Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

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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

, , 

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

, , 


Verification Date

January 2021