Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01453439
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Duration (Months): 70.2
• Patients Per Site: 60
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Dysmorphic Disorder; Obsessive-Compulsive Spectrum Disorder; Anxiety Disorders; Somatoform Disorders	Behavioral: Cognitive Behavioral Therapy; Behavioral: Supportive Psychotherapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jan 5, 2017
• Actual Study Completion Date: Jun 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy Group receiving Cognitive-Behavioral Therapy	Behavioral: Cognitive 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.; Other Names: CBT
Active Comparator: Supportive Psychotherapy Group receiving Supportive Psychotherapy	Behavioral: Supportive 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.; Other Names: SPT

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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.

5. 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])]

6. Neuropsychological Functioning (as Measured by the ROCF) [Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])]

7. Information Processing (as Measured by the ERT) [Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])]

8. 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).

9. 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.

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Rhode Island Hospital	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Sabine Wilhelm, Ph.D., Massachusetts General Hospital
• Principal Investigator: Katharine Phillips, M.D., Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to visit the official website of the Body Dysmorphic Disorder Clinic at MGH

Publications

None provided.

• Responsible Party: Sabine Wilhelm, PhD, Sabine Wilhelm, PhD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01453439
• Other Study ID Numbers: R01MH091078; R01MH091078; 2010-P-001021/2
• First Posted: Oct 17, 2011
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Sabine Wilhelm, PhD, Sabine Wilhelm, PhD, Massachusetts General Hospital: Body dysmorphic disorder; Obsessive compulsive spectrum disorder; Body image; Appearance concerns
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Body Dysmorphic Disorders; Somatoform Disorders

Study Results

Participant Flow

Arm/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	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.	SPT is a widely received psychosocial treatment by persons with BDD.
Period Title: Treatment Phase
STARTED	61	59
COMPLETED	44	48
NOT COMPLETED	17	11
Period Title: Treatment Phase
STARTED	44	48
COMPLETED	39	37
NOT COMPLETED	5	11

Baseline Characteristics

Arm/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)	Total
Arm/Group Description	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.	SPT is a widely received psychosocial treatment by persons with BDD.	Total of all reporting groups
Overall Participants	61	59	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.5 (14.5)	33.4 (11.5)	33.9 (12.9)
Sex: Female, Male (Count of Participants)
Female	46 75.4%	46 78%	92 76.7%
Male	15 24.6%	13 22%	28 23.3%
Race/Ethnicity, Customized (Count of Participants)
White, Non-Hispanic	47 77%	53 89.8%	100 83.3%
White, Hispanic	2 3.3%	2 3.4%	4 3.3%
Black	1 1.6%	1 1.7%	2 1.7%
Asian/Pacific Islander	6 9.8%	1 1.7%	7 5.8%
Other	5 8.2%	2 3.4%	7 5.8%
Region of Enrollment (Count of Participants)
United States	61 100%	59 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	61	59
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments	Degrees of freedom=90.9
	Method	Mixed Models Analysis
	Comments	Effect of interest: time by group interaction
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.4602
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1249
	Estimation Comments	The estimated value describes the mean slope difference of CBT compared to SPT.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.62
	Comments	Degrees of freedom=74.7
	Method	Mixed Models Analysis
	Comments	The effect of interest was the time by group interaction.
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.00984
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1038
	Estimation Comments	The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).

2. Secondary Outcome

Title	Insight Regarding BDD Beliefs (as Measured by the BABS)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	61	59
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.10
	Comments	Degrees of freedom=93.2
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.45
	Comments	Degrees of freedom=74.5
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Depressive Symptoms (as Measured by the BDI-II)
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	61	59
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments	Degrees of freedom=89.1
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.26
	Comments	Degrees of freedom=63.7
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Life Satisfaction (Q-LESQ-SF)
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	61	59
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments	Degrees of freedom=91.4
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.82
	Comments	Degrees of freedom=74.7
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Treatment Credibility (Credibility/Expectancy Rating Scale)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	55	54
Week 0	7.10 (1.79)	6.64 (1.84)
Week 4	7.19 (1.68)	6.28 (1.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0095
	Comments	Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions
	Method	ANOVA
	Comments	repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.7937
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3007
	Estimation Comments	Least Squares Means difference

6. Secondary Outcome

Title	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])

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	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])

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	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])

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Sheehan Disability Scale (SDS)
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	61	59
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.30
	Comments	Degrees of freedom=88.0
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	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].
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.85
	Comments	Degrees of freedom=74.5
	Method	Mixed Models Analysis
	Comments

10. Secondary Outcome

Title	Treatment Satisfaction (CSQ-8)
Description	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]

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	47	52
Week 12	28.02 (2.88)	26.60 (3.82)
Week 24	29.40 (3.56)	27.56 (4.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0235
	Comments	a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions
	Method	ANOVA
	Comments	repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.5867
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6882
	Estimation Comments	Least Squares Means difference

11. Secondary Outcome

Title	Treatment Expectancy (Credibility/Expectancy Rating Scale)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Cognitive Behavior Therapy (CBT)	Supportive Psychotherapy (SPT)
Arm/Group Description	Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.	SPT is the most common psychosocial treatment received by persons with BDD.
Measure Participants	55	54
Week 0	58.36 (20.71)	50.19 (19.28)
Week 4	56.00 (20.40)	46.73 (20.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavior Therapy (CBT), Supportive Psychotherapy (SPT)
	Comments	Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0069
	Comments	a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions
	Method	ANOVA
	Comments	repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	9.4390
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.4259
	Estimation Comments	Least Squares Mean difference

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	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.
Arm/Group Title	Cognitive Behavior Therapy (CBT)		Supportive Psychotherapy (SPT)
Arm/Group Description	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.		SPT is a widely received psychosocial treatment by persons with BDD.
All Cause Mortality
	Cognitive Behavior Therapy (CBT)		Supportive Psychotherapy (SPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/59 (0%)
Serious Adverse Events
	Cognitive Behavior Therapy (CBT)		Supportive Psychotherapy (SPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/61 (8.2%)		3/59 (5.1%)
Cardiac disorders
Cardiac surgery	1/61 (1.6%)	1	0/59 (0%)	0
Gastrointestinal disorders
Negative reaction to anesthesia	1/61 (1.6%)	1	0/59 (0%)	0
General disorders
Pain felt in one arm for a couple of days	1/61 (1.6%)	1	0/59 (0%)	0
Immune system disorders
Anaphylactic shock	0/61 (0%)	0	1/59 (1.7%)	1
Infections and infestations
Mononucleosis	0/61 (0%)	0	1/59 (1.7%)	1
Psychiatric disorders
Suicidal ideation	1/61 (1.6%)	1	1/59 (1.7%)	1
Increase in BDD and depressive Symptoms	1/61 (1.6%)	2	0/59 (0%)	0
Self-harm	1/61 (1.6%)	1	0/59 (0%)	0
Other (Not Including Serious) Adverse Events
	Cognitive Behavior Therapy (CBT)		Supportive Psychotherapy (SPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/61 (55.7%)		30/59 (50.8%)
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications	9/61 (14.8%)	16	5/59 (8.5%)	6
Nervous system disorders
Nervous system disorders	4/61 (6.6%)	4	3/59 (5.1%)	3
Psychiatric disorders
Increased anxiety and/or depression	8/61 (13.1%)	12	13/59 (22%)	14
Increase in other psychiatric symptoms	8/61 (13.1%)	8	3/59 (5.1%)	3
Suicidal ideation and/or self-harm	4/61 (6.6%)	6	1/59 (1.7%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	2/61 (3.3%)	2	3/59 (5.1%)	3
Social circumstances
Social circumstances	2/61 (3.3%)	2	3/59 (5.1%)	3
Surgical and medical procedures
Surgical and medical procedures	2/61 (3.3%)	2	4/59 (6.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.