Trichotillomania
Conditions
Keywords
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.
Interventions
DEVICEAwareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment | 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. |
Countries
United States
Participant flow
Recruitment details
33 people were consented and interviewed for participation; 20 met study criteria and agreed to continued with the project.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Open trial with no randomization
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 32.93 years STANDARD_DEVIATION 9.635 |
| Massachusetts General Hospital Hair Pulling Scale | 16.12 units on a scale STANDARD_DEVIATION 4.07 |
| NIMH Trichotillomania Severity and Impairment Scale | 13.00 units on a scale STANDARD_DEVIATION 4.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline to post treatment; typically over 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Awareness Enhancement and Monitoring Device | Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment | 6.695 Units on a scale | Standard Deviation 5.505 |
p-value: <0.0595% CI: [4.041, 9.348]Paired t-test