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Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Primary Purpose

Trichotillomania

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring Trichotillomania

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment arm

Arm Description

Open trial with no randomization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2012
Last Updated
June 21, 2016
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01654523
Brief Title
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Official Title
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
Trichotillomania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Other
Arm Description
Open trial with no randomization
Intervention Type
Device
Intervention Name(s)
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Other Intervention Name(s)
AEMD
Intervention Description
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Primary Outcome Measure Information:
Title
Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment
Description
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.
Time Frame
Baseline to post treatment; typically over 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Himle, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

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