Body Dysmorphic Disorders
Conditions
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.
Interventions
BEHAVIORALI-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.
Sponsors
Massachusetts General Hospital
Hofstra University
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
Sweden
Outcome results
None listed