Technology Assisted Treatment for Trichotillomania
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Keen2 bracelet, Reminder bracelet, Keen2 app, Health Reminders App.
- Who it may be relevant to
- Registry conditions: Trichotillomania. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
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.
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]
Secondary outcome measures (1)
- Self-reported trichotillomania (TTM) severity at endpoint (week 8) [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Department of Psychological Sciences — Kent
Identifiers
NCT: NCT05118633 · R44MH114773