Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Trichotillomania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241120
• Other study ID #: 31257150
• Secondary ID: R43MH114773
• Status: Completed
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: March 4, 2020

Study information

• Verified date: February 2023
• Source: HabitAware Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Trichotillomania

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	HabitAware, Inc.	Saint Louis Park	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HabitAware Inc.	Marquette University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.	Measured by post treatment survey results	Four weeks
Secondary	Number of Participants That Can Implement HRT Procedures With 80% Accuracy	Measured by trained clinician observing the participant perform the procedures	Four weeks
Secondary	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