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CompletedNCT01118637Updated May 27, 2013

Stepped Care in the Treatment of Trichotillomania

A Phase 2 interventional study of StopPulling.com in Trichotillomania, sponsored by American University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-27.

Sponsored by American University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Trichotillomania

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Keywords

  • trichotillomania
  • self-help
  • web-based
  • habit reversal
  • behavior therapy
03

In context

Trichotillomania

44 studies on the registry are indexed under Trichotillomania; 7 are open to participants now.

This study's enrollment of 60 is above the median of 38 across 42 interventional studies indexed under Trichotillomania.

Browse Trichotillomania studies →

Lead sponsor

American University is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • current suicidality
  • current major depression
  • current psychosis
  • current severe anxiety
  • current substance abuse
  • current psychotherapy focused on trichotillomania
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Immediate

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

    Behavioral: StopPulling.com

  • No intervention
    Wait list

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

Interventions

  • BehavioralStopPulling.com

    subsidized access to an interactive self-help website for TTM

06

What researchers measure

Primary outcomes

  1. MGH-HS

    self-report measure of trichotillomania symptom severity

    Time frame: 10 weeks

Secondary outcomes

  1. PITS

    interviewer rating of trichotillomania symptom severity

    Time frame: 10 weeks

  2. Step 2 completion

    % of patients completing step 1 (self-help) who go on to complete step 2

    Time frame: 18 weeks

07

Study locations

1 site
  • American University
    Washington, District of Columbia 20016-8062, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01118637
Lead sponsor
American University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
David A. F. Haaga (Professor of Psychology, American University) — Principal investigator
First posted
May 7, 2010
Start date
Aug 2010
Primary completion
Nov 2012
Completion
Nov 2012
Last update
May 27, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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