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.
Reminder bracelet: Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
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.
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.
Study summary
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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).
2. English language fluency (criterion 2).
3. 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).
4. 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.
Exclusion Criteria:
1. 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)
2. Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.
3. Residing outside the United States
Primary outcome measure(s)
Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8) — 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.
Trial sites (1)
Facility
City
Region
Status
Department of Psychological Sciences
Kent
Ohio
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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