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Interpretation Bias Modification for Body Dysmorphic Disorder

Primary Purpose

Body Dysmorphic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpretation Bias Modification
Progressive Muscle Relaxation
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University Psychology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpretation Bias Modification (IBM)

Progressive Muscle Relaxation (PMR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Measures depressive symptom severity
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Measure anxious symptom severity
Depressive Symptom Index-Suicidality Subscale
Measure severity of recent suicidality
Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
Measure of strength of BDD-related (i.e. evaluation- and appearance- related threat interpretation biases)

Full Information

First Posted
December 16, 2015
Last Updated
January 26, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT02635152
Brief Title
Interpretation Bias Modification for Body Dysmorphic Disorder
Official Title
Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpretation Bias Modification (IBM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Progressive Muscle Relaxation (PMR)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Interpretation Bias Modification
Intervention Description
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
Eight 15-minute sessions of progressive muscle relaxation (PMR).
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)
Description
Measures past-week BDD symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Description
Measures depressive symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Title
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Description
Measure anxious symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Title
Depressive Symptom Index-Suicidality Subscale
Description
Measure severity of recent suicidality
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Title
Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
Description
Measure of strength of BDD-related (i.e. evaluation- and appearance- related threat interpretation biases)
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie L. Matheny, BA
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University Psychology Department
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30589349
Citation
Wilver NL, Cougle JR. An Internet-based controlled trial of interpretation bias modification versus progressive muscle relaxation for body dysmorphic disorder. J Consult Clin Psychol. 2019 Mar;87(3):257-269. doi: 10.1037/ccp0000372. Epub 2018 Dec 27.
Results Reference
derived

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Interpretation Bias Modification for Body Dysmorphic Disorder

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