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Stepped Care in the Treatment of Trichotillomania

Stepped Care in the Treatment of Trichotillomania

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01118637
Enrollment
60
Registered
2010-05-07
Start date
2010-08-31
Completion date
2012-11-30
Last updated
2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trichotillomania

Keywords

trichotillomania, self-help, web-based, habit reversal, behavior therapy

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.

Interventions

BEHAVIORALStopPulling.com

subsidized access to an interactive self-help website for TTM

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
American University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MGH-HS10 weeksself-report measure of trichotillomania symptom severity

Secondary

MeasureTime frameDescription
PITS10 weeksinterviewer rating of trichotillomania symptom severity
Step 2 completion18 weeks% of patients completing step 1 (self-help) who go on to complete step 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026