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Stepped Care in the 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. Identifier: NCT01118637
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : May 27, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David A. F. Haaga, American University

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:

  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 and clinician-rated TTM symptom measures
  4. 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: Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Immediate
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.

Primary Outcome Measures :
  1. MGH-HS [ Time Frame: 10 weeks ]
    self-report measure of trichotillomania symptom severity

Secondary Outcome Measures :
  1. PITS [ Time Frame: 10 weeks ]
    interviewer rating of trichotillomania symptom severity

  2. Step 2 completion [ Time Frame: 18 weeks ]
    % of patients completing step 1 (self-help) who go on to complete step 2

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01118637

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United States, District of Columbia
American University
Washington, District of Columbia, United States, 20016-8062
Sponsors and Collaborators
American University
National Institute of Mental Health (NIMH)

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Responsible Party: David A. F. Haaga, Professor of Psychology, American University Identifier: NCT01118637     History of Changes
Other Study ID Numbers: 1R15MH086852-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by David A. F. Haaga, American University:
habit reversal
behavior therapy

Additional relevant MeSH terms:
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Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders