Stepped Care in the Treatment of Trichotillomania

NCT01118637 | Completed Phase 2 DMC

• 1 other identifier: 1R15MH086852-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.To gather preliminary data on the efficacy of web-based self-help, compared to wait list control;
2. 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. 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. 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.

Conditions

Trichotillomania

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MGH-HS

  self-report measure of trichotillomania symptom severity

  10 weeks

Secondary Outcomes (2)

• PITS

  10 weeks

• Step 2 completion

  18 weeks

Study Arms (2)

Immediate

EXPERIMENTAL

Assigned immediately after baseline assessment to receive step 1 treatment (web-based self-help)

Behavioral: StopPulling.com

Wait list

NO INTERVENTION

Assigned to wait list for 10 weeks before receiving step 1 treatment.

Interventions

StopPulling.com BEHAVIORAL

subsidized access to an interactive self-help website for TTM

Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• current suicidality
• current major depression
• current psychosis
• current severe anxiety
• current substance abuse
• current psychotherapy focused on trichotillomania

Sponsors & Collaborators

• American University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016-8062, United States

Location

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (1)