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
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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
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Verification Date
May 2013