Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Himle, University of Michigan
ClinicalTrials.gov Identifier:
NCT01654523
First received: May 10, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Trichotillomania
Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Awareness Enhancement and Monitoring Device (AEMD) [ Time Frame: 1/1/2005 - 1/1/2013 (8 years) ] [ Designated as safety issue: No ]
    Participant use of the AEMD will be electronically monitored via the AEMD's internal date/time tracking capabilities.


Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
    Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
    Other Name: AEMD
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654523

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Joseph A Himle, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Joseph Himle, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01654523     History of Changes
Other Study ID Numbers: HUM00050426
Study First Received: May 10, 2012
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
Trichotillomania

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014