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
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 32 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: BDD-NET
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
Completion of Core Treatment Modules
Have participants completed modules 1-5?
Time frame: Post treatment (Week 12)
Early Termination Checklist
indicates possible reasons for participants early termination from treatment.
Time frame: Post treatment (Week 12)
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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