Technology Assisted Treatment for Trichotillomania

The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.

Study Overview

• Status: Recruiting
• Conditions: Trichotillomania
• Intervention / Treatment: Device: Keen2 bracelet; Behavioral: Keen2 app; Device: Reminder bracelet; Behavioral: Health Reminders App

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sameer Kumar, BS; Phone Number: 248-990-4720; Email: sameer@habitaware.com

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Recruiting
      • Department of Psychological Sciences
      • Contact: Christopher Flessner, PhD; Phone Number: (330) 672-2200; Email: anxiety@kent.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keen2 bracelet and app; 8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.	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.; 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.
Placebo Comparator: Reminder bracelet and health tips app; 8-week intervention involving a wrist-worn reminder device (non-vibrating bracelet) and accompanying smartphone app that prompts for general context logging and delivers general health tips.	Device: Reminder bracelet; Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)	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.	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported trichotillomania (TTM) severity at endpoint (week 8)	Scores on the Massachusetts General Hospital Hair Pulling Scale (MGH-HS), a validated and widely used 7-item Likert self-report measure of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. MGH-HS scores range from 0 to 28, with higher scores corresponding with more severe TTM symptoms.	8 weeks

Collaborators and Investigators

• Sponsor: HabitAware Inc.
• Collaborators: Kent State University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: habit reversal training; Trichotillomania; Hair Pulling Disorder; Body-Focused Repetitive Behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: R44MH114773 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No