Recruiting

Keen2 Bracelet

Sponsor:

HabitAware Inc.

Code:

NCT07224126

Conditions

Trichotillomania

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Keen2 Predictive Awareness Bracelet

Study Details

Brief summary:

This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will use the bracelet for eight weeks. During the first four weeks, they will wear the device and log contextual information (such as emotions, location, and activity) after each detected hair-pulling episode. Based on these data, participants will then receive tailored predictive alerts designed to support use of stimulus control, competing responses, and coping strategies. The study will assess usability, adherence, and changes in self-reported hair-pulling severity and awareness.

Conditions

Trichotillomania

Study ID

NCT07224126

Start date

Sep 15, 2025

Status verified date

Nov, 2025

Completion date

Jan 9, 2026

Anticipated

Primary completion date

Jan 9, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age (criterion 1a) with a diagnosis of TTM (criterion 1b)
  • Must reportEnglish as their primary language (criterion 2)
  • Report no current pharmacological or psychosocial intervention targeting TTM symptoms OR a6-week course of either intervention modality without change in frequency,intensity, or dosage (criterion 3)
  • Reliable and consistent access to the internet and/or mobile device permitting the participant to meet withsomeone virtually for 90 min.
  • Must report owning/access to a mobilephone running on Apple's operating system (iOS)
  • Identifies a support person that is able to be contacted is an emergency arises.
  • Agrees to allow the Kent State research team to share home address, mobile number, andalternate number/email with HabitAware, Inc., for purposes of mailing Keen2device and setting up Keen2 system.

Exclusion Criteria:

  • Current suicidal/homicidal ideation, intent, or plan
  • a diagnosis of another psychiatric condition that may impeded a participant's ability to fully utilize the app (e.g., psychotic disorder, major depressive disorder)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-Arm Intervention: Keen2 Predictive Awareness Bracelet

Participants in this single-arm study will receive a Keen2 awareness bracelet and companion mobile app for an 8-week period. During the first 4 weeks, participants will use the device to detect hair-pulling episodes and record contextual details (such as time, emotional state, activity, and location) after each detection. In the second 4 weeks, participants will receive predictive vibration alerts generated from their prior behavioral patterns. These alerts are designed to prompt preventive actions across three domains: (1) stimulus control (reducing environmental triggers), (2) competing response training (engaging hands in alternative behaviors), and (3) coping strategies (using relaxation or cognitive techniques).

Interventions

Keen2 Predictive Awareness Bracelet

The Keen2 is a wrist-worn awareness bracelet paired with a mobile app that helps individuals with trichotillomania recognize and reduce hair-pulling behavior. The bracelet uses motion sensors to detect hand movements consistent with pulling and delivers gentle vibration alerts to increase awareness. During the first four weeks, participants log contextual information about each detected episode, including emotional state, location, and activity. Based on these data, the system delivers predictive vibration alerts during weeks five through eight to prompt behavior change strategies across three domains: (1) stimulus control, (2) competing response training, and (3) coping strategies.

Primary outcome measure

  • Change in Trichotillomania Symptom Severity (NIMH-TSS) [ Time Frame: Baseline, Week 4, and Week 8 ]

Central Contacts and Locations

Central contacts

Christopher Flessner, PhD

(330) 672-2200anxiety@kent.edu

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

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • hair pulling disorder
  • BFRB
  • Body-Focused Repetitive Behavior
  • trichotillomania
  • trich

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 2025-11-10.