Technology Assisted Treatment of Trichotillomania: Open Trial

Technology Assisted Treatment for Trichotillomania: Open Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: Keen2 Predictive Awareness Bracelet

Detailed Description

This single-arm study is designed to test the feasibility and preliminary behavioral impact of a digital awareness intervention for trichotillomania. Participants aged 18 and older who report recurrent hair-pulling will receive a Keen2 bracelet and companion mobile app for an eight-week period.

Phase 1 (Weeks 1-4): Participants will use the device to detect pulling episodes and will record contextual information (such as time of day, emotional state, and environmental triggers) in the app following each detection.

Phase 2 (Weeks 5-8): Using data from the first phase, the system will deliver individualized predictive vibration alerts when behavioral patterns suggest increased risk of pulling. Alerts correspond to three intervention domains: (1) Stimulus control (reducing environmental cues), (2) Competing response training (engaging hands in alternative actions), and (3) Coping strategies (implementing relaxation or cognitive techniques).

Primary outcomes include usability, adherence, and changes in hair-pulling severity measured by the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to week 8, with a follow up at week 12. Secondary outcomes include knowledge of interventional domains as well as qualitative feedback on device helpfulness.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Flessner, PhD; Phone Number: (330) 672-2200; Email: anxiety@kent.edu

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Recruiting
      • Department of Psychological Sciences
      • Contact: Christopher Flessner, PhD; Phone Number: (330) 672-2200; Email: anxiety@kent.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HabitAware Inc.
• Collaborators: National Institute of Mental Health (NIMH); Kent State University

Publications and helpful links

Helpful Links

• Link to KSU page describing the study

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): January 9, 2026
• Study Completion (Estimated): January 9, 2026

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: trichotillomania; hair pulling disorder; BFRB; Body-Focused Repetitive Behavior; trich
• Additional Relevant MeSH Terms: Mental Disorders; Infections; Protozoan Infections; Parasitic Diseases; Anxiety Disorders; Obsessive-Compulsive Disorder; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania; Trichomonas Infections
• Other Study ID Numbers: 1943; R44MH114773 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No