Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Trichotillomania Clinical Trial

Official title:

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654523
• Other study ID #: HUM00050426
• Secondary ID: 2R42MH077362-02
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2012
• Last updated: July 24, 2015
• Start date: January 2005
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Device:
• Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Awareness Enhancement and Monitoring Device (AEMD)	Participant use of the AEMD will be electronically monitored via the AEMD's internal date/time tracking capabilities.	1/1/2005 - 1/1/2013 (8 years)	No