NCT02635152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

December 16, 2015

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

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

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

Secondary Outcomes (4)

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

    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

  • Depressive Symptom Index-Suicidality Subscale

    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

Study Arms (2)

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.

Behavioral: Interpretation Bias Modification

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.

Behavioral: Progressive Muscle Relaxation

Interventions

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

Interpretation Bias Modification (IBM)

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

Progressive Muscle Relaxation (PMR)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University Psychology Department

Tallahassee, Florida, 32304, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Natalie L. Matheny, BA

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations