NCT05118633 · HabitAware Inc.
Technology Assisted Treatment for Trichotillomania
What this study is about
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomly assigned trial design.
View original scientific description
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
Interventions
DEVICE
Keen2 bracelet
Participants will receive an awareness bracelet (Keen2) which vibrates upon detection of hair pulling motion, supporting behavior therapy for hair pulling delivered by the Keen2 app.
DEVICE
Reminder bracelet
Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
BEHAVIORAL
Keen2 app
Participants will be given access to a smartphone app. The bracelet and app work together to implement key features of habit reversal training for TTM, including psychoeducation, awareness training, competing response training, and personalized just-in-time stimulus control and other behavioral strategy reminders.
BEHAVIORAL
Health Reminders App
Participants will be given access to a smartphone app that will prompt them to log their context (e.g., location and activity) throughout the day and provide general health tips.
Primary outcome measures
Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)
Time frame: Eight weeks
Scores on the NIMH Trichotilomania Severity Scale (NIMH-TSS), a clinician-administered assessment of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. The NIMH-TSS is a 5-item clinician rated measure of TTM severity ranging from 0-25, with higher scores indicating more severe symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- English language fluency (criterion 2).
- 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).
- 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
- 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)
- Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.
- Residing outside the United States
Where
- Kent, Ohio
Collaborators
Kent State University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations