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Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Primary Purpose

Trichotillomania

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device and app system designed for participant to self-administer Habit Reversal Training
Reminder bracelet control condition
Sponsored by
HabitAware Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trichotillomania focused on measuring Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • HabitAware, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group - HabitAware condition

Control group - reminder bracelet condition

Arm Description

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.

This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
Measured by post treatment survey results
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
Measured by trained clinician observing the participant perform the procedures
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.

Full Information

First Posted
January 21, 2020
Last Updated
February 28, 2023
Sponsor
HabitAware Inc.
Collaborators
Marquette University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04241120
Brief Title
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
Official Title
Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HabitAware Inc.
Collaborators
Marquette University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group - HabitAware condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group - reminder bracelet condition
Arm Type
Placebo Comparator
Arm Description
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Intervention Type
Behavioral
Intervention Name(s)
Device and app system designed for participant to self-administer Habit Reversal Training
Intervention Description
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
Intervention Name(s)
Reminder bracelet control condition
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.
Description
Measured via post-treatment surveys.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
Description
Measured by post treatment survey results
Time Frame
Four weeks
Title
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
Description
Measured by trained clinician observing the participant perform the procedures
Time Frame
Four weeks
Title
Number of Participants With 30% Improvement in Clinical Symptoms
Description
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.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
HabitAware, Inc.
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States

12. IPD Sharing Statement

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Feasibility Study for Treating Trichotillomania With Wearable Device and App System

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