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.

Study Overview

• Status: Completed
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: StopPulling.com

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016-8062
      • American University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MGH-HS	self-report measure of trichotillomania symptom severity	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PITS	interviewer rating of trichotillomania symptom severity	10 weeks
Step 2 completion	% of patients completing step 1 (self-help) who go on to complete step 2	18 weeks

Collaborators and Investigators

• Sponsor: American University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 23, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: trichotillomania; behavior therapy; self-help; web-based; habit reversal
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania
• Other Study ID Numbers: 1R15MH086852-01A1 (U.S. NIH Grant/Contract)