Brief Title
Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Official Title
Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Brief Summary
This study will be the first randomized controlled trial of Comprehensive Behavior
Modification (ComB) as a treatment of trichotillomania (TTM). ComB treatment (12 weekly
sessions, following a manual developed in an earlier treatment development project) will be
compared to Minimal Attention Control among adults (N = 42) with TTM.
Detailed Description
Treatment based on the ComB model has been influential in the field of body-focused
repetitive behaviors (BFRB's), but there is limited empirical research on its efficacy. Our
first project (Falkenstein et al., 2016) developed a 12-session manual for ComB and a method
for evaluating therapist adherence to the model that can be used reliably and provided
encouraging (uncontrolled) data on the effects of ComB through 3-month follow-up.
The proposed project extends the earlier work in two main ways: (a) using random assignment
to ComB vs. comparison condition to test whether ComB works better than the passage of time +
demand characteristics of being in a TTM study alone; and (b) gathering initial evidence on
how ComB works.
Treatment will be conducted at two sites -- Washington, DC (American University and the
Behavior Therapy Center of Greater Washington) and Chicago (University of Chicago).
Participants in the Minimal Attention Control condition will receive ComB therapy after the
post-treatment [week 12] assessment is conducted. Uncontrolled follow-up data will be
collected through 3 (MAC condition) or 6 (immediate ComB condition) months after the end of
ComB treatment.
Study Type
Interventional
Primary Outcome
Change in Massachusetts General Hospital Hairpulling Scale
Secondary Outcome
Alopecia rating
Condition
Trichotillomania
Intervention
Comprehensive Behavior Modification
Study Arms / Comparison Groups
immediate ComB
Description: 12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
36
Start Date
May 10, 2018
Completion Date
April 30, 2020
Primary Completion Date
April 30, 2020
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- diagnosed with Trichotillomania
- medication type and dosage [if any] stable for at least 3 months
Exclusion Criteria:
- active suicidality
--probable bipolar disorder
- probable psychosis
- other pressing clinical problem requiring immediate treatment
- current psychotherapy and unable/unwilling to discontinue
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03486041
Organization ID
ComB controlled trial
Responsible Party
Principal Investigator
Study Sponsor
American University
Collaborators
University of Chicago
Study Sponsor
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Verification Date
January 2021