Technology Assisted Treatment for Trichotillomania

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 and a companion mobile application was created. In this study, we will test the initial efficacy of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).

Official Title
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Technology Assisted Treatment for Trichotillomania

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 and Stimulus Control
* Behavioral: Reminder bracelet and journaling app control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to participate; Current diagnosis of TTM (as assessed via TDI); Regular access to a smartphone with GPS capabilities (i.e., available for completing assessment probes throughout the day); 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: Treatment
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 and Stimulus Control<br>* Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training and Stimulus Control. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania, as well as receive stimulus control reminders.<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, as well as being asked to journal about their daily activities in an app. | Behavioral: Reminder bracelet and journaling app 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. They will also be instructed to journal in an app on their phone several times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in clinical symptoms amongst participants | Demonstrated improvement in clinical symptoms on the MGH-HPS and/or NIMH-TSS for those in the HabitAware condition. | Eight 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