N/A
N=15
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
Trichotillomania
Bottom Line
View on ClinicalTrials.gov: NCT04241120 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. — 9; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device and app system designed for participant to self-administer Habit Reversal Training (Behavioral); Reminder bracelet control condition (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HabitAware Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. |
9; 0 | — |
| SECONDARY Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. |
10; 0 | — |
| SECONDARY Number of Participants That Can Implement HRT Procedures With 80% Accuracy |
4; 0 | — |
| SECONDARY Number of Participants With 30% Improvement in Clinical Symptoms |
6; 3 | — |
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).
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)
Data sourced from ClinicalTrials.gov (NCT04241120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.