Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Study Overview
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Brief Summary
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Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).

Official Title
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Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training

Conditions
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Trichotillomania

Intervention / Treatment
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* Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training
* Behavioral: Reminder bracelet control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Speak fluent English Current diagnosis of TTM Score above the normative mean on the automatic pulling subscale of the MIST-A Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks) Exclusion Criteria: Currently receiving psychotherapy Other psychiatric condition requiring more immediate care Have previously used any behavior awareness devices (e.g. Keen)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group - HabitAware condition<br>This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training. | Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training<br>* Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.<br>|
| Placebo Comparator: Control group - reminder bracelet condition<br>This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull. | Behavioral: Reminder bracelet control condition<br>* Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. | Measured via post-treatment surveys. | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | Measured by post treatment survey results | Four weeks | 
| Number of Participants That Can Implement HRT Procedures With 80% Accuracy | Measured by trained clinician observing the participant perform the procedures | Four weeks | 
| Number of Participants With 30% Improvement in Clinical Symptoms | Measured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions. | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania