NCT03517384已完成不适用
Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
时间窗: 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.
次要结局
- Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G(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)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Dysmorphic Concerns Questionnaire (DCQ)(screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Appearance Anxiety Inventory (AAI)(screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up)
- Brown Assessment of Beliefs Scale (BABS)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)(screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up)
- Skin-Picking Scale - Revised (SPS-R)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Global Assessment of Functioning (GAF)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Clinical Global Impressions Scale - Severity (CGI-S)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Clinical Global Impressions Scale - Improvement (CGI-I)(post (week 12), 3 month follow-up, 12 month follow-up)
- EuroQol - 5 Dimension Questionnaire (EQ-5D)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Sheehan Disability Scale (SDS)(baseline, post (week 12), 3 month follow-up, 12 month follow-up)
- Client Satisfaction Inventory (CSI)(weeks 2, 7, and 12 (post))
- Working Alliance Inventory - Short Revised (WAI-SR)(weeks 2, 4, 6, 8, 10, and 12 (post))
- Credibility Scale (Credibility/Expectancy Questionnaire)(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))(weeks 2-11, and week 12 (post))
- Completion of Core Treatment Modules(Post treatment (Week 12))
- Early Termination Checklist(Post treatment (Week 12))
研究者
Christian Rück
Associate Professor
Karolinska Institutet
研究点 (2)
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