RecruitingRecruiting
Technology Assisted Treatment for Trichotillomania
NCT05118633 · HabitAware Inc.
In plain English
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About this study
Trichotillomania is characterized by recurrent hair pulling despite repeated attempts to stop, resulting in hair loss as well as significant distress and impairment. Behavior therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior (i.e., competing response) and other behavioral strategies (e.g., stimulus control) are efficacious. In this randomized control trial, we are testing the preliminary efficacy of two digital health interventions for adults with TTM (N=90). Participants will be randomly assigned (50/50 chance) to receive 8 weeks of (a) a digital behavior therapy that includes a wrist worn motion detection device to enhance awareness and a companion mobile application that provides psychoeducation, awareness training (e.g., self-monitoring), and behavioral strategy suggestions or (b) a digital general wellness intervention that includes a reminder bracelet (i.e., a wrist-worn visual reminder not to pull) accompanied by a smartphone app that includes general context logging and delivery of general health tips.
Eligibility criteria
Inclusion Criteria:
1. 18 years of age or older (criterion 1a) with a diagnosis of TTM focused on primary hair pulling location(s) above the neck (e.g., scalp, eyebrows, eye lashes, beard) (criterion 1b).
2. English language fluency (criterion 2).
3. Report no current pharmacological intervention targeting TTM symptoms OR a 6-week course of the intervention without change in dosage and intent for that dosage to remain stable for the 12 weeks of this trial (criterion 3a).
4. Report no current psychosocial intervention targeting TTM (criterion 3b)
4\. Reliable and consistent access to the internet and/or mobile device permitting the participant to meet with someone virtually for 90 min.
5\. Owns a mobile phone running on Apple's operating system (iOS 6+) 6. Identifies a support person that is able to be contacted if an emergency arises.
Exclusion Criteria:
1. Current suicidal/homicidal ideation, intent, or plan (criterion 1a) or a diagnosis of another psychiatric condition that may impede a participant's ability to fully utilize the app (e.g., psychotic disorder, eating disorder, moderate to severe major depressive disorder \[defined by meeting diagnostic criteria on the MINI and a score \>13 on DASS-21\]) (criterion 1b)
2. Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.
3. Residing outside the United States
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-05-15
Estimated completion: 2026-12-31
Last updated: 2026-06-02
Interventions
Device: Keen2 braceletDevice: Reminder braceletBehavioral: Keen2 appBehavioral: Health Reminders App
Primary outcomes
- • Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8) (Eight weeks)
Sponsor
HabitAware Inc. · industry
With: Kent State University
Contacts & investigators
ContactSameer Kumar, BS · contact · sameer@habitaware.com · 248-990-4720
All locations (1)
Department of Psychological SciencesRecruiting
Kent, Ohio, United States