Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment
- Conditions
- Body Dysmorphic Disorders
- Registration Number
- NCT03517384
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) 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
Name Time Method Completion of Core Treatment Modules Post treatment (Week 12) Have participants completed modules 1-5?
Early Termination Checklist Post treatment (Week 12) indicates possible reasons for participants early termination from treatment.
Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G baseline, post (week 12), 3 month follow-up, 12 month follow-up assessment of BDD diagnostic status
Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0) baseline, post (week 12), 3 month follow-up, 12 month follow-up assessment of current major depressive episode and other comorbid anxiety diagnoses
Dysmorphic Concerns Questionnaire (DCQ) 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
Appearance Anxiety Inventory (AAI) 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
Brown Assessment of Beliefs Scale (BABS) 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.
Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S) 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.
Skin-Picking Scale - Revised (SPS-R) 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
Global Assessment of Functioning (GAF) 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.
Clinical Global Impressions Scale - Severity (CGI-S) 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.
Clinical Global Impressions Scale - Improvement (CGI-I) 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.
EuroQol - 5 Dimension Questionnaire (EQ-5D) 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).
Sheehan Disability Scale (SDS) 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).
Client Satisfaction Inventory (CSI) 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
Working Alliance Inventory - Short Revised (WAI-SR) 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.
Credibility Scale (Credibility/Expectancy Questionnaire) 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.
Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS)) 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.
Trial Locations
- Locations (1)
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
🇸🇪Stockholm, Huddinge, Sweden
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst🇸🇪Stockholm, Huddinge, Sweden