Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment

NCT03517384 | Completed

• 1 other identifier: BDD-GLOBAL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to study an english-language version of BDD-NET (Enander, et al., 2014; Enander, et al., 2016), an internet-based treatment for Body Dysmorphic Disorder, on a globally recruited sample. This is an uncontrolled pilot study where a within-subjects repeated measures design was used to assess the feasibility of conducting all aspects of the study remotely, including recruitment, assessment, and treatment delivery.

Conditions

Body Dysmorphic Disorders

Outcome Measures

Primary Outcomes (1)

• Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

  A measure of BDD symptom severity. Scores range from 0-48 with higher scores indicating greater severity.

  baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up

Secondary Outcomes (18)

• Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G

  baseline, post (week 12), 3 month follow-up, 12 month follow-up

• Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)

  baseline, post (week 12), 3 month follow-up, 12 month follow-up

• Dysmorphic Concerns Questionnaire (DCQ)

  screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up

• Appearance Anxiety Inventory (AAI)

  screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up

• Brown Assessment of Beliefs Scale (BABS)

  baseline, post (week 12), 3 month follow-up, 12 month follow-up

Study Arms (1)

I-CBT for Body Dysmorphic Disorder

EXPERIMENTAL

All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.

Behavioral: I-CBT for Body Dysmorphic Disorder

Interventions

I-CBT for Body Dysmorphic Disorder BEHAVIORAL

The current intervention, is a therapist guided, Internet Cognitive Behavioral Therapy treatment for Body Dysmporhic Disorder which consists of 8 treatment modules administered over the course of 12 weeks.

Also known as: BDD-NET

I-CBT for Body Dysmorphic Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current outpatient status (not currently admitted for inpatient care)
• Patient is fluent in English
• Patient has regular access to a computer with an Internet connection
• Patient has adequate skills to use the Internet effectively.
• Patient provides informed consent (both verbal, and click yes to consent on secure web page)
• Patient is 18 years of age or older (able to provide government issued photo ID)
• Patient has primary diagnosis of DSM-5 Body Dysmorphic Disorder, (determined using the SCID-5 module "G" which assesses diagnostic criteria on obsessive compulsive spectrum disorders)
• score ≥ 4 on the Body Dysmorphic Disorder Questionnaire (BDDQ),
• score ≥ 9 on the Dysmorphic Concern Questionnaire (DCQ)
• score ≥ 20 on the Body Dysmorphic Disorder Modification of the Yale Brown Obsessive Compulsive Scale (BDD-YBOCS).

You may not qualify if:

• Patient received Cognitive Behavior Therapy for Body Dysmporphic Disorder in the 12 months preceding treatment
• Patient changed psychotropic medications within the 12 weeks before treatment
• Patient receiving other ongoing psychotherapy at the time,
• Patient did not have access to a 24 hour psychiatric emergency center
• Patient could not provide an emergency contact person.
• Current substance dependence (assessed with M.I.N.I. 7.0, AUDIT, DUDIT)
• Lifetime bipolar disorder diagnosis (assessed with M.I.N.I. 7.0 and self-report)
• Psychosis present
• Severe depression (assessed with M.I.N.I., MADRS-S score ≥ 35)
• Personality disorder diagnosis (self-report and video-conference diagnostic interview),
• Lifetime history of suicide attempts (self-report) or clinically significant current suicidal ideation (≥ 5 on item 9 of MADRS-S; Columbia Suicide Severity Rating Scale (C-SSRS Lifetime Recent) - Clinical Version: Recent (past month) - Most Severe Ideation score ≥ 4).

Sponsors & Collaborators

• Karolinska Institutet: lead
• Massachusetts General Hospital: collaborator
• Hofstra University: collaborator

Study Sites (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, 141 86, Sweden

Location

Related Publications (3)

• Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alstrom K, Andersson G, Ljotsson B, Ruck C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.

  PMID: 26837684 BACKGROUND

• Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljotsson B, Ruck C. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open. 2014 Sep 25;4(9):e005923. doi: 10.1136/bmjopen-2014-005923.

  PMID: 25256187 BACKGROUND

• Gentile AJ, La Lima C, Flygare O, Enander J, Wilhelm S, Mataix-Cols D, Ruck C. Internet-based, therapist-guided, cognitive-behavioural therapy for body dysmorphic disorder with global eligibility for inclusion: an uncontrolled pilot study. BMJ Open. 2019 Mar 23;9(3):e024693. doi: 10.1136/bmjopen-2018-024693.

  PMID: 30904854 RESULT

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Christian Rück, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 7, 2018
• Study Start: April 20, 2016
• Primary Completion: November 1, 2017
• Study Completion: June 15, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)