-373. doi: 10.1001/jamapsychiatry.2018.4156. |
| Label | URL |
|---|---|
| Click here to visit the official website of the Body Dysmorphic Disorder Clinic at MGH | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavior Therapy (CBT) | Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Supportive Psychotherapy | Behavioral | 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. |
|
|
| 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). | 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). | 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. | Measured twice during the study (week 0 [pre-treatment] and at week 4) |
| Beliefs About Appearance (as Measured by the ASI-R) | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) |
| Neuropsychological Functioning (as Measured by the ROCF) | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) |
| Information Processing (as Measured by the ERT) | 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). | 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. | 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. | Measured twice during the study (week 0 [pre-treatment] and at week 4) |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| FG001 |
| Supportive Psychotherapy (SPT) |
SPT is a widely received psychosocial treatment by persons with BDD. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavior Therapy (CBT) | Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD. |
| BG001 | Supportive Psychotherapy (SPT) | SPT is a widely received psychosocial treatment by persons with BDD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Massachusetts General Hospital/Harvard Medical School and Rhode Island Hospital/Brown University will collaboratively recruited 120 adult participants to and were randomly assigned to receive CBT or SPT. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. | Posted | Mean | Standard Deviation | units on a scale | Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. | Posted | Mean | Standard Deviation | units on a scale | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. | Posted | Mean | Standard Deviation | units on a scale | Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population for this analysis was limited to those participants who completed the questionnaire (n=6 missing responses in the CBT arm, n=5 missing responses in the SPT arm at baseline), and decrease by week 4 due to study drop-out or missed assessments. | Posted | Mean | Standard Deviation | score on a scale | Measured twice during the study (week 0 [pre-treatment] and at week 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Beliefs About Appearance (as Measured by the ASI-R) | Not Posted | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Neuropsychological Functioning (as Measured by the ROCF) | Not Posted | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Information Processing (as Measured by the ERT) | Not Posted | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. | Posted | Mean | Standard Deviation | score on a scale | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population for this outcome was limited to those who were still in the study by week 12 (mid-treatmtent) and who completed the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment] |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population for this analysis was limited to those participants who completed the questionnaire (n=6 missing responses in the CBT arm, n=5 missing responses in the SPT arm at baseline), and decrease by week 4 due to study drop-out or missed assessments. | Posted | Mean | Standard Deviation | Percent improvement expected (0-100%) | Measured twice during the study (week 0 [pre-treatment] and at week 4) |
|
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).
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting >5% in either treatment group are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavior Therapy (CBT) | Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD. | 0 | 61 | 5 | 61 | 34 | 61 |
| EG001 | Supportive Psychotherapy (SPT) | SPT is a widely received psychosocial treatment by persons with BDD. | 0 | 59 | 3 | 59 | 30 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Increase in BDD and depressive Symptoms | Psychiatric disorders | Systematic Assessment | Increase in BDD and depressive symptoms and relationship stressors. |
| |
| Self-harm | Psychiatric disorders | Systematic Assessment | The participant cut himself/herself with a box cutter when distressed; was hospitalized. |
| |
| Negative reaction to anesthesia | Gastrointestinal disorders | Systematic Assessment | The participant was hospitalized after a negative reaction to anesthesia. Symptoms included nausea and vomiting. The participant had received anesthesia for a more invasive procedure to address complications from a preexisting cyst. |
| |
| Pain felt in one arm for a couple of days | General disorders | Systematic Assessment | The participant was admitted to an emergency room due to pain felt in one arm for a couple of days and was kept overnight for monitoring and released the next day with no official diagnosis given. |
| |
| Mononucleosis | Infections and infestations | Systematic Assessment | Participant was hospitalized for one night for Mononucleosis (Mono) and was sick for 4 days. |
| |
| Cardiac surgery | Cardiac disorders | Systematic Assessment | Cardiac surgery and recovery. |
| |
| Anaphylactic shock | Immune system disorders | Systematic Assessment | Anaphylactic shock |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased anxiety and/or depression | Psychiatric disorders | Systematic Assessment | Increased depression or anxiety since starting study; no suicidal ideation. |
| |
| Increase in other psychiatric symptoms | Psychiatric disorders | Systematic Assessment | Patients reported isolated occurrences of or temporary increases in other psychiatric symptoms, including obsessive thoughts, BDD symptoms, stress, fatigue, irritability, or binge drinking. |
| |
| Suicidal ideation and/or self-harm | Psychiatric disorders | Systematic Assessment | Occurrences of suicidal ideation or incidents of self-harm (e.g., cutting) |
| |
| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment | AE descriptions included car accidents with minor injuries, broken or fractured bones, concussions, back injuries, accidental cut, ankle sprains, abrasion, alcohol poisoning, shoulder injury, cracked/chipped teeth, food poisoning, heat exhaustion |
| |
| Nervous system disorders | Nervous system disorders | Systematic Assessment | AE descriptions included (flare up of) herniated disks, headaches, migraines, spine troubles, pinched nerve, and sharp pain in head. |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | AE descriptions included flu, concerns about possible lung cancer (not detected), bronchitis, sore throat, and head and chest congestion. |
| |
| Social circumstances | Social circumstances | Systematic Assessment | AE descriptions included friend dying in car crash, family conflict, spouse laid off from work, death of a parent, and hospitalization of a close family member. |
| |
| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment | AE descriptions included minor outpatient surgery to to remove a splinter, cataract surgery, colonoscopy & ultrasound for removal of precancerous cells, scheduled surgeries, and a visit to a chiropractor. |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sabine Wilhelm, Ph.D. | Massachusetts General Hospital | +1(617)724-6146 | swilhelm@mgh.harvard.edu |
| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| D001008 | Anxiety Disorders |
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| Male |
|
| White, Hispanic |
|
| Black |
|
| Asian/Pacific Islander |
|
| Other |
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 37 |
|
|
| Week 50 |
|
|
The estimated value describes the mean slope difference of CBT compared to SPT.
| Superiority |
| We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person. Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments [to be tested]. | Mixed Models Analysis | The effect of interest was the time by group interaction. | .62 | Degrees of freedom=74.7 | Slope | -0.00984 | Standard Error of the Mean | 0.1038 | 2-Sided | The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50). | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|