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Clinical Trials in the USA / NCT07224126
Recruiting Not applicable

Technology Assisted Treatment of Trichotillomania: Open Trial

NCT07224126 · tracked via the Priya Life Science USA tracker
Sponsor
HabitAware Inc
Phase
Not applicable
Started
2025-09-15
Last updated
2025-11-10

Condition(s) studied

Trichotillomania

Investigational drug(s) / intervention(s)

Keen2 Predictive Awareness Bracelet

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Change in Trichotillomania Symptom Severity (NIMH-TSS) — Baseline, Week 4, and Week 8
    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.

Trial sites (1)

FacilityCityRegionStatus
Department of Psychological Sciences Kent Ohio Recruiting

More HabitAware Inc. trials in the USA

Technology Assisted Treatment for Trichotillomania Recruiting

Other trials for the same condition

Technology Assisted Treatment for Trichotillomania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224126 on ClinicalTrials.gov ↗ ← All trials in the USA