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Body Dysmorphic DisordersBDD-GNCT03517384

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

A study testing I-CBT for Body Dysmorphic Disorder in people with Body Dysmorphic Disorders, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Body Dysmorphic Disorders
What is being tested?
I-CBT for Body Dysmorphic Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSweden
Study dates
20 Apr 2016to 15 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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).

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

    Stockholm, Huddinge, 141 86

Other trials in Sweden

About this study

Official title: Feasibility Pilot Study of Internet-based 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.

Being tested
I-CBT for Body Dysmorphic Disorder
Medical subject headings
Body Dysmorphic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-CBT for Body Dysmorphic DisorderBehavioural

    Also called BDD-NET

    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.

Study groups in NCT03517384
Study groupRoleWhat they receive
I-CBT for Body Dysmorphic DisorderExperimentalAll participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
Receives: Behavioral: I-CBT for Body Dysmorphic Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (18)

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

    assessment of BDD diagnostic status

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  17. Completion of Core Treatment Modules

    Have participants completed modules 1-5?

    Measured: Post treatment (Week 12)

  18. Early Termination Checklist

    indicates possible reasons for participants early termination from treatment.

    Measured: Post treatment (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start20 Apr 2016
  3. Primary completion1 Nov 2017
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03517384
Sponsor's protocol ID
BDD-GLOBAL
Acronym
BDD-G
Status last verified
Sep 2020
First submitted
10 Apr 2018
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing I-CBT for Body Dysmorphic Disorder in people with Body Dysmorphic Disorders, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03517384, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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