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NCT01118637 · ClinicalTrials.gov registry record · Phase 2
Stepped Care in the Treatment of Trichotillomania
A Phase 2 study, sponsored by American University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01118637 is a Phase 2 study that has completed, run by American University. The registered enrollment target is 60 participants.
The verdict
NCT01118637, a Phase 2 study, has completed, sponsored by American University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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: 1. To gather preliminary data on the efficacy of web-based self-help, compared to wait list control; 2. 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; 3. 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
Interventions
- BEHAVIORAL StopPulling.com
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01118637
The ClinicalTrials.gov registry entry for NCT01118637 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American University, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which StopPulling.com is the first listed.
NCT01118637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01118637 about?
NCT01118637 is a clinical study titled "Stepped Care in the Treatment of Trichotillomania". 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 c...
What is the current status of trial NCT01118637?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01118637?
The interventions under investigation include: StopPulling.com (BEHAVIORAL).
Who is sponsoring clinical trial NCT01118637?
This trial is sponsored by American University, which has 16 total clinical trials registered on ClinicalTrials.gov.
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