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Technology Assisted Treatment for Trichotillomania

Primary Purpose

Trichotillomania

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

Reminder bracelet and journaling app control condition

About this trial

This is an interventional treatment 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:

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)

Sites / Locations

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

Outcomes

Primary Outcome Measures

Improvement in clinical symptoms amongst participants

Demonstrated improvement in clinical symptoms on the MGH-HPS and/or NIMH-TSS for those in the HabitAware condition.

Secondary Outcome Measures

Full Information

NCT ID

NCT05118633

First Posted

November 2, 2021

Last Updated

February 28, 2023

Sponsor

HabitAware Inc.

Collaborators

Kent State University

1. Study Identification

Unique Protocol Identification Number

NCT05118633

Brief Title

Technology Assisted Treatment for Trichotillomania

Official Title

Technology Assisted Treatment for Trichotillomania

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2024 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HabitAware Inc.

Collaborators

Kent State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

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 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).

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

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

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

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Improvement in clinical symptoms amongst participants

Description

Demonstrated improvement in clinical symptoms on the MGH-HPS and/or NIMH-TSS for those in the HabitAware condition.

Time Frame

Eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sameer Kumar, BS

Phone

248-990-4720

sameer@habitaware.com

12. IPD Sharing Statement

Learn more about this trial

Technology Assisted Treatment for Trichotillomania

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