Trial Outcomes & Findings for CBT as an Adjunct to SRIs in the Treatment of BDD (NCT NCT00211809)

Results Overview

Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

baseline and up to 16 weeks

Results posted on

2017-03-09

Participant Flow

Subjects were recruited by advertising and other media and by referral from outside clinicians.

Participant milestones

Participant milestones
Measure	Body Dysmorphic Disorder Participants with body dysmorphic disorder Standard Psychiatric Evaluation Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
Overall Study STARTED	17
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Body Dysmorphic Disorder Participants with body dysmorphic disorder Standard Psychiatric Evaluation Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	2
Overall Study Pregnancy	1
Overall Study side effects	2

Baseline Characteristics

CBT as an Adjunct to SRIs in the Treatment of BDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Body Dysmorphic Disorder n=17 Participants Participants with body dysmorphic disorder
Age, Continuous	29.7 years STANDARD_DEVIATION 8.4 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
SSRI history SSRI naive	7 Participants n=99 Participants
SSRI history prior failed SSRI trials	10 Participants n=99 Participants

PRIMARY outcome

Timeframe: baseline and up to 16 weeks

Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint n=11 Participants Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Body Dysmorphic Disorder Examination	113.91 units on a scale Standard Deviation 27.41	107.73 units on a scale Standard Deviation 39.93

PRIMARY outcome

Timeframe: baseline and up to 16 weeks

Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint n=11 Participants Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Yale Brown Obsessive Scale Psychiatrist's Ratings for Obsessions	14.73 units on a scale Standard Deviation 2.20	11.45 units on a scale Standard Deviation 5.03
Yale Brown Obsessive Scale Psychiatrist's Ratings for Total	34.64 units on a scale Standard Deviation 5.09	26.55 units on a scale Standard Deviation 11.28
Yale Brown Obsessive Scale Psychiatrist's Ratings for Compulsions	14.82 units on a scale Standard Deviation 1.20	11.55 units on a scale Standard Deviation 4.93
Yale Brown Obsessive Scale Psychologist's Ratings for Total	35.91 units on a scale Standard Deviation 4.21	28.27 units on a scale Standard Deviation 9.49
Yale Brown Obsessive Scale Psychologist's Ratings for Obsessions	14.45 units on a scale Standard Deviation 4.57	12.09 units on a scale Standard Deviation 4.72
Yale Brown Obsessive Scale Psychologist's Ratings for Compulsions	16.09 units on a scale Standard Deviation 2.30	12.18 units on a scale Standard Deviation 3.84

PRIMARY outcome

Timeframe: baseline and up to 16 weeks

The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Body Dysmorphic Disorder Clinical Global Impressions Scale Psychiatrist's Ratings	2.73 units on a scale Standard Deviation 0.91	—
Body Dysmorphic Disorder Clinical Global Impressions Scale Psychologist's Ratings	3.00 units on a scale Standard Deviation 1.00	—

SECONDARY outcome

Timeframe: Baseline and up to 16 weeks

The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint n=11 Participants Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Brown Assessment of Beliefs Scale Psychologist's Ratings	15.91 units on a scale Standard Deviation 6.47	14.82 units on a scale Standard Deviation 6.46
Brown Assessment of Beliefs Scale Psychiatrist's Ratings	15.82 units on a scale Standard Deviation 5.19	16.91 units on a scale Standard Deviation 4.70

SECONDARY outcome

Timeframe: Baseline and up to 16 weeks

The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint n=11 Participants Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Beck Depression Inventory II	28.77 units on a scale Standard Deviation 11.49	22.18 units on a scale Standard Deviation 15.30

SECONDARY outcome

Timeframe: Baseline and up to 16 weeks

The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.

Outcome measures

Outcome measures
Measure	Baseline n=11 Participants Participants with Body Dysmorphic Disorder at baseline	Endpoint n=11 Participants Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Beck Anxiety Inventory	16.90 units on a scale Standard Deviation 8.23	12.55 units on a scale Standard Deviation 10.86

Adverse Events

Body Dysmorphic Disorder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrea Allen

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place