Clinical trial NCT03517384: Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment
Official title: Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Hofstra University
First posted: 2018-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
timeFrame: baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Dysmorphic Concerns Questionnaire (DCQ)
timeFrame: screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Appearance Anxiety Inventory (AAI)
timeFrame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
measure: Brown Assessment of Beliefs Scale (BABS)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)
timeFrame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
measure: Skin-Picking Scale - Revised (SPS-R)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Global Assessment of Functioning (GAF)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Clinical Global Impressions Scale - Severity (CGI-S)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Clinical Global Impressions Scale - Improvement (CGI-I)
timeFrame: post (week 12), 3 month follow-up, 12 month follow-up
measure: EuroQol - 5 Dimension Questionnaire (EQ-5D)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Sheehan Disability Scale (SDS)
timeFrame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
measure: Client Satisfaction Inventory (CSI)
timeFrame: weeks 2, 7, and 12 (post)
measure: Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: weeks 2, 4, 6, 8, 10, and 12 (post)
measure: Credibility Scale (Credibility/Expectancy Questionnaire)
timeFrame: baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
measure: Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS))
timeFrame: weeks 2-11, and week 12 (post)
measure: Completion of Core Treatment Modules
timeFrame: Post treatment (Week 12)
measure: Early Termination Checklist
timeFrame: Post treatment (Week 12)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Christian Rück, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.