Trials / Not Yet Recruiting
Not Yet RecruitingNCT05118633
Technology Assisted Treatment for Trichotillomania
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- HabitAware Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | Reminder bracelet | Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull. |
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-09-01
- Completion
- 2026-10-01
- First posted
- 2021-11-12
- Last updated
- 2026-02-23
Source: ClinicalTrials.gov record NCT05118633. Inclusion in this directory is not an endorsement.