Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
研究概览
简要总结
This study will be the first randomized controlled trial of Comprehensive Behavior Modification (ComB) as a treatment of trichotillomania (TTM). ComB treatment (12 weekly sessions, following a manual developed in an earlier treatment development project) will be compared to Minimal Attention Control among adults (N = 42) with TTM.
详细描述
Treatment based on the ComB model has been influential in the field of body-focused repetitive behaviors (BFRB's), but there is limited empirical research on its efficacy. Our first project (Falkenstein et al., 2016) developed a 12-session manual for ComB and a method for evaluating therapist adherence to the model that can be used reliably and provided encouraging (uncontrolled) data on the effects of ComB through 3-month follow-up.
The proposed project extends the earlier work in two main ways: (a) using random assignment to ComB vs. comparison condition to test whether ComB works better than the passage of time + demand characteristics of being in a TTM study alone; and (b) gathering initial evidence on how ComB works.
Treatment will be conducted at two sites -- Washington, DC (American University and the Behavior Therapy Center of Greater Washington) and Chicago (University of Chicago). Participants in the Minimal Attention Control condition will receive ComB therapy after the post-treatment [week 12] assessment is conducted. Uncontrolled follow-up data will be collected through 3 (MAC condition) or 6 (immediate ComB condition) months after the end of ComB treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The project coordinator at each site will conduct baseline assessments. All later assessments will be conducted by different research assistants, masked to experimental condition of the participant.
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
- •18 years of age or older
- •diagnosed with Trichotillomania
- •medication type and dosage [if any] stable for at least 3 months
排除标准
- •active suicidality
- •-probable bipolar disorder
- •probable psychosis
- •other pressing clinical problem requiring immediate treatment
- •current psychotherapy and unable/unwilling to discontinue
研究组 & 干预措施
immediate ComB
12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
干预措施: Comprehensive Behavior Modification (Behavioral)
Minimal Attention Control
Weekly brief phone call from therapist to check on participant safety, medication changes if any, and recent stressors. After week 12, participants in this arm received delayed ComB [as in the Experimental condition -- 12 weekly sessions of individual therapy for TTM based on ComB model].
干预措施: Attention (Behavioral)
结局指标
主要结局
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
时间窗: baseline (week 0), week 6, week 12, week 25, week 38
structured diagnostic interview to determine presence/absence of TTM
Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
时间窗: baseline (week 0), week 6, week 12, week 25, week 38
interviewer ratings \[to be completed by independent evaluator masked to experimental condition\] of TTM symptoms and impairment. Scores on the TSS (symptom severity) range 0 to 25, higher scores reflecting more severe symptoms. Scores on the TIS (impairment) range 0 to 10, higher scores reflecting greater impairment associated with hairpulling
Change in Massachusetts General Hospital Hairpulling Scale
时间窗: baseline (week 0), week 6, week 12, week 25, week 38
7-item self-report measure of TTM symptom severity. Score range = 0 to 28. Higher scores = more severe hairpulling symptoms in past week.
次要结局
- Alopecia rating(baseline (week 0), week 6, week 12, week 25, week 38)
- Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.](baseline (week 0), week 6, week 12, week 25, week 38)
- Stop Signal task(baseline (week 0), week 6, week 12)
- Client Satisfaction Questionnaire(week 6, week 12, week 25, week 38)
研究者
David A. F. Haaga
Professor of Psychology
American University