Keen2 bracelet to increase awareness and reduce hair-pulling in adults with trichotillomania
Technology Assisted Treatment for Trichotillomania: Open Trial
This study will try a Keen2 wearable bracelet to help adults with trichotillomania notice and reduce hair-pulling by detecting episodes and sending personalized vibration alerts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HabitAware Inc. Industry-sponsored |
| Locations | 1 site (Kent, Ohio) |
| Trial ID | NCT07224126 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm feasibility study gives adults with trichotillomania a Keen2 bracelet and companion app for eight weeks to test a digital awareness intervention. During the first four weeks participants wear the device and log contextual details after each detected pulling episode. In weeks five through eight the system uses those data to deliver individualized predictive vibration alerts tied to stimulus control, competing responses, and coping strategies. Primary outcomes include usability, adherence, and change in self-reported pulling severity (MGH-HPS) from baseline to week 8 with a week 12 follow-up.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of trichotillomania who speak English, own an iPhone, have internet access, are not changing TTM treatments (or have been stable for 6+ weeks), and can identify an emergency contact are ideal candidates.
Not a fit: People with active suicidal or homicidal ideation, unstable psychiatric conditions, those who do not use an iPhone, or those currently changing pharmacologic or psychosocial TTM treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the bracelet could help people with trichotillomania become more aware of triggers and reduce pulling by providing timely reminders and coping prompts.
How similar studies have performed: Small feasibility and pilot studies of wearable awareness devices for body-focused repetitive behaviors have shown promise for improving awareness, but randomized controlled evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Kent, Ohio
- Department of Psychological Sciences — Kent, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Christopher Flessner, PhD
- Email: anxiety@kent.edu
- Phone: (330) 672-2200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.