Technology Assisted Treatment of Trichotillomania: Open Trial
NCT ID: NCT07224126
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-09-15
2026-01-09
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Kent State University
OTHER
HabitAware Inc.
INDUSTRY
Responsible Party
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Locations
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Department of Psychological Sciences
Kent, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Christopher Flessner, PhD
Role: primary
Related Links
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Link to KSU page describing the study
Other Identifiers
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1943
Identifier Type: -
Identifier Source: org_study_id