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CompletedNCT02635152Updated Jan 29, 2021

Interpretation Bias Modification for Body Dysmorphic Disorder

An interventional study of Interpretation Bias Modification and Progressive Muscle Relaxation in Body Dysmorphic Disorder, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Body Dysmorphic Disorder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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.

    Behavioral: Interpretation Bias Modification

  • 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.

    Behavioral: Progressive Muscle Relaxation

Interventions

  • BehavioralInterpretation Bias Modification

    Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.

  • BehavioralProgressive Muscle Relaxation

    Eight 15-minute sessions of progressive muscle relaxation (PMR).

05

What researchers measure

Primary outcomes

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

    Measures past-week BDD symptom severity

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

Secondary outcomes

  1. Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)

    Measures depressive symptom severity

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

  2. Beck Anxiety Inventory (BAI; Steer & Beck, 1997)

    Measure anxious symptom severity

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

  3. Depressive Symptom Index-Suicidality Subscale

    Measure severity of recent suicidality

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

  4. 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)

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

06

Study locations

1 site
  • Florida State University Psychology Department
    Tallahassee, Florida 32304, United States
07

References and documents

Publications

  • 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. PubMed 30589349 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT02635152
Lead sponsor
Florida State University
Responsible party
Jesse Cougle (Associate Professor, Florida State University) — Principal investigator
First posted
Dec 18, 2015
Start date
Sep 2015
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Jan 29, 2021

Study contacts

Natalie L. Matheny, BA
principal investigator · Florida State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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