Stepped Care in the Treatment of Trichotillomania
Primary Purpose
Trichotillomania
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
StopPulling.com
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring trichotillomania, self-help, web-based, habit reversal, behavior therapy
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- regular internet access
- if taking medications for Trichotillomania, on stable dose for at least 4 weeks
- have trichotillomania (DSM IV criteria except that increasing and decreasing tension with pulling not required)
Exclusion Criteria:
- current suicidality
- current major depression
- current psychosis
- current severe anxiety
- current substance abuse
- current psychotherapy focused on trichotillomania
Sites / Locations
- American University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate
Wait list
Arm Description
Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)
Assigned to wait list for 10 weeks before receiving step 1 treatment.
Outcomes
Primary Outcome Measures
MGH-HS
self-report measure of trichotillomania symptom severity
Secondary Outcome Measures
PITS
interviewer rating of trichotillomania symptom severity
Step 2 completion
% of patients completing step 1 (self-help) who go on to complete step 2
Full Information
NCT ID
NCT01118637
First Posted
May 5, 2010
Last Updated
May 23, 2013
Sponsor
American University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01118637
Brief Title
Stepped Care in the Treatment of Trichotillomania
Official Title
Stepped Care in the Treatment of Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Trichotillomania (TTM), repetitive pulling out of one's own hair to the extent that noticeable hair loss occurs, is a distressing condition interfering substantially with functioning and quality of life. The longterm objective of this research is to determine whether psychological treatment of TTM could be disseminated more effectively by using a stepped care model in which less intensive interventions are tried first, with more intensive interventions used only if initial treatment proves insufficient. This project is a pilot study of the first two steps in a stepped care model of treatment. After baseline assessment, 50 participants with TTM will be randomly assigned to (a) Immediate condition, in which they are offered 10-week self-help treatment via an interactive website (Step 1) or (b) Wait List/Delayed Start condition, a 10-week wait list prior to being offered Step 1. In each condition, at the end of Step 1, participants will be offered 8 weeks of in-person habit reversal training provided by psychology graduate students (Step 2). TTM symptoms will be measured from baseline through a follow-up 3 months after the end of Step 2, as will depression, anxiety, quality of life, functional impairment , treatment utilization, and treatment satisfaction.
The specific aims of the study are:
To gather preliminary data on the efficacy of web-based self-help, compared to wait list control;
To characterize the acceptability of stepped care to patients with TTM by assessing the proportion of enrolled participants who proceed from step 1 to step 2 treatment;
To evaluate the convergent validity of four decision rules for concluding that a patient with TTM has benefited sufficiently from a treatment step: (a) No longer meeting TTM diagnostic criteria; (b) Showing a 25% or greater reduction in total scores on self-report and clinician-rated TTM symptoms; (c) achieving complete abstinence from hair-pulling; and (d) clinically significant response on both self-report and clinician-rated TTM symptom measures
To evaluate the concurrent and predictive validity of criteria for sufficient benefit from a treatment step by relating them to treatment satisfaction, treatment utilization, and scores on a measure of functional impairment from TTM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
trichotillomania, self-help, web-based, habit reversal, behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate
Arm Type
Experimental
Arm Description
Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Assigned to wait list for 10 weeks before receiving step 1 treatment.
Intervention Type
Behavioral
Intervention Name(s)
StopPulling.com
Intervention Description
subsidized access to an interactive self-help website for TTM
Primary Outcome Measure Information:
Title
MGH-HS
Description
self-report measure of trichotillomania symptom severity
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
PITS
Description
interviewer rating of trichotillomania symptom severity
Time Frame
10 weeks
Title
Step 2 completion
Description
% of patients completing step 1 (self-help) who go on to complete step 2
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
regular internet access
if taking medications for Trichotillomania, on stable dose for at least 4 weeks
have trichotillomania (DSM IV criteria except that increasing and decreasing tension with pulling not required)
Exclusion Criteria:
current suicidality
current major depression
current psychosis
current severe anxiety
current substance abuse
current psychotherapy focused on trichotillomania
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016-8062
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stepped Care in the Treatment of Trichotillomania
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