Technology Assisted Treatment for Trichotillomania
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)
研究概览
简要总结
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
详细描述
Trichotillomania is characterized by recurrent hair pulling despite repeated attempts to stop, resulting in hair loss as well as significant distress and impairment. Behavior therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior (i.e., competing response) and other behavioral strategies (e.g., stimulus control) are efficacious. In this randomized control trial, we are testing the preliminary efficacy of two digital health interventions for adults with TTM (N=90). Participants will be randomly assigned (50/50 chance) to receive 8 weeks of (a) a digital behavior therapy that includes a wrist worn motion detection device to enhance awareness and a companion mobile application that provides psychoeducation, awareness training (e.g., self-monitoring), and behavioral strategy suggestions or (b) a digital general wellness intervention that includes a reminder bracelet (i.e., a wrist-worn visual reminder not to pull) accompanied by a smartphone app that includes general context logging and delivery of general health tips.
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
- •18 years of age or older (criterion 1a) with a diagnosis of TTM focused on primary hair pulling location(s) above the neck (e.g., scalp, eyebrows, eye lashes, beard) (criterion 1b).
- •English language fluency (criterion 2).
- •Report no current pharmacological intervention targeting TTM symptoms OR a 6-week course of the intervention without change in dosage and intent for that dosage to remain stable for the 12 weeks of this trial (criterion 3a).
- •Report no current psychosocial intervention targeting TTM (criterion 3b)
- •4. Reliable and consistent access to the internet and/or mobile device permitting the participant to meet with someone virtually for 90 min.
- •5. Owns a mobile phone running on Apple's operating system (iOS 6+)
- •Identifies a support person that is able to be contacted if an emergency arises.
排除标准
- •Current suicidal/homicidal ideation, intent, or plan (criterion 1a) or a diagnosis of another psychiatric condition that may impede a participant's ability to fully utilize the app (e.g., psychotic disorder, eating disorder, moderate to severe major depressive disorder [defined by meeting diagnostic criteria on the MINI and a score >13 on DASS-21]) (criterion 1b)
- •Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.
- •Residing outside the United States
研究组 & 干预措施
Reminder bracelet and health tips app
8-week intervention involving a wrist-worn reminder device (non-vibrating bracelet) and accompanying smartphone app that prompts for general context logging and delivers general health tips.
干预措施: Reminder bracelet (Device)
Reminder bracelet and health tips app
8-week intervention involving a wrist-worn reminder device (non-vibrating bracelet) and accompanying smartphone app that prompts for general context logging and delivers general health tips.
干预措施: Health Reminders App (Behavioral)
Keen2 bracelet and app
8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.
干预措施: Keen2 bracelet (Device)
Keen2 bracelet and app
8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.
干预措施: Keen2 app (Behavioral)
结局指标
主要结局
Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)
时间窗: Eight weeks
Scores on the NIMH Trichotilomania Severity Scale (NIMH-TSS), a clinician-administered assessment of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. The NIMH-TSS is a 5-item clinician rated measure of TTM severity ranging from 0-25, with higher scores indicating more severe symptoms.
次要结局
- Self-reported trichotillomania (TTM) severity at endpoint (week 8)(8 weeks)