Technology Assisted Treatment for Trichotillomania

NCT05118633 | Not Yet Recruiting DMC

• 1 other identifier: R44MH114773
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trichotillomania

Keywords

Hair Pulling Disorder; Body-Focused Repetitive Behaviors; Trichotillomania; habit reversal training

Outcome Measures

Primary Outcomes (1)

• 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.

  Eight weeks

Secondary Outcomes (1)

• Self-reported trichotillomania (TTM) severity at endpoint (week 8)

  8 weeks

Study Arms (2)

Keen2 bracelet and app

EXPERIMENTAL

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

Reminder bracelet and health tips app

PLACEBO COMPARATOR

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

Interventions

Keen2 bracelet DEVICE

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.

Keen2 bracelet and app

Reminder bracelet DEVICE

Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.

Reminder bracelet and health tips app

Keen2 app BEHAVIORAL

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.

Keen2 bracelet and app

Health Reminders App BEHAVIORAL

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.

Reminder bracelet and health tips app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \. Reliable and consistent access to the internet and/or mobile device permitting the participant to meet with someone virtually for 90 min.
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HabitAware Inc.: lead
• Kent State University: collaborator

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Central Study Contacts

Sameer Kumar, BS

CONTACT

248-990-4720; sameer@habitaware.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 12, 2021
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02