NCT04559750已完成不适用
Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Massachusetts General Hospital Hairpulling Scale
研究概览
简要总结
The primary aim of the study is to test the feasibility, safety and efficacy of a manual based, Internet-delivered, behavior therapy (I-BT) for trichotillomania and skin picking disorder.
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
- •Primary diagnosis of trichotillomania and/or skin picking disorder according to DSM-5
- •Living in Sweden with a Swedish personal identification number
- •Able to participate in study assessment in Swedish and understand Swedish text
- •Have regular access to a computer with Internet access and skills to use Internet
- •Signed informed consent
- •Outpatient
排除标准
- •Psychotropic medication changes that can affect symptoms of trichotillomania or skin picking disorder within 2 months prior to treatment
- •Other ongoing psychological treatments that could affect symptoms of trichotillomania or skin picking disorder
- •Completed CBT for trichotillomania or skin picking disorder within the last 24 months
- •Ongoing substance dependence or misuse
- •Lifetime bipolar disorder or psychosis
- •Suicidal ideation (a score of 5 points or higher on item 9 on the self-reported Montgomery-Åsberg depression rating scale
- •Psychiatric comorbidity that could severely jeopardize treatment participation
结局指标
主要结局
The Massachusetts General Hospital Hairpulling Scale
时间窗: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
A self-report instrument for assessing repetitive hairpulling. The scale consists of seven items, rated for severity from 0 to 4 which assess urges to pull, actual pulling, perceived control, and associated distress.
The Skin Picking Scale - Revised
时间窗: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
A 6-item self-report measure of skin picking disorder severity.
次要结局
- Montgomery Åsberg Depression Rating Scale Self Rate(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
- Acceptance and Action Questionnaire(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
- The Skin Picking Impact Scale(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
- The NIMH Trichotillomania Symptom Severity Scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
- The NIMH Trichotillomania a Impairment Scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
- Treatment credibility scale.(Scores at mid-treatment (week 5) and post-treatment (week 10).)
- Clinical global impression - severity scale.(Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.)
- Negative events questionnaire (NEQ).(Ratings at post-treatment (week 10).)
- Sheehan Disability Scale(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
- EuroQol 5D, (EQ5D).(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
- Working Alliance Inventory - Short Form.(Scores at mid-treatment (week 5) and post-treatment (week 10).)
- Global Assessment of functioning scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
- Acceptance and Action Questionnaire for Trichotillomania(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
- Patient Health Questionnaire 9.(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
- Client Satisfaction Questionnaire-8.(Scores at post-treatment (week 10).)
- Clinical global impression - improvement scale.(Ratings at post-treatment (week 10) and at 12-month follow-up.)
研究者
Volen Ivanov
Principal Investigator
Karolinska Institutet
研究点 (1)
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