Feasibility Study for Treating Trichotillomania With Wearable Device and App System

NCT ID: NCT04241120

Last Updated: 2023-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2020-03-04

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).

Detailed Description

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Conditions

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Trichotillomania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Reminder bracelet control condition

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marquette University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

HabitAware Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HabitAware, Inc.

Saint Louis Park, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R43MH114773

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31257150

Identifier Type: -

Identifier Source: org_study_id

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