Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

• 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: University of Michigan
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Joseph Himle, University of Michigan

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.

Condition or disease	Intervention/treatment	Phase
Trichotillomania	Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
• Study Start Date: January 2005
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Treatment arm; Open trial with no randomization	Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania; Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania; Other Name: AEMD

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Joseph A Himle, PhD; University of Michigan

More Information

• Responsible Party: Joseph Himle, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01654523
• Other Study ID Numbers: HUM00050426; 2R42MH077362-02 ( U.S. NIH Grant/Contract )
• First Posted: July 31, 2012
• Results First Posted: July 22, 2016
• Last Update Posted: July 22, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Joseph Himle, University of Michigan:

Trichotillomania

Additional relevant MeSH terms:

Trichotillomania; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders