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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment

Conditions
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Body Dysmorphic Disorders

Intervention / Treatment
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* Behavioral: I-CBT for Body Dysmorphic Disorder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-CBT for Body Dysmorphic Disorder<br>All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder. | Behavioral: I-CBT for Body Dysmorphic Disorder<br>* 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.<br>* Other names: BDD-NET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G | assessment of BDD diagnostic status | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0) | assessment of current major depressive episode and other comorbid anxiety diagnoses | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Dysmorphic Concerns Questionnaire (DCQ) | used for BDD screening/ measuring dysmorphic concerns. Scores range from 0 to 28 with higher scores indicating higher severity | screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Appearance Anxiety Inventory (AAI) | A measure of BDD symptoms. The maximum total score is 40, with higher scores indicating greater frequency of a process | screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up | 
| 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. | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| 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. | screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up | 
| Skin-Picking Scale - Revised (SPS-R) | Measures skin picking severity. Scores range from 0 to 32 with higher scores indicating higher severity | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Global Assessment of Functioning (GAF) | A measure of global functioning. Scores range from 0-100 with higher scores indicating better functioning. | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Clinical Global Impressions Scale - Severity (CGI-S) | measures global severity. Scores range from 1-7 with higher scores indicating more severity. | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| Clinical Global Impressions Scale - Improvement (CGI-I) | measures global improvement. Scores range from 1-7 with low scores indicating more improvement. | post (week 12), 3 month follow-up, 12 month follow-up | 
| EuroQol - 5 Dimension Questionnaire (EQ-5D) | Measures quality of life and functioning. Scores range between 0 (dead) and 1 (perfect health). | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| 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). | baseline, post (week 12), 3 month follow-up, 12 month follow-up | 
| 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 | weeks 2, 7, and 12 (post) | 
| 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. | weeks 2, 4, 6, 8, 10, and 12 (post) | 
| 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. | baseline, weeks 2, 4, 6, 8, 10, and 12 (post) | 
| 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. | weeks 2-11, and week 12 (post) | 
| Completion of Core Treatment Modules | Have participants completed modules 1-5? | Post treatment (Week 12) | 
| Early Termination Checklist | indicates possible reasons for participants early termination from treatment. | Post treatment (Week 12) |