Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517384
Recruitment Status : Active, not recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
Hofstra University
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorders Behavioral: I-CBT for Body Dysmorphic Disorder Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
Actual Study Start Date : April 20, 2016
Actual Primary Completion Date : November 1, 2017
Estimated Study Completion Date : July 15, 2018

Arm Intervention/treatment
Experimental: I-CBT for Body Dysmorphic Disorder
All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
Behavioral: 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.
Other Name: BDD-NET




Primary Outcome Measures :
  1. Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) [ Time Frame: baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up ]
    A measure of BDD symptom severity. Scores range from 0-48 with higher scores indicating greater severity.


Secondary Outcome Measures :
  1. Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    assessment of BDD diagnostic status

  2. Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    assessment of current major depressive episode and other comorbid anxiety diagnoses

  3. Dysmorphic Concerns Questionnaire (DCQ) [ Time Frame: screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    used for BDD screening/ measuring dysmorphic concerns. Scores range from 0 to 28 with higher scores indicating higher severity

  4. Appearance Anxiety Inventory (AAI) [ Time Frame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up ]
    A measure of BDD symptoms. The maximum total score is 40, with higher scores indicating greater frequency of a process

  5. Brown Assessment of Beliefs Scale (BABS) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    Measures conviction and insight regarding beliefs/ obsessions. Scores can range from 0 to 24 with higher scores indicating poorer insight.

  6. Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S) [ Time Frame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up ]
    measures depressive symptoms and suicidal ideation. Scores range from 0-54 with higher scores indicating higher severity.

  7. Skin-Picking Scale - Revised (SPS-R) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    Measures skin picking severity. Scores range from 0 to 32 with higher scores indicating higher severity

  8. Global Assessment of Functioning (GAF) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    A measure of global functioning. Scores range from 0-100 with higher scores indicating better functioning.

  9. Clinical Global Impressions Scale - Severity (CGI-S) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    measures global severity. Scores range from 1-7 with higher scores indicating more severity.

  10. Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: post (week 12), 3 month follow-up, 12 month follow-up ]
    measures global improvement. Scores range from 1-7 with low scores indicating more improvement.

  11. EuroQol - 5 Dimension Questionnaire (EQ-5D) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    Measures quality of life and functioning. Scores range between 0 (dead) and 1 (perfect health).

  12. Sheehan Disability Scale (SDS) [ Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up ]
    The SDS has 3 items measuring functional impairment and disability regarding work/school, social life/leisure, and family life/home responsibilities on a likert scale between 0 (no interference) to 10 (extreme impairment). Two items measure days lost at work/school and days being underproductive at work/school. Items are on a likert scale of 0 (not at all) to 10 (very severe).

  13. Client Satisfaction Inventory (CSI) [ Time Frame: weeks 2, 7, and 12 (post) ]
    Measures participants' satisfaction with treatment. Total raw scores on this measure range 0 to 175 with higher scores indicating higher satisfaction

  14. Working Alliance Inventory - Short Revised (WAI-SR) [ Time Frame: weeks 2, 4, 6, 8, 10, and 12 (post) ]
    Measures working alliance between therapist and patient. Scores range from 0-60 with higher scores indicating better working alliance.

  15. Credibility Scale (Credibility/Expectancy Questionnaire) [ Time Frame: baseline, weeks 2, 4, 6, 8, 10, and 12 (post) ]
    Measures patients' perception of the credibility of treatment and expectations for treatment outcome. Scores range from 0-55 with higher scores indicating better expectations of treatment outcome and higher perceptions that the treatment is credible.

  16. Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS)) [ Time Frame: weeks 2-11, and week 12 (post) ]
    Measures patients adherence to treatment. Raw scores range from 0-62 with higher scores indicating more adherence to treatment.

  17. Completion of Core Treatment Modules [ Time Frame: Post treatment (Week 12) ]
    Have participants completed modules 1-5?

  18. Early Termination Checklist [ Time Frame: Post treatment (Week 12) ]
    indicates possible reasons for participants early termination from treatment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517384


Locations
Layout table for location information
Sweden
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
Stockholm, Huddinge, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Massachusetts General Hospital
Hofstra University
Investigators
Layout table for investigator information
Principal Investigator: Christian Rück, MD PhD Karolinska Institutet

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christian Rück, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03517384     History of Changes
Other Study ID Numbers: BDD-GLOBAL
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders