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Completed

NCT Number: NCT03517384

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I-CBT for Body Dysmorphic Disorder

Behavioral

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 names: BDD-NET

Primary outcomes

  1. Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

    Time frame: 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 outcomes

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

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

    assessment of BDD diagnostic status

  2. Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)

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

    assessment of current major depressive episode and other comorbid anxiety diagnoses

  3. Dysmorphic Concerns Questionnaire (DCQ)

    Time frame: 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

  4. Appearance Anxiety Inventory (AAI)

    Time frame: 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

  5. Brown Assessment of Beliefs Scale (BABS)

    Time frame: 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.

  6. Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)

    Time frame: 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.

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

    Time frame: 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

  8. Global Assessment of Functioning (GAF)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

  12. Sheehan Disability Scale (SDS)

    Time frame: 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).

  13. Client Satisfaction Inventory (CSI)

    Time frame: 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

  14. Working Alliance Inventory - Short Revised (WAI-SR)

    Time frame: 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.

  15. Credibility Scale (Credibility/Expectancy Questionnaire)

    Time frame: 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.

  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))

    Time frame: 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.

  17. Completion of Core Treatment Modules

    Time frame: Post treatment (Week 12)

    Have participants completed modules 1-5?

  18. Early Termination Checklist

    Time frame: Post treatment (Week 12)

    indicates possible reasons for participants early termination from treatment.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Hofstra University
  • Massachusetts General Hospital

Registry information

Official study title

Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment

Acronym: BDD-G

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 7, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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