Technology Assisted Treatment for Trichotillomania

Trichotillomania Clinical Trial

Official title:

Technology Assisted Treatment for Trichotillomania

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05118633
• Other study ID #: R44MH114773
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2023
• Source: HabitAware Inc.
• Contact: Sameer Kumar, BS
• Phone: 248-990-4720
• Email: sameer[@]habitaware.com
• 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 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Trichotillomania

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HabitAware Inc.	Kent State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Eight weeks