Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03517384
Other study ID # BDD-GLOBAL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2016
Est. completion date June 15, 2018

Study information

Verified date September 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 15, 2018
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm Huddinge

Sponsors (3)

Lead Sponsor Collaborator
Karolinska Institutet Hofstra University, Massachusetts General Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alström K, Andersson G, Ljótsson B, Rück 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. — View Citation

Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljótsson B, Rück 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. — View Citation

Gentile AJ, La Lima C, Flygare O, Enander J, Wilhelm S, Mataix-Cols D, Rück C. Internet-based, therapist-guided, cognitive-behavioural therapy for body dysmorphic disorder with global eligibility for inclusion: an uncontrolled pilot study. BMJ Open. 2019 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up
Secondary Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G assessment of BDD diagnostic status baseline, post (week 12), 3 month follow-up, 12 month follow-up
Secondary Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0) assessment of current major depressive episode and other comorbid anxiety diagnoses baseline, post (week 12), 3 month follow-up, 12 month follow-up
Secondary Dysmorphic Concerns Questionnaire (DCQ) 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
Secondary Appearance Anxiety Inventory (AAI) 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
Secondary 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. baseline, post (week 12), 3 month follow-up, 12 month follow-up
Secondary 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. screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
Secondary Skin-Picking Scale - Revised (SPS-R) 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
Secondary Global Assessment of Functioning (GAF) 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
Secondary Clinical Global Impressions Scale - Severity (CGI-S) 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
Secondary Clinical Global Impressions Scale - Improvement (CGI-I) 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
Secondary EuroQol - 5 Dimension Questionnaire (EQ-5D) 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
Secondary 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). baseline, post (week 12), 3 month follow-up, 12 month follow-up
Secondary 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 weeks 2, 7, and 12 (post)
Secondary 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. weeks 2, 4, 6, 8, 10, and 12 (post)
Secondary 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. baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
Secondary 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. weeks 2-11, and week 12 (post)
Secondary Completion of Core Treatment Modules Have participants completed modules 1-5? Post treatment (Week 12)
Secondary Early Termination Checklist indicates possible reasons for participants early termination from treatment. Post treatment (Week 12)
See also
  Status Clinical Trial Phase
Completed NCT02524301 - Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study N/A
Completed NCT05078320 - Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder N/A
Recruiting NCT03918577 - Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders N/A
Completed NCT01398904 - Attentional Bias in Body Dysmorphic Disorder N/A
Completed NCT03773549 - A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder
Recruiting NCT05607121 - TMS Visual Modulation in Body Dysmorphic Disorder N/A
Completed NCT03221738 - Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder N/A
Completed NCT04254575 - Understanding Daily Changes in BDD Risk Using Smartphones
Completed NCT04103606 - A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students N/A
Recruiting NCT01093950 - White Light Scanning to Aid Body Contouring: A Pilot Project N/A
Recruiting NCT04899687 - Study of Dextromethorphan in OCD and Related Disorders Phase 2
Completed NCT05612425 - Text Message Safety Behavior Fading for Appearance Concerns N/A
Completed NCT06370559 - Relationship Between Repetitive Negative Thinking and CBT Outcomes
Completed NCT04656301 - Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder Phase 2
Recruiting NCT06262412 - Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder N/A
Active, not recruiting NCT04034693 - Waitlist-Control Trial of Smartphone CBT for Body Dysmorphic Disorder (BDD) N/A
Recruiting NCT06346301 - Imagery Rescripting as a Stand-alone Treatment for OCD and BDD. N/A
Recruiting NCT01316627 - Study of Patients With Body Image Issues Treated With 2 Different Behavioral Interventions Phase 2