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Completed

NCT Number: NCT04241120

Feasibility Study for Treating Trichotillomania With Wearable Device and App System

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).

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Key information

Conditions

Trichotillomania Anxiety Disorders Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HabitAware, Inc.

Saint Louis Park, Minnesota, 55426, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Speak fluent English
  • Current diagnosis of TTM
  • Score above the normative mean on the automatic pulling subscale of the MIST-A
  • Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)

Exclusion criteria

  • Currently receiving psychotherapy
  • Other psychiatric condition requiring more immediate care
  • Have previously used any behavior awareness devices (e.g. Keen)

Treatment and study plan

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

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.

Reminder bracelet control condition

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.

Primary outcomes

  1. Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.

    Time frame: Four weeks

    Measured via post-treatment surveys.

Secondary outcomes

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

    Time frame: Four weeks

    Measured by post treatment survey results

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

    Time frame: Four weeks

    Measured by trained clinician observing the participant perform the procedures

  3. Number of Participants With 30% Improvement in Clinical Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HabitAware Inc.

Industry

Collaborators

  • Marquette University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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