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
  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:

  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 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

Resource links provided by NLM:


Further study details as provided by American University:

Primary Outcome Measures:
  • MGH-HS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    self-report measure of trichotillomania symptom severity


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118637

Locations
United States, District of Columbia
American University
Washington, District of Columbia, United States, 20016-8062
Sponsors and Collaborators
American University
  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: May 23, 2013
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 October 16, 2014