M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
Stockholm, Huddinge, 141 86, Sweden
NCT Number: NCT03517384
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, Huddinge, 141 86, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
assessment of BDD diagnostic status
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
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
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
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.
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.
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
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.
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.
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.
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).
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).
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
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.
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.
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.
Time frame: Post treatment (Week 12)
Have participants completed modules 1-5?
Time frame: Post treatment (Week 12)
indicates possible reasons for participants early termination from treatment.
Karolinska Institutet
Other
Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
Acronym: BDD-G
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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