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Completed

NCT Number: NCT01118637

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

American University

Washington D.C., District of Columbia, 20016-8062, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StopPulling.com

Behavioral

subsidized access to an interactive self-help website for TTM

Primary outcomes

  1. MGH-HS

    Time frame: 10 weeks

    self-report measure of trichotillomania symptom severity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

American University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 7, 2010
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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