Recruiting

Digital Health Interventions

Sponsor:

HabitAware Inc.

Code:

NCT05118633

Conditions

Trichotillomania

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Keen2 bracelet

Reminder bracelet

Keen2 app

Health Reminders App

Study Details

Brief summary:

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

Conditions

Trichotillomania

Study ID

NCT05118633

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Keen2 bracelet and app

8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.

placebo comparator: Reminder bracelet and health tips 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Department of Psychological Sciences

Recruiting

Kent, Ohio, United States, 44242

Contacts

Christopher Flessner, PhD

(330) 672-2200anxiety@kent.edu

More Information

Sponsor

HabitAware Inc.

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HabitAware Inc. on 2026-06-02.