Interpretation Bias Modification for Body Dysmorphic Disorder

January 26, 2021 updated by: Jesse Cougle, Florida State University

Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tallahassee, Florida, United States, 32304
        • Florida State University Psychology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interpretation Bias Modification (IBM)
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.
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
Active Comparator: Progressive Muscle Relaxation (PMR)
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.
Eight 15-minute sessions of progressive muscle relaxation (PMR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline at one-week post treatment and 3-months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
Measures depressive symptom severity
change from baseline at one-week post treatment and 3-months post-treatment
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
Measure anxious symptom severity
change from baseline at one-week post treatment and 3-months post-treatment
Depressive Symptom Index-Suicidality Subscale
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
Measure severity of recent suicidality
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)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
Measure of strength of BDD-related (i.e. evaluation- and appearance- related threat interpretation biases)
change from baseline at one-week post treatment and 3-months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Natalie L. Matheny, BA, Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017.20244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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