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Clinical Trials/NCT02635152
NCT02635152CompletedNot Applicable

Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder

Florida State University1 site in 1 country50 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)

Study Overview

Brief Summary

The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder.

Detailed Description

The present study aims to examine the feasibility of a remote treatment for body dysmorphic disorder delivered via the Internet. To evaluate the efficacy of the IBM protocol we have developed in reducing negative appearance and evaluative related interpretations, we will conduct a two-arm randomized controlled trial over the internet. Individuals with a diagnosis of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 10-25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal ideation than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on BDD symptoms will be mediated by changes in BDD-related interpretation bias; and 5) The effects of training in the IBM condition will be maintained at the 3-month follow-up assessments.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Current diagnosis of Body Dysmorphic Disorder according to DSM-5 criteria
  • •BDD-YBOCS score greater than or equal to 20
  • •Fluent in English
  • •No significant physical defect or flaw in appearance (e.g., disfiguration)

Exclusion Criteria

  • •History of psychotic disorder, bipolar disorder, borderline personality disorder
  • •Current substance use disorder
  • •Unstable medication status (i.e. change in medication within the last month)
  • •Concurrent psychotherapy for appearance concerns
  • •Active and clinically significant suicidality

Arms & Interventions

Interpretation Bias Modification (IBM)

Experimental

Treatment consists of eight brief sessions. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive positive or negative feedback based on their response.

Intervention: Interpretation Bias Modification (Behavioral)

Progressive Muscle Relaxation (PMR)

Active Comparator

Participants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove & Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups.

Intervention: Progressive Muscle Relaxation (Behavioral)

Outcomes

Primary Outcomes

Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)

Time Frame: change from baseline at one-week post treatment and 3-months post-treatment

Measures past-week BDD symptom severity

Secondary Outcomes

  • Depressive Symptom Index-Suicidality Subscale(change from baseline at one-week post treatment and 3-months post-treatment)
  • Beck Anxiety Inventory (BAI; Steer & Beck, 1997)(change from baseline at one-week post treatment and 3-months post-treatment)
  • Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)(change from baseline at one-week post treatment and 3-months post-treatment)
  • Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)(change from baseline at one-week post treatment and 3-months post-treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jesse Cougle

Associate Professor

Florida State University

Study Sites (1)

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