Technology Assisted Treatment of Trichotillomania: Open Trial

Phase

N/A

Condition

Hair Loss

Scalp Disorders

Alopecia

Treatment

Keen2 Predictive Awareness Bracelet

Clinical Study ID

NCT07224126

1943

R44MH114773

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 TTMsymptoms OR a6-week course of either intervention modality without change infrequency,intensity, or dosage (criterion 3)
Reliable and consistent access to the internet and/or mobile device permitting theparticipant 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 Keen2deviceand setting up Keen2 system.

Exclusion

Exclusion Criteria:

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

Study Design

Keen2 Predictive Awareness Bracelet

September 15, 2025

January 09, 2026

Study 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.

Connect with a study center

Department of Psychological Sciences
Kent 5159537, Ohio 5165418 44242
United States
Active - Recruiting

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