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

Primary Purpose

Body Dysmorphic Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
I-CBT for Body Dysmorphic Disorder
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorders

Eligibility Criteria

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

Sites / Locations

  • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I-CBT for Body Dysmorphic Disorder

Arm Description

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

Outcomes

Primary Outcome Measures

Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
A measure of BDD symptom severity. Scores range from 0-48 with higher scores indicating greater severity.

Secondary Outcome Measures

Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G
assessment of BDD diagnostic status
Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)
assessment of current major depressive episode and other comorbid anxiety diagnoses
Dysmorphic Concerns Questionnaire (DCQ)
used for BDD screening/ measuring dysmorphic concerns. Scores range from 0 to 28 with higher scores indicating higher severity
Appearance Anxiety Inventory (AAI)
A measure of BDD symptoms. The maximum total score is 40, with higher scores indicating greater frequency of a process
Brown Assessment of Beliefs Scale (BABS)
Measures conviction and insight regarding beliefs/ obsessions. Scores can range from 0 to 24 with higher scores indicating poorer insight.
Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)
measures depressive symptoms and suicidal ideation. Scores range from 0-54 with higher scores indicating higher severity.
Skin-Picking Scale - Revised (SPS-R)
Measures skin picking severity. Scores range from 0 to 32 with higher scores indicating higher severity
Global Assessment of Functioning (GAF)
A measure of global functioning. Scores range from 0-100 with higher scores indicating better functioning.
Clinical Global Impressions Scale - Severity (CGI-S)
measures global severity. Scores range from 1-7 with higher scores indicating more severity.
Clinical Global Impressions Scale - Improvement (CGI-I)
measures global improvement. Scores range from 1-7 with low scores indicating more improvement.
EuroQol - 5 Dimension Questionnaire (EQ-5D)
Measures quality of life and functioning. Scores range between 0 (dead) and 1 (perfect health).
Sheehan Disability Scale (SDS)
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).
Client Satisfaction Inventory (CSI)
Measures participants' satisfaction with treatment. Total raw scores on this measure range 0 to 175 with higher scores indicating higher satisfaction
Working Alliance Inventory - Short Revised (WAI-SR)
Measures working alliance between therapist and patient. Scores range from 0-60 with higher scores indicating better working alliance.
Credibility Scale (Credibility/Expectancy Questionnaire)
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.
Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS))
Measures patients adherence to treatment. Raw scores range from 0-62 with higher scores indicating more adherence to treatment.
Completion of Core Treatment Modules
Have participants completed modules 1-5?
Early Termination Checklist
indicates possible reasons for participants early termination from treatment.

Full Information

First Posted
April 10, 2018
Last Updated
September 14, 2020
Sponsor
Karolinska Institutet
Collaborators
Massachusetts General Hospital, Hofstra University
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1. Study Identification

Unique Protocol Identification Number
NCT03517384
Brief Title
Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment
Acronym
BDD-G
Official Title
Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2016 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Massachusetts General Hospital, Hofstra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-CBT for Body Dysmorphic Disorder
Arm Type
Experimental
Arm Description
All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
Intervention Type
Behavioral
Intervention Name(s)
I-CBT for Body Dysmorphic Disorder
Other Intervention Name(s)
BDD-NET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Description
A measure of BDD symptom severity. Scores range from 0-48 with higher scores indicating greater severity.
Time Frame
baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up
Secondary Outcome Measure Information:
Title
Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G
Description
assessment of BDD diagnostic status
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)
Description
assessment of current major depressive episode and other comorbid anxiety diagnoses
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Dysmorphic Concerns Questionnaire (DCQ)
Description
used for BDD screening/ measuring dysmorphic concerns. Scores range from 0 to 28 with higher scores indicating higher severity
Time Frame
screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Appearance Anxiety Inventory (AAI)
Description
A measure of BDD symptoms. The maximum total score is 40, with higher scores indicating greater frequency of a process
Time Frame
screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
Title
Brown Assessment of Beliefs Scale (BABS)
Description
Measures conviction and insight regarding beliefs/ obsessions. Scores can range from 0 to 24 with higher scores indicating poorer insight.
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)
Description
measures depressive symptoms and suicidal ideation. Scores range from 0-54 with higher scores indicating higher severity.
Time Frame
screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
Title
Skin-Picking Scale - Revised (SPS-R)
Description
Measures skin picking severity. Scores range from 0 to 32 with higher scores indicating higher severity
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Global Assessment of Functioning (GAF)
Description
A measure of global functioning. Scores range from 0-100 with higher scores indicating better functioning.
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Clinical Global Impressions Scale - Severity (CGI-S)
Description
measures global severity. Scores range from 1-7 with higher scores indicating more severity.
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Clinical Global Impressions Scale - Improvement (CGI-I)
Description
measures global improvement. Scores range from 1-7 with low scores indicating more improvement.
Time Frame
post (week 12), 3 month follow-up, 12 month follow-up
Title
EuroQol - 5 Dimension Questionnaire (EQ-5D)
Description
Measures quality of life and functioning. Scores range between 0 (dead) and 1 (perfect health).
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Sheehan Disability Scale (SDS)
Description
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).
Time Frame
baseline, post (week 12), 3 month follow-up, 12 month follow-up
Title
Client Satisfaction Inventory (CSI)
Description
Measures participants' satisfaction with treatment. Total raw scores on this measure range 0 to 175 with higher scores indicating higher satisfaction
Time Frame
weeks 2, 7, and 12 (post)
Title
Working Alliance Inventory - Short Revised (WAI-SR)
Description
Measures working alliance between therapist and patient. Scores range from 0-60 with higher scores indicating better working alliance.
Time Frame
weeks 2, 4, 6, 8, 10, and 12 (post)
Title
Credibility Scale (Credibility/Expectancy Questionnaire)
Description
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.
Time Frame
baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
Title
Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS))
Description
Measures patients adherence to treatment. Raw scores range from 0-62 with higher scores indicating more adherence to treatment.
Time Frame
weeks 2-11, and week 12 (post)
Title
Completion of Core Treatment Modules
Description
Have participants completed modules 1-5?
Time Frame
Post treatment (Week 12)
Title
Early Termination Checklist
Description
indicates possible reasons for participants early termination from treatment.
Time Frame
Post treatment (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Rück, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
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

Plan to Share IPD
No
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
background
PubMed Identifier
25256187
Citation
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.
Results Reference
background
PubMed Identifier
30904854
Citation
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.
Results Reference
result

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

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