Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

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Brief Title

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Official Title

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Brief Summary

      The goals of the study are to further design, develop, and test an awareness enhancement and
      monitoring device, which will be used in the self-awareness training and general treatment of
      patients with compulsive hair-pulling behaviors, or trichotillomania.
    

Detailed Description

      DESCRIPTION (provided by applicant): The goal of the proposed research is to further refine
      and evaluate an inconspicuous, awareness- enhancement and monitoring device (AEMD) which will
      assist the treatment of trichotillomania (TTM). TTM is associated with significant
      impairments in social functioning and often has a profound negative impact on self- esteem
      and well being. Conservative estimates suggest that 0.6% percent of the US population, or
      about 1.8 million people, meet full diagnostic criteria for TTM and approximately 7.5 million
      US residents have significant hair pulling problems. Of those treated, 60% to 70% are wholly
      or partially refractory to standard behavioral and pharmacological treatments and could
      therefore potentially benefit from this device. Best practice treatment for TTM involves a
      form of behavioral therapy known as habit reversal therapy (HRT). HRT requires persons with
      TTM to be aware of their hair pulling behaviors, yet the majority of persons with TTM pull
      most of their hair outside of their awareness. HRT also requires TTM sufferers to record the
      frequency and duration of their hair pulling behaviors yet it is impossible for a person to
      monitor behaviors that they are unaware of. Our Phase I efforts have produced a prototype
      device (AEMD) that solves these two problems. The prototype AEMD signals the TTM sufferer if
      their hand approaches their hair, thereby bringing pulling-related behavior into awareness.
      The prototype AEMD also logs the time, date, duration, and user classification of hair
      pulling related events. Our published pilot study and subsequent investigations establish
      that the prototype AEMD successfully alerts TTM sufferers to pulling-related behaviors and
      monitors TTM-related behavior in a laboratory setting. With respect to technological
      innovation, this project has the potential to develop the first available miniaturized,
      wearable, patient interactive, real-time data collecting and proximity-sensing device that
      both alerts sufferers to the presence of mental illness symptoms as they occur and keeps
      track of the frequency and intensity of the problem. The patented technologies developed for
      the AEMD have the potential to be of great value for a range of other health/mental health
      conditions or industrial applications. Our overall Phase II aim is to further refine the AEMD
      and to evaluate its acceptance and utility when used in an open trial course of
      professionally-led habit reversal therapy. It is hypothesized that the AEMD will be
      enthusiastically accepted by TTM sufferers and their clinicians and that it will perform as
      designed during the clinical trial. The Phase II AEMD will include a bracelet(s)/watch to be
      worn on each wrist, another element to be placed at the rear base of the neck, and a
      pager-like alert device to be worn at the belt-line or in a pocket. The AEMD, if found to be
      useful and effective, has the potential to significantly reduce the symptoms of TTM and its
      associated functional impairments. The AEMD also has great potential to improve assessment
      and monitoring of TTM behaviors which could be invaluable to clinicians planning treatment
      and to researchers evaluating the efficacy of various treatment strategies.

      We discovered that the electronic monitoring capability of the AEMD did not function
      properly. Therefore we cannot report time spent pulling using the electronic device. We
      relied on self-report instruments to assess the impact of the psychotherapy combined with
      with the device on the severity of trichotillomania.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment


Condition

Trichotillomania

Intervention

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Study Arms / Comparison Groups

 Treatment arm
Description:  Open trial with no randomization

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

33

Start Date

January 2005

Completion Date

June 2014

Primary Completion Date

June 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Must have active hair pulling over the month prior to enrollment

          -  Must have noticeable hair loss

          -  Must experience significant distress related to Trichotillomania

          -  Must primarily pull from the head area

          -  Subjects taking medications will be included

          -  Must be able to read/write English

        Exclusion Criteria:

          -  Current substance use diagnosis

          -  Chronic neurological disorder (other than chronic tics)

          -  Mental retardation

          -  Schizophrenia and other psychotic disorders

          -  Bipolar I disorder

          -  Prominent suicidal/homicidal ideation with imminent risk
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Joseph A Himle, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01654523

Organization ID

HUM00050426

Secondary IDs

2R42MH077362-02

Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Joseph A Himle, PhD, Principal Investigator, University of Michigan


Verification Date

June 2016