Feasibility Study for Treating Trichotillomania With Wearable Device and App System
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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
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
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.
|
| 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants that wore the device for 6 hours per day and more than 4 days per week. [Four weeks]
Patients report that the treatment is acceptable, both by post-treatment survey results and if at least 60% of participants wore the device for at least 6 hours per day and 4 or more days per week during the clinical trial
Secondary Outcome Measures
- Percentage of participants that reported the device >3 on a scale of 1-5 for accuracy. [Four weeks]
Patients report that the device is accurate (i.e., 60% of participants rated the device as >3 (indicating acceptable levels) for true- and false-positives
- Number of participants that can implement HRT procedures with 80% accuracy [Four weeks]
Participants in the HabitAware condition can implement the HRT procedures at >80% accuracy.
- Number of participants with 30% improvement in clinical symptoms [Four weeks]
There is a demonstrated improvement in clinical symptoms greater than 30% on the MGH-HPS and/or NIMH-TSS for those in the HabitAware conditionsaccuracy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Speak fluent English
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Current diagnosis of TTM
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Score above the normative mean on the automatic pulling subscale of the MIST-A
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Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)
Exclusion Criteria:
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Currently receiving psychotherapy
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Other psychiatric condition requiring more immediate care
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Have previously used any behavior awareness devices (e.g. Keen)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HabitAware, Inc. | Saint Louis Park | Minnesota | United States | 55426 |
Sponsors and Collaborators
- HabitAware Inc.
- Marquette University
- National Institute of Mental Health (NIMH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 31257150
- R43MH114773