Clinical trial NCT02635152: Interpretation Bias Modification for Body Dysmorphic Disorder
Official title: Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
measure: Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
measure: Depressive Symptom Index-Suicidality Subscale
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
measure: Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University Psychology Department
state: Florida
Study officials:
affiliation: Florida State University
name: Natalie L. Matheny, BA
role: PRINCIPAL_INVESTIGATOR
References:
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.