NCT04241120

Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Completed NA Results posted Last updated 27 March 2023

What this trial tests

NA trial testing Device and app system designed for participant to self-administer Habit Reversal Training in Trichotillomania in 15 participants. Completed in 4 March 2020.

Timeline

16 January 2020

Primary endpoint
4 March 2020

4 March 2020

Quick facts

Lead sponsor	HabitAware Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	15
Start date	16 January 2020
Primary completion	4 March 2020
Estimated completion	4 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Device and app system designed for participant to self-administer Habit Reversal Training
• Reminder bracelet control condition

Conditions studied

• Trichotillomania — all drugs for Trichotillomania →

Sponsor

HabitAware Inc.

Who can join

18 and older, any sex, with Trichotillomania. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. Primary · Four weeks

Measured via post-treatment surveys.

Group	Value	95% CI
Experimental Group - HabitAware Condition	9
Control Group - Reminder Bracelet Condition	0

Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. Secondary · Four weeks

Measured by post treatment survey results

Group	Value	95% CI
Experimental Group - HabitAware Condition	10
Control Group - Reminder Bracelet Condition	0

Number of Participants That Can Implement HRT Procedures With 80% Accuracy Secondary · Four weeks

Measured by trained clinician observing the participant perform the procedures

Group	Value	95% CI
Experimental Group - HabitAware Condition	4
Control Group - Reminder Bracelet Condition	0

Number of Participants With 30% Improvement in Clinical Symptoms Secondary · Four weeks

Measured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions.

Group	Value	95% CI
Experimental Group - HabitAware Condition	6
Control Group - Reminder Bracelet Condition	3

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot trial of a technology assisted treatment for trichotillomania.
   Stiede JT, Woods DW, Idnani AK, Pritchard J, et al · · 2022 · cited 2× · PMID 37305101 · DOI 10.1016/j.jocrd.2022.100726