Feasibility Study for Treating Trichotillomania With Wearable Device and App System
|ClinicalTrials.gov Identifier: NCT04241120|
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Trichotillomania||Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training Behavioral: Reminder bracelet control condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training|
|Actual Study Start Date :||January 16, 2020|
|Actual Primary Completion Date :||March 4, 2020|
|Actual Study Completion Date :||March 4, 2020|
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.
- Percentage of participants that wore the device for 6 hours per day and more than 4 days per week. [ Time Frame: 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
- Percentage of participants that reported the device >3 on a scale of 1-5 for accuracy. [ Time Frame: 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 [ Time Frame: Four weeks ]Participants in the HabitAware condition can implement the HRT procedures at >80% accuracy.
- Number of participants with 30% improvement in clinical symptoms [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241120
|United States, Minnesota|
|Saint Louis Park, Minnesota, United States, 55426|