Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment
NCT ID: NCT03517384
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2016-04-20
2018-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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I-CBT for Body Dysmorphic Disorder
All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
I-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.
Interventions
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I-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Hofstra University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Christian Rück
Associate Professor
Principal Investigators
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Christian Rück, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
Stockholm, Huddinge, Sweden
Countries
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References
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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.
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.
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.
Other Identifiers
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BDD-GLOBAL
Identifier Type: -
Identifier Source: org_study_id
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