NCT04241120

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

January 21, 2020

Results QC Date

August 2, 2022

Last Update Submit

February 28, 2023

Conditions

Trichotillomania

Keywords

Hair Pulling DisorderBody-Focused Repetitive BehaviorsTrichotillomania

Outcome Measures

Primary Outcomes (1)

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

    Measured via post-treatment surveys.

    Four weeks

Secondary Outcomes (3)

  • Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.

    Four weeks

  • Number of Participants That Can Implement HRT Procedures With 80% Accuracy

    Four weeks

  • Number of Participants With 30% Improvement in Clinical Symptoms

    Four weeks

Study Arms (2)

Experimental group - HabitAware condition

EXPERIMENTAL

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

Control group - reminder bracelet condition

PLACEBO COMPARATOR

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

Interventions

Device and app system designed for participant to self-administer Habit Reversal TrainingBEHAVIORAL

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.

Experimental group - HabitAware condition
Reminder bracelet control conditionBEHAVIORAL

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.

Control group - reminder bracelet condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently receiving psychotherapy
  • Other psychiatric condition requiring more immediate care
  • Have previously used any behavior awareness devices (e.g. Keen)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HabitAware, Inc.

Saint Louis Park, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Results Point of Contact

Title
Sameer Kumar
Organization
HabitAware
sameer@habitaware.com
2489904720

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

January 16, 2020

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

March 27, 2023

Results First Posted

March 27, 2023

Record last verified: 2023-02

Locations

US(1)