Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Not Applicable

Completed

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

• Registration Number: NCT04241120
• Lead Sponsor: HabitAware Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Results First Submitted: 2022-08-02
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Results First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group - reminder bracelet condition	Reminder bracelet control condition	This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Experimental group - HabitAware condition	Device and app system designed for participant to self-administer Habit Reversal Training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.	Four weeks	Measured by post treatment survey results
Number of Participants That Can Implement HRT Procedures With 80% Accuracy	Four weeks	Measured by trained clinician observing the participant perform the procedures
Number of Participants With 30% Improvement in Clinical Symptoms	Four weeks	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.

Trial Locations

Locations (1)

HabitAware, Inc.; 🇺🇸 Saint Louis Park, Minnesota, United States