Stepped Care in the Treatment of Trichotillomania
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Trichotillomania |
Behavioral: StopPulling.com |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stepped Care in the Treatment of Trichotillomania |
- MGH-HS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]self-report measure of trichotillomania symptom severity
- PITS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]interviewer rating of trichotillomania symptom severity
- Step 2 completion [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]% of patients completing step 1 (self-help) who go on to complete step 2
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate
Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)
|
Behavioral: StopPulling.com
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | David A. F. Haaga, Professor of Psychology, American University |
| ClinicalTrials.gov Identifier: | NCT01118637 History of Changes |
| Other Study ID Numbers: | 1R15MH086852-01A1 |
| Study First Received: | May 5, 2010 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by American University:
|
trichotillomania self-help web-based habit reversal behavior therapy |
Additional relevant MeSH terms:
|
Trichotillomania Impulse Control Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013