Trial Outcomes & Findings for Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania (NCT NCT01654523)

NCT ID: NCT01654523

Last Updated: 2016-07-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline to post treatment; typically over 9 weeks
• Results posted on: 2016-07-22

Participant Flow

33 people were consented and interviewed for participation; 20 met study criteria and agreed to continued with the project.

Participant milestones

Measure	Awareness Enhancement and Monitoring Device Open trial with no randomization Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Awareness Enhancement and Monitoring Device Open trial with no randomization Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Baseline characteristics by cohort

Measure	Treatment Arm n=20 Participants Open trial with no randomization Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Age, Continuous	32.93 years STANDARD_DEVIATION 9.635 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
NIMH Trichotillomania Severity and Impairment Scale	13.00 units on a scale STANDARD_DEVIATION 4.04 • n=5 Participants
Massachusetts General Hospital Hair Pulling Scale	16.12 units on a scale STANDARD_DEVIATION 4.07 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Awareness Enhancement and Monitoring Device n=19 Participants Open trial with no randomization Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment	6.695 Units on a scale Standard Deviation 5.505

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Himle - Professor

University of Michigan

Phone: 7343303258

Email: himlej@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place