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Feasibility Study for Treating Trichotillomania With Wearable Device and App System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241120
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
Marquette University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
HabitAware Inc.

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
Trichotillomania Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training Behavioral: Reminder bracelet control condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Speak fluent English
  3. Current diagnosis of TTM
  4. Score above the normative mean on the automatic pulling subscale of the MIST-A
  5. Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241120


Locations
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United States, Minnesota
HabitAware, Inc.
Saint Louis Park, Minnesota, United States, 55426
Sponsors and Collaborators
HabitAware Inc.
Marquette University
National Institute of Mental Health (NIMH)
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Responsible Party: HabitAware Inc.
ClinicalTrials.gov Identifier: NCT04241120    
Other Study ID Numbers: 31257150
R43MH114773 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HabitAware Inc.:
Hair Pulling Disorder
Body-Focused Repetitive Behaviors
Trichotillomania
Additional relevant MeSH terms:
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Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders