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Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

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ClinicalTrials.gov Identifier: NCT01654523
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph Himle, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 10, 2012
First Posted Date  ICMJE July 31, 2012
Results First Submitted Date  ICMJE January 28, 2016
Results First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE January 2005
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment [ Time Frame: Baseline to post treatment; typically over 9 weeks ]
Measures severity of trichotillomania. Total score ranges from 0 (none) to 28 (severe). Mean change is determined by score at baseline minus score after treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Awareness Enhancement and Monitoring Device (AEMD) [ Time Frame: 1/1/2005 - 1/1/2013 (8 years) ]
Participant use of the AEMD will be electronically monitored via the AEMD's internal date/time tracking capabilities.
Change History Complete list of historical versions of study NCT01654523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trichotillomania
Intervention  ICMJE Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Other Name: AEMD
Study Arms  ICMJE Treatment arm
Open trial with no randomization
Intervention: Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2012)
40
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01654523
Other Study ID Numbers  ICMJE HUM00050426
2R42MH077362-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joseph Himle, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Joseph A Himle, PhD University of Michigan
PRS Account University of Michigan
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP