Technology Assisted Treatment for Trichotillomania

Sponsor
HabitAware Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05118633
Collaborator
Kent State University (Other)
70
2
15

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training and Stimulus Control
  • Behavioral: Reminder bracelet and journaling app control condition
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Technology Assisted Treatment for Trichotillomania
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Improvement in clinical symptoms amongst participants [Eight weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • HabitAware Inc.
  • Kent State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HabitAware Inc.
ClinicalTrials.gov Identifier:
NCT05118633
Other Study ID Numbers:
  • R44MH114773
First Posted:
Nov 12, 2021
Last Update Posted:
Nov 12, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by HabitAware Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 12, 2021