Feasibility Study for Treating Trichotillomania With Wearable Device and App System

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

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 Overview

• Status: Completed
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training; Behavioral: Reminder bracelet control condition

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • HabitAware, Inc.

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group - HabitAware condition; 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; 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.
Placebo Comparator: Control group - reminder bracelet condition; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HabitAware Inc.
• Collaborators: National Institute of Mental Health (NIMH); Marquette University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Trichotillomania; Hair Pulling Disorder; Body-Focused Repetitive Behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania
• Other Study ID Numbers: 31257150; R43MH114773 (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