Cognitive Behavioral Therapy for Trichotillomania
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- NIMH Trichotillomania Impairment Scale (NIMH-TIS)
研究概览
简要总结
This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid affective symptoms, as well. The study will compare the efficacy of CBT with a minimal attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and 6-month follow-up will be better for the CBT vs. MAC condition including higher responder rates and greater reduction in hair pulling severity.
详细描述
The purpose of this study is to assess the efficacy of cognitive behavioral therapy for patients with trichotillomania.
Following entry into the study, subjects will be randomized into a cognitive behavioral therapy (CBT) or a minimized attention control (MAC) condition. Subjects will be assessed with the Acceptance and Action Questionnaire (AAQ), the Affective Regulation Rating (ARR), the Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), the Difficulties in Emotion Regulation Scale (DERS), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health Trichotillomania Severity Scale(NIMH-TSS), the Generalized Expectancy for Negative Mood Regulation Scale (NMR), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult Version (MIST-A), the Positive and Negative Affect Scale (PANAS), the Quality of Life Inventory (QOLI), the Readiness to Change Hairpulling Behavior (RCHPB), the Self-Esteem Scale (SES), the Skin Picking Scale (SPS) and the Scales of Psychological Well-Being (SPWB). Subject randomization to a treatment arm will be determined by a random number generator.
Subject change scores will be assessed for the above scales.
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)
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
- •primary DSM-IV diagnosis of TTM
- •outpatients who are 18 or older
- •a minimum MGHHPS total scale score of 10
- •a minimum TTM symptom duration of 1 year with no significant remissions (as defined by complete abstinence of hair extraction for a 2-week period during the prior 6 months)
排除标准
- •presence of a serious psychiatric condition including mental retardation, psychosis, pervasive developmental disorder, organic mental disorders, manic episode, ADHD, suicidality, lifetime alcohol or substance dependence, or alcohol or substance abuse within the past 3 months
- •presence of a serious medical condition that would limit ability to routinely attend sessions and complete homework assignments
- •individual or group psychotherapy (not addressing TTM) that has not been ongoing for the past 3 months and/or without intent to continue same treatment during study tenure)
- •previous CBT for TTM
- •involvement in other treatment for TTM
- •psychotropic medication that has not been stable for 3 months prior to study enrollment and/or without intent to continue same medication regimen during study tenure)
结局指标
主要结局
NIMH Trichotillomania Impairment Scale (NIMH-TIS)
时间窗: Baseline, weekly visits, follow-up
Massachusetts General Hospital Hair Pulling Scale (MGHHPS)
时间窗: Baseline, weekly visits, follow-up
NIMH Trichotillomania Severity Scale (NIMH-TSS)
时间窗: Baseline, weekly visits, follow-up
次要结局
未报告次要终点
研究者
Nancy J. Keuthen
Nancy J. Keuthen, Ph.D
Massachusetts General Hospital