Stepped Care in the Treatment of Trichotillomania

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David A. F. Haaga, American University
ClinicalTrials.gov Identifier:
NCT01118637
First received: May 5, 2010
Last updated: May 23, 2013
Last verified: May 2013

May 5, 2010
May 23, 2013
August 2010
November 2012   (final data collection date for primary outcome measure)
MGH-HS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
self-report measure of trichotillomania symptom severity
Same as current
Complete list of historical versions of study NCT01118637 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Stepped Care in the Treatment of Trichotillomania
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Trichotillomania
Behavioral: StopPulling.com
subsidized access to an interactive self-help website for TTM
  • Experimental: Immediate
    Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)
    Intervention: Behavioral: StopPulling.com
  • No Intervention: Wait list
    Assigned to wait list for 10 weeks before receiving step 1 treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118637
1R15MH086852-01A1
Yes
David A. F. Haaga, American University
American University
National Institute of Mental Health (NIMH)
Not Provided
American University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP