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CompletedNCT03517384BDD-GUpdated Sep 16, 2020

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

An interventional study of I-CBT for Body Dysmorphic Disorder in Body Dysmorphic Disorders, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Body Dysmorphic Disorders
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    I-CBT for Body Dysmorphic Disorder

    All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.

    Behavioral: I-CBT for Body Dysmorphic Disorder

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.

    Also known as: BDD-NET

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

    Time frame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up

  7. Skin-Picking Scale - Revised (SPS-R)

    Measures skin picking severity. Scores range from 0 to 32 with higher scores indicating higher severity

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

  8. Global Assessment of Functioning (GAF)

    A measure of global functioning. Scores range from 0-100 with higher scores indicating better functioning.

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

  9. Clinical Global Impressions Scale - Severity (CGI-S)

    measures global severity. Scores range from 1-7 with higher scores indicating more severity.

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

  10. Clinical Global Impressions Scale - Improvement (CGI-I)

    measures global improvement. Scores range from 1-7 with low scores indicating more improvement.

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

  11. EuroQol - 5 Dimension Questionnaire (EQ-5D)

    Measures quality of life and functioning. Scores range between 0 (dead) and 1 (perfect health).

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

  12. 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).

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

  13. 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

    Time frame: weeks 2, 7, and 12 (post)

  14. 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.

    Time frame: weeks 2, 4, 6, 8, 10, and 12 (post)

  15. 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.

    Time frame: baseline, weeks 2, 4, 6, 8, 10, and 12 (post)

  16. 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.

    Time frame: weeks 2-11, and week 12 (post)

  17. Completion of Core Treatment Modules

    Have participants completed modules 1-5?

    Time frame: Post treatment (Week 12)

  18. Early Termination Checklist

    indicates possible reasons for participants early termination from treatment.

    Time frame: Post treatment (Week 12)

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Study locations

1 site
  • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
    Stockholm, Huddinge 141 86, Sweden
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References and documents

Publications

  • 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. PubMed 26837684 ↗
  • 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. PubMed 25256187 ↗
  • 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. PubMed 30904854 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03517384
Lead sponsor
Karolinska Institutet
Collaborators
Massachusetts General Hospital, Hofstra University
Responsible party
Christian Rück (Associate Professor, Karolinska Institutet) — Principal investigator
First posted
May 7, 2018
Start date
Apr 20, 2016
Primary completion
Nov 1, 2017
Completion
Jun 15, 2018
Last update
Sep 16, 2020

Study contacts

Christian Rück, MD PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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