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

September 14, 2020 updated by: Christian Rück, Karolinska Institutet

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden, 141 86
        • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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
screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up
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
screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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.
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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.
screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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.
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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.
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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.
post (week 12), 3 month follow-up, 12 month follow-up
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).
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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).
baseline, post (week 12), 3 month follow-up, 12 month follow-up
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
weeks 2, 7, and 12 (post)
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.
weeks 2, 4, 6, 8, 10, and 12 (post)
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.
baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
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.
weeks 2-11, and week 12 (post)
Completion of Core Treatment Modules
Time Frame: Post treatment (Week 12)
Have participants completed modules 1-5?
Post treatment (Week 12)
Early Termination Checklist
Time Frame: Post treatment (Week 12)
indicates possible reasons for participants early termination from treatment.
Post treatment (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
Hofstra University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Rück, MD PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BDD-GLOBAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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