Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02635152
Other study ID # 2017.20244
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date March 2018

Study information

Verified date January 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interpretation Bias Modification
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
Progressive Muscle Relaxation
Eight 15-minute sessions of progressive muscle relaxation (PMR).

Locations

Country Name City State
United States Florida State University Psychology Department Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996) Measures depressive symptom severity change from baseline at one-week post treatment and 3-months post-treatment
Secondary Beck Anxiety Inventory (BAI; Steer & Beck, 1997) Measure anxious symptom severity change from baseline at one-week post treatment and 3-months post-treatment
Secondary Depressive Symptom Index-Suicidality Subscale Measure severity of recent suicidality change from baseline at one-week post treatment and 3-months post-treatment
Secondary 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) change from baseline at one-week post treatment and 3-months post-treatment
See also
  Status Clinical Trial Phase
Completed NCT03673046 - Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD) N/A
Recruiting NCT05402475 - Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder N/A
Withdrawn NCT02843451 - Milk Thistle in Body Dysmorphic Disorder Phase 2
Completed NCT02010619 - Internet Delivered CBT for Body Dysmorphic Disorder N/A
Completed NCT00842309 - D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder Early Phase 1
Completed NCT00245635 - Fluoxetine in Pediatric Body Dysmorphic Disorder Phase 4
Completed NCT02808702 - Brain Correlates of Self-Focused Processing N/A
Completed NCT01002326 - Cognitive-Behavioral Therapy for Pediatric Body Dysmorphic Disorder N/A
Active, not recruiting NCT01075672 - Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals N/A
Completed NCT02671266 - Oxytocin Administration in BDD and OCD Phase 2
Completed NCT01038128 - An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder N/A
Completed NCT01398865 - Escitalopram Neuroimaging Supplement N/A
Completed NCT00265109 - Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder Phase 4
Recruiting NCT04373629 - Perceptual Abnormalities and Their Malleability in BDD N/A
Completed NCT01453439 - Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder N/A
Completed NCT00871143 - Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD) N/A
Completed NCT00106223 - Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder N/A
Active, not recruiting NCT00211809 - CBT as an Adjunct to SRIs in the Treatment of BDD Phase 4