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

Karolinska Institutet32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Body Dysmorphic Disorders

Interventions

I-CBT for Body Dysmorphic DisorderBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, Sweden

Outcomes

Primary Outcomes

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.

Time frame: baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up

Secondary Outcomes

Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G

assessment of BDD diagnostic status

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up

Data from ClinicalTrials.gov

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