Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01654523
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph Himle, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Trichotillomania
Intervention Device: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
Enrollment 33
Recruitment Details 33 people were consented and interviewed for participation; 20 met study criteria and agreed to continued with the project.
Pre-assignment Details  
Arm/Group Title Awareness Enhancement and Monitoring Device
Hide Arm/Group Description

Open trial with no randomization

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

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Open trial with no randomization

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
32.93  (9.635)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.0%
White
19
  95.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
NIMH Trichotillomania Severity and Impairment Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
13.00  (4.04)
[1]
Measure Description: The NIMH Trichotillomania Severity and Impairment Scale was used to measure baseline severity and associated functional impairment of trichotillomania. This clinician-rated instrument yields a severity score that measures average time spent pulling, time spent pulling on the previous day, resistance to pulling urges, distress associated with pulling, and interference related to trichotillomania. Each item yields a score from 0 – 5 with 5 indicating the highest severity, resulting in a total of 25 possible points.
Massachusetts General Hospital Hair Pulling Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
16.12  (4.07)
[1]
Measure Description: The Massachusetts General Hospital Hair Pulling Scale was used to measure the severity and associated functional impairment related to trichotillomania. This self-report instrument yields a total severity score. It contains seven items. Each item on this scale yields a score from 0 – 4 with 4 indicating the highest severity. The lowest possible total score is zero and the highest possible score, indicating highest severity of trichotillomania is 28.
1.Primary Outcome
Title Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Awareness Enhancement and Monitoring Device
Hide Arm/Group Description:

Open trial with no randomization

Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.695  (5.505)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Awareness Enhancement and Monitoring Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change in the single arm trial
Estimated Value 6.695
Confidence Interval (2-Sided) 95%
4.041 to 9.348
Parameter Dispersion
Type: Standard Deviation
Value: 5.505
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Open trial with no randomization

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

All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph Himle - Professor
Organization: University of Michigan
Phone: 7343303258
Responsible Party: Joseph Himle, University of Michigan
ClinicalTrials.gov Identifier: NCT01654523     History of Changes
Other Study ID Numbers: HUM00050426
2R42MH077362-02 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2012
First Posted: July 31, 2012
Results First Submitted: January 28, 2016
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016