Technology Assisted Treatment for Trichotillomania

Обзор

The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.

Подробное описание

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.

Вмешательства

• Устройство Keen2 bracelet
  Participants will receive an awareness bracelet (Keen2) which vibrates upon detection of hair pulling motion, supporting behavior therapy for hair pulling delivered by the Keen2 app.
• Устройство Reminder bracelet
  Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
• Поведенческое Keen2 app
  Participants will be given access to a smartphone app. The bracelet and app work together to implement key features of habit reversal training for TTM, including psychoeducation, awareness training, competing response training, and personalized just-in-time stimulus control and other behavioral strategy reminders.
• Поведенческое Health Reminders App
  Participants will be given access to a smartphone app that will prompt them to log their context (e.g., location and activity) throughout the day and provide general health tips.

Первичные конечные точки

• Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8) [Срок оценки: Eight weeks]

Вторичные конечные точки (1)

• Self-reported trichotillomania (TTM) severity at endpoint (week 8) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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+) 6. Identifies a support person that is able to be contacted if an emergency arises.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Department of Psychological Sciences — Kent

Идентификаторы

NCT: NCT05118633 · R44MH114773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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