Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
July 22, 2016
CompletedJuly 22, 2016
June 1, 2016
9.4 years
May 10, 2012
January 28, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to post treatment; typically over 9 weeks
Study Arms (1)
Treatment arm
OTHEROpen trial with no randomization
Interventions
Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph Himle - Professor
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Himle, PhD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 10, 2012
First Posted
July 31, 2012
Study Start
January 1, 2005
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 22, 2016
Results First Posted
July 22, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share