Stepped Care in the Treatment of Trichotillomania

NCT ID: NCT01118637

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-11-30

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.

Conditions

Trichotillomania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Immediate

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

Group Type: EXPERIMENTAL

StopPulling.com

Intervention Type: BEHAVIORAL

subsidized access to an interactive self-help website for TTM

Wait list

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

StopPulling.com

subsidized access to an interactive self-help website for TTM

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

American University

OTHER

Sponsor Role: lead

Responsible Party

David A. F. Haaga

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

1R15MH086852-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link