Anxiety Disorders, Body Dysmorphic Disorder, Obsessive-Compulsive Spectrum Disorder, Somatoform Disorders
Conditions
Keywords
Body dysmorphic disorder, Obsessive compulsive spectrum disorder, Body image, Appearance concerns
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
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.
BEHAVIORALSupportive Psychotherapy
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.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient men and women age 18 and older * DSM-IV BDD or its delusional variant for at least 6 months * BDD is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment * Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
Exclusion criteria
* Current clinically significant suicidality and/or score on the BDI-II suicide item (#9) \> 1 * Any clinical features requiring a higher level of care * Mental retardation or borderline intellectual functioning (estimated IQ \< 80 on the Wechsler Abbreviated Scale of Intelligence) or dementia, brain damage, or other cognitive impairment that would interfere with ability to engage in CBT * DSM-IV substance abuse or dependence within the past 3 months; or a positive urine drug screen for any illicit substances of abuse * Current manic episode * Psychotic disorder * Borderline personality disorder * Body image concerns accounted for by an eating disorder * Previous treatment with \> 10 sessions of CBT for BDD * Subjects cannot be receiving any other psychotherapy or begin such treatment during the study * Patients can be receiving psychotropic medication if they have taken a stable dose for at least two months before the study baseline assessment and the dose remains stable during the study. * Presence of any behavior (e.g., violence) that would interfere with full cooperation with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms (as Measured by the BDI-II) | 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. | 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). |
| Life Satisfaction (Q-LESQ-SF) | Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50. | 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). |
| Treatment Credibility (Credibility/Expectancy Rating Scale) | Measured twice during the study (week 0 [pre-treatment] and at week 4) | 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. |
| 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]) | — |
| Insight Regarding BDD Beliefs (as Measured by the BABS) | Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits | 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). |
| 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) | 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. | 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). |
| Treatment Satisfaction (CSQ-8) | The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment] | 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. |
| Treatment Expectancy (Credibility/Expectancy Rating Scale) | Measured twice during the study (week 0 [pre-treatment] and at week 4) | 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. |
| Neuropsychological Functioning (as Measured by the ROCF) | Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| Supportive Psychotherapy (SPT) SPT is a widely received psychosocial treatment by persons with BDD. | 59 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up | Lost to Follow-up | 5 | 10 |
| Follow-up | Withdrawal by Subject | 0 | 1 |
| Treatment Phase | Need for higher level of care | 1 | 1 |
| Treatment Phase | Suicidal Ideation | 2 | 0 |
| Treatment Phase | Therapist conflict of interest | 1 | 0 |
| Treatment Phase | Withdrawal by Subject | 13 | 10 |
Baseline characteristics
| Characteristic | Supportive Psychotherapy (SPT) | Cognitive Behavior Therapy (CBT) | Total |
|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 11.5 | 34.5 years STANDARD_DEVIATION 14.5 | 33.9 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized White, Hispanic | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 53 Participants | 47 Participants | 100 Participants |
| Region of Enrollment United States | 59 Participants | 61 Participants | 120 Participants |
| Sex: Female, Male Female | 46 Participants | 46 Participants | 92 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 59 |
| other Total, other adverse events | 34 / 61 | 30 / 59 |
| serious Total, serious adverse events | 5 / 61 | 3 / 59 |
Outcome results
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).
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 4 | 26.92 score on a scale | Standard Deviation 6.2 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 20 | 15.95 score on a scale | Standard Deviation 9.32 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 12 | 19.67 score on a scale | Standard Deviation 8.21 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 24 | 13.34 score on a scale | Standard Deviation 9.46 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 8 | 24.34 score on a scale | Standard Deviation 7.7 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 37 | 12.30 score on a scale | Standard Deviation 9.84 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | week 16 | 17.74 score on a scale | Standard Deviation 9.21 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 50 | 12.31 score on a scale | Standard Deviation 10.75 |
| Cognitive Behavior Therapy (CBT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Baseline | 32.21 score on a scale | Standard Deviation 4.72 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 50 | 16.90 score on a scale | Standard Deviation 10.94 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Baseline | 31.49 score on a scale | Standard Deviation 4.94 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 4 | 27.27 score on a scale | Standard Deviation 6.41 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 8 | 25.09 score on a scale | Standard Deviation 7.57 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 12 | 22.80 score on a scale | Standard Deviation 8.9 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | week 16 | 22.13 score on a scale | Standard Deviation 9.33 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 20 | 19.02 score on a scale | Standard Deviation 9.44 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 24 | 18.67 score on a scale | Standard Deviation 9.77 |
| Supportive Psychotherapy (SPT) | Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) | Week 37 | 17.46 score on a scale | Standard Deviation 9.81 |
Comparison: We compared the difference in the rate of change in BDD symptom severity over time (during treatment 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 in the CBT group will not be significantly different from the SPT group \[to be tested\].p-value: <0.01Mixed Models Analysis
Comparison: 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 \[to be tested\].p-value: 0.62Mixed Models Analysis
Secondary
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])
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).
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 4 | 18.6923077 units on a scale | Standard Deviation 11.7215044 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 20 | 11.4545455 units on a scale | Standard Deviation 11.3474811 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 12 | 15.2000000 units on a scale | Standard Deviation 13.1037815 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 24 | 10.5348837 units on a scale | Standard Deviation 12.2966291 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 8 | 16.9591837 units on a scale | Standard Deviation 13.4953066 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 37 | 9.2307692 units on a scale | Standard Deviation 11.412047 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | week 16 | 13.4000000 units on a scale | Standard Deviation 12.9446374 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Week 50 | 12.0606061 units on a scale | Standard Deviation 15.3030622 |
| Cognitive Behavior Therapy (CBT) | Depressive Symptoms (as Measured by the BDI-II) | Baseline | 22.1639344 units on a scale | Standard Deviation 13.1923972 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 50 | 13.6666667 units on a scale | Standard Deviation 13.6541855 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Baseline | 22.8620690 units on a scale | Standard Deviation 13.6117187 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 4 | 21.4035088 units on a scale | Standard Deviation 14.9938793 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 8 | 19.3076923 units on a scale | Standard Deviation 14.3178737 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 12 | 19.6041667 units on a scale | Standard Deviation 14.85639 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | week 16 | 17.5416667 units on a scale | Standard Deviation 15.3220163 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 20 | 15.9302326 units on a scale | Standard Deviation 14.2300744 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 24 | 15.6041667 units on a scale | Standard Deviation 14.2541365 |
| Supportive Psychotherapy (SPT) | Depressive Symptoms (as Measured by the BDI-II) | Week 37 | 12.8611111 units on a scale | Standard Deviation 13.9328036 |
Comparison: We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (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 improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\].p-value: 0.05Mixed Models Analysis
Comparison: We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (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 depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\].p-value: 0.26Mixed Models Analysis
Secondary
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])
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).
Time frame: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 4 | 14.7500000 units on a scale | Standard Deviation 5.2538501 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 20 | 9.8461538 units on a scale | Standard Deviation 6.5435322 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 12 | 10.8837209 units on a scale | Standard Deviation 5.8562515 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 24 | 8.3636364 units on a scale | Standard Deviation 7.5823875 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 8 | 14.5128205 units on a scale | Standard Deviation 5.9066056 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 37 | 6.6279070 units on a scale | Standard Deviation 7.0000791 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | week 16 | 10.8571429 units on a scale | Standard Deviation 7.2769983 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 50 | 7.1578947 units on a scale | Standard Deviation 7.96793 |
| Cognitive Behavior Therapy (CBT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Baseline | 17.2459016 units on a scale | Standard Deviation 4.2608909 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 50 | 7.3783784 units on a scale | Standard Deviation 5.7848046 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Baseline | 15.4067797 units on a scale | Standard Deviation 4.1817281 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 4 | 13.3090909 units on a scale | Standard Deviation 5.0584463 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 8 | 12.8500000 units on a scale | Standard Deviation 5.0765928 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 12 | 11.1304348 units on a scale | Standard Deviation 6.0428422 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | week 16 | 9.7608696 units on a scale | Standard Deviation 5.3465868 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 20 | 10.0277778 units on a scale | Standard Deviation 5.8235292 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 24 | 7.9791667 units on a scale | Standard Deviation 5.8908136 |
| Supportive Psychotherapy (SPT) | Insight Regarding BDD Beliefs (as Measured by the BABS) | Week 37 | 8.3170732 units on a scale | Standard Deviation 5.8199614 |
Comparison: We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (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 improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\].p-value: 0.1Mixed Models Analysis
Comparison: We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (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 improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\].p-value: 0.45Mixed Models Analysis
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).
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Week 12 | 61.0119048 units on a scale | Standard Deviation 17.3217504 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | week 24 | 68.2055749 units on a scale | Standard Deviation 19.3905036 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Week 4 | 49.6648352 units on a scale | Standard Deviation 15.8763522 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Week 37 | 69.1849817 units on a scale | Standard Deviation 17.5141781 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Week 16 | 60.8894231 units on a scale | Standard Deviation 15.9117634 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Week 50 | 66.5095899 units on a scale | Standard Deviation 21.2768017 |
| Cognitive Behavior Therapy (CBT) | Life Satisfaction (Q-LESQ-SF) | Baseline | 48.7500000 units on a scale | Standard Deviation 15.0603393 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Week 50 | 65.8928571 units on a scale | Standard Deviation 19.3884669 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Baseline | 50.6961259 units on a scale | Standard Deviation 16.6428814 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Week 4 | 51.7857143 units on a scale | Standard Deviation 18.0729259 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Week 12 | 57.6190476 units on a scale | Standard Deviation 17.638269 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Week 16 | 57.3457792 units on a scale | Standard Deviation 19.9192124 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | week 24 | 63.9437690 units on a scale | Standard Deviation 19.0175684 |
| Supportive Psychotherapy (SPT) | Life Satisfaction (Q-LESQ-SF) | Week 37 | 64.3339768 units on a scale | Standard Deviation 17.0683239 |
Comparison: We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (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 Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\].p-value: 0.04Mixed Models Analysis
Comparison: We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (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 the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\].p-value: 0.82Mixed Models Analysis
Secondary
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])
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).
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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Week 37 | 6.4871795 score on a scale | Standard Deviation 6.3613628 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Baseline | 16.3333333 score on a scale | Standard Deviation 5.5621806 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Week 4 | 15.1000000 score on a scale | Standard Deviation 6.3927574 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Week 12 | 11.7142857 score on a scale | Standard Deviation 7.4023257 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Week 16 | 9.7250000 score on a scale | Standard Deviation 7.6660674 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | week 24 | 7.9024390 score on a scale | Standard Deviation 8.2970021 |
| Cognitive Behavior Therapy (CBT) | Sheehan Disability Scale (SDS) | Week 50 | 6.6388889 score on a scale | Standard Deviation 8.1980931 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Week 37 | 9.2162162 score on a scale | Standard Deviation 7.7428646 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Week 16 | 11.7272727 score on a scale | Standard Deviation 8.2019953 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Baseline | 17.4406780 score on a scale | Standard Deviation 6.0522757 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Week 50 | 8.3666667 score on a scale | Standard Deviation 7.8013409 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Week 4 | 15.5000000 score on a scale | Standard Deviation 7.0056 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | week 24 | 9.0869565 score on a scale | Standard Deviation 7.2105666 |
| Supportive Psychotherapy (SPT) | Sheehan Disability Scale (SDS) | Week 12 | 12.2222222 score on a scale | Standard Deviation 7.8534558 |
Comparison: We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (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 improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\].p-value: 0.3Mixed Models Analysis
Comparison: We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (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 improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\].p-value: 0.85Mixed Models Analysis
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.
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Treatment Credibility (Credibility/Expectancy Rating Scale) | Week 0 | 7.10 score on a scale | Standard Deviation 1.79 |
| Cognitive Behavior Therapy (CBT) | Treatment Credibility (Credibility/Expectancy Rating Scale) | Week 4 | 7.19 score on a scale | Standard Deviation 1.68 |
| Supportive Psychotherapy (SPT) | Treatment Credibility (Credibility/Expectancy Rating Scale) | Week 0 | 6.64 score on a scale | Standard Deviation 1.84 |
| Supportive Psychotherapy (SPT) | Treatment Credibility (Credibility/Expectancy Rating Scale) | Week 4 | 6.28 score on a scale | Standard Deviation 1.84 |
Comparison: Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.p-value: 0.0095ANOVA
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.
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Treatment Expectancy (Credibility/Expectancy Rating Scale) | Week 0 | 58.36 Percent improvement expected (0-100%) | Standard Deviation 20.71 |
| Cognitive Behavior Therapy (CBT) | Treatment Expectancy (Credibility/Expectancy Rating Scale) | Week 4 | 56.00 Percent improvement expected (0-100%) | Standard Deviation 20.4 |
| Supportive Psychotherapy (SPT) | Treatment Expectancy (Credibility/Expectancy Rating Scale) | Week 0 | 50.19 Percent improvement expected (0-100%) | Standard Deviation 19.28 |
| Supportive Psychotherapy (SPT) | Treatment Expectancy (Credibility/Expectancy Rating Scale) | Week 4 | 46.73 Percent improvement expected (0-100%) | Standard Deviation 20.55 |
Comparison: Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.p-value: 0.0069ANOVA
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.
Time frame: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy (CBT) | Treatment Satisfaction (CSQ-8) | Week 12 | 28.02 score on a scale | Standard Deviation 2.88 |
| Cognitive Behavior Therapy (CBT) | Treatment Satisfaction (CSQ-8) | Week 24 | 29.40 score on a scale | Standard Deviation 3.56 |
| Supportive Psychotherapy (SPT) | Treatment Satisfaction (CSQ-8) | Week 12 | 26.60 score on a scale | Standard Deviation 3.82 |
| Supportive Psychotherapy (SPT) | Treatment Satisfaction (CSQ-8) | Week 24 | 27.56 score on a scale | Standard Deviation 4.07 |
Comparison: Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.p-value: 0.0235ANOVA