Stepped Care in the Treatment of Trichotillomania

Trichotillomania Clinical Trial

Official title:

Stepped Care in the Treatment of Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118637
• Other study ID #: 1R15MH086852-01A1
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: May 23, 2013
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: American University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Behavioral:
• StopPulling.com
subsidized access to an interactive self-help website for TTM

Locations

Country	Name	City	State
United States	American University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MGH-HS	self-report measure of trichotillomania symptom severity	10 weeks	No
Secondary	PITS	interviewer rating of trichotillomania symptom severity	10 weeks	No
Secondary	Step 2 completion	% of patients completing step 1 (self-help) who go on to complete step 2	18 weeks	No

External Links

•   related information