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

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Karolinska Institute

Status

Completed

Conditions

Body Dysmorphic Disorders

Treatments

Behavioral: I-CBT for Body Dysmorphic Disorder

Study type

Interventional

Funder types

Other

Identifiers

NCT03517384
BDD-GLOBAL

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

I-CBT for Body Dysmorphic Disorder
Experimental group
Description:
All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
Treatment:
Behavioral: I-CBT for Body Dysmorphic Disorder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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