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Internet Delivered CBT for Body Dysmorphic Disorder

Primary Purpose

Body Dysmorphic Disorder, BDD

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Supportive therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • outpatient
  • ≥ 18 years
  • primary diagnosis of BDD according to the DSM-5
  • BDD-YBOCS ≥20
  • regular access to a computer with Internet access and skills to use the web.

Exclusion Criteria:

  • psychotropic medication changes within two months prior to the treatment,
  • completed CBT for BDD within the last 12 months,
  • other primary axis I diagnosis
  • current substance dependence
  • lifetime bipolar disorder or psychosis
  • suicidal ideation
  • Axis II diagnosis that could jeopardize treatment participation,
  • other current psychological treatment that could affect BDD symptoms
  • A serious medical illness that precludes participation in the study

Sites / Locations

  • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavior therapy

Supportive therapy

Arm Description

Outcomes

Primary Outcome Measures

Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)

Secondary Outcome Measures

The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)

Full Information

First Posted
November 18, 2013
Last Updated
August 15, 2017
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02010619
Brief Title
Internet Delivered CBT for Body Dysmorphic Disorder
Official Title
Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

5. Study Description

Brief Summary
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder, BDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Arm Title
Supportive therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy
Primary Outcome Measure Information:
Title
Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)
Time Frame
Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
Secondary Outcome Measure Information:
Title
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Time Frame
Change in MADRS-S from baseline (week 0) to post-treatment (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: outpatient ≥ 18 years primary diagnosis of BDD according to the DSM-5 BDD-YBOCS ≥20 regular access to a computer with Internet access and skills to use the web. Exclusion Criteria: psychotropic medication changes within two months prior to the treatment, completed CBT for BDD within the last 12 months, other primary axis I diagnosis current substance dependence lifetime bipolar disorder or psychosis suicidal ideation Axis II diagnosis that could jeopardize treatment participation, other current psychological treatment that could affect BDD symptoms A serious medical illness that precludes participation in the study
Facility Information:
Facility Name
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26837684
Citation
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.
Results Reference
result
PubMed Identifier
32429939
Citation
Flygare O, Enander J, Andersson E, Ljotsson B, Ivanov VZ, Mataix-Cols D, Ruck C. Predictors of remission from body dysmorphic disorder after internet-delivered cognitive behavior therapy: a machine learning approach. BMC Psychiatry. 2020 May 19;20(1):247. doi: 10.1186/s12888-020-02655-4.
Results Reference
derived
PubMed Identifier
30647044
Citation
Enander J, Ljotsson B, Anderhell L, Runeborg M, Flygare O, Cottman O, Andersson E, Dahlen S, Lichtenstein L, Ivanov VZ, Mataix-Cols D, Ruck C. Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial. BMJ Open. 2019 Jan 15;9(1):e024307. doi: 10.1136/bmjopen-2018-024307.
Results Reference
derived

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Internet Delivered CBT for Body Dysmorphic Disorder

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