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Internet Delivered CBT for Body Dysmorphic Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Karolinska Institutet.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02010619
First received: November 18, 2013
Last updated: March 31, 2015
Last verified: March 2015
  Purpose
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.

Condition Intervention
Body Dysmorphic Disorder
BDD
Behavioral: Cognitive behavior therapy
Behavioral: Supportive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavior therapy Behavioral: Cognitive behavior therapy
Active Comparator: Supportive therapy Behavioral: Supportive therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010619

Locations
Sweden
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
Stockholm, Huddinge, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Rück, Associate professor, M.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02010619     History of Changes
Other Study ID Numbers: BDD RCT
Study First Received: November 18, 2013
Last Updated: March 31, 2015

Additional relevant MeSH terms:
Disease
Body Dysmorphic Disorders
Pathologic Processes
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017