Stepped Care in the Treatment of Trichotillomania

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Brief Title

Stepped Care in the Treatment of Trichotillomania

Official Title

Stepped Care in the Treatment of Trichotillomania

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

MGH-HS

Secondary Outcome

 PITS

Condition

Trichotillomania

Intervention

StopPulling.com

Study Arms / Comparison Groups

 Immediate
Description:  Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

60

Start Date

August 2010

Completion Date

November 2012

Primary Completion Date

November 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01118637

Organization ID

1R15MH086852-01A1


Responsible Party

Principal Investigator

Study Sponsor

American University

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

, , 


Verification Date

May 2013