Technology Assisted Treatment for Trichotillomania

NCT ID: NCT05118633

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-10-31

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).

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

TREATMENT

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 and Stimulus Control

Intervention Type BEHAVIORAL

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.

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, as well as being asked to journal about their daily activities in an app.

Group Type PLACEBO_COMPARATOR

Reminder bracelet and journaling app 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. They will also be instructed to journal in an app on their phone several times per day.

Interventions

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

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.

Intervention Type BEHAVIORAL

Reminder bracelet and journaling app 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. They will also be instructed to journal in an app on their phone several times per day.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kent State University

OTHER

Sponsor Role collaborator

HabitAware Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sameer Kumar, BS

Role: CONTACT

248-990-4720

Other Identifiers

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R44MH114773

Identifier Type: NIH

Identifier Source: org_study_id

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