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

NCT ID: NCT03517384

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-20

Study Completion Date

2018-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Body Dysmorphic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-CBT for Body Dysmorphic Disorder

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

Group Type EXPERIMENTAL

I-CBT for Body Dysmorphic Disorder

Intervention Type 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.

Interventions

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I-CBT for Body Dysmorphic Disorder

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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BDD-NET

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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).
* Additionally, eligibility continues to be assessed on an ongoing basis after initial inclusion. The MADRS-S, Appearance Anxiety Questionnaire (AAI), and Adverse Events Questionnaire (AEQ) are administered weekly in order to ensure that the treatment study continues to be a safe and appropriate level of care for participants.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Hofstra University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Christian Rück

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Rück, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 26837684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25256187 (View on PubMed)

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.

Reference Type RESULT
PMID: 30904854 (View on PubMed)

Other Identifiers

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BDD-GLOBAL

Identifier Type: -

Identifier Source: org_study_id

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