Phase 2
N=20
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Trichotillomania
Bottom Line
View on ClinicalTrials.gov: NCT01654523 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment — 6.695 Units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment |
6.695 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01654523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.