Technology Assisted Treatment of Trichotillomania: Open Trial

NCT07224126 | Recruiting

• 2 other identifiers: 1943R44MH114773
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Trichotillomania Symptom Severity (NIMH-TSS)

  The primary outcome is the change in total score on the NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) from baseline to week 8. The NIMH-TSS is a clinician-rated scale assessing the frequency, intensity, and distress associated with hair-pulling behavior. Higher scores indicate greater symptom severity. A reduction in score reflects improvement.

  Baseline, Week 4, and Week 8

Study Arms (1)

Single-Arm Intervention: Keen2 Predictive Awareness Bracelet

EXPERIMENTAL

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).

Behavioral: Keen2 Predictive Awareness Bracelet

Interventions

Keen2 Predictive Awareness Bracelet BEHAVIORAL

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.

Single-Arm Intervention: Keen2 Predictive Awareness Bracelet

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 (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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• HabitAware Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• Kent State University: collaborator

Study Sites (1)

Department of Psychological Sciences

Kent, Ohio, 44242, United States

RECRUITING

Related Links

• Link to KSU page describing the study

MeSH Terms

Conditions

Trichotillomania; Trichomonas Infections

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Protozoan Infections; Parasitic Diseases; Infections

Central Study Contacts

Christopher Flessner, PhD

CONTACT

(330) 672-2200; anxiety@kent.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: September 15, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)