Feasibility Study for Treating Trichotillomania With Wearable Device and App System

HabitAware Inc.15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Trichotillomania

Interventions

Device and app system designed for participant to self-administer Habit Reversal TrainingBEHAVIORAL

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.

Reminder bracelet control conditionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years of age or older 2. Speak fluent English 3. Current diagnosis of TTM 4. Score above the normative mean on the automatic pulling subscale of the MIST-A 5. Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks) Exclusion Criteria: 1. Currently receiving psychotherapy 2. Other psychiatric condition requiring more immediate care 3. Have previously used any behavior awareness devices (e.g. Keen)

Locations (1)

HabitAware, Inc.

Saint Louis Park, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Four weeks

Secondary Outcomes

Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.

Measured by post treatment survey results

Time frame: Four weeks

Number of Participants That Can Implement HRT Procedures With 80% Accuracy

Measured by trained clinician observing the participant perform the procedures

Time frame: 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.

Time frame: Four weeks

Data from ClinicalTrials.gov

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