An interventional study of Keen2 bracelet and Reminder bracelet in Trichotillomania, sponsored by HabitAware Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by HabitAware Inc. · Not applicable, Interventional, and Treatment
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
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.
44 studies on the registry are indexed under Trichotillomania; 7 are open to participants now.
This study's planned enrollment of 90 is above the median of 38 across 42 interventional studies indexed under Trichotillomania.
Browse Trichotillomania studies →HabitAware Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.
Device: Keen2 bracelet · Behavioral: Keen2 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.
Device: Reminder bracelet · Behavioral: Health Reminders App
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.
Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
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.
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.
Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)
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.
Time frame: Eight weeks
Self-reported trichotillomania (TTM) severity at endpoint (week 8)
Scores on the Massachusetts General Hospital Hair Pulling Scale (MGH-HS), a validated and widely used 7-item Likert self-report measure of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. MGH-HS scores range from 0 to 28, with higher scores corresponding with more severe TTM symptoms.
Time frame: 8 weeks
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HabitAware Inc.