Stepped Care in the Treatment of Trichotillomania
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|ClinicalTrials.gov Identifier: NCT01118637|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Trichotillomania||Behavioral: StopPulling.com||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Stepped Care in the Treatment of Trichotillomania|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)
subsidized access to an interactive self-help website for TTM
No Intervention: Wait list
Assigned to wait list for 10 weeks before receiving step 1 treatment.
- MGH-HS [ Time Frame: 10 weeks ]self-report measure of trichotillomania symptom severity
- PITS [ Time Frame: 10 weeks ]interviewer rating of trichotillomania symptom severity
- Step 2 completion [ Time Frame: 18 weeks ]% of patients completing step 1 (self-help) who go on to complete step 2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118637
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20016-8062|