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Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania

Primary Purpose

Trichotillomania, Hair-Pulling Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COMB
Sponsored by
American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring Trichotillomania, Hair pulling, Behavior therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)

Exclusion Criteria:

  • Current suicidality or severe depression
  • Current psychosis
  • Current alcohol or substance abuse
  • Concurrent psychotherapy for TTM
  • Psychotropic meds (for any disorder) that have not been stable for >4 weeks

Sites / Locations

  • American University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COMB

Arm Description

Outcomes

Primary Outcome Measures

Massachusetts General Hospital Hairpulling Scale (MGH-HS)
Improvement in hair pulling symptoms

Secondary Outcome Measures

Full Information

First Posted
June 10, 2013
Last Updated
April 14, 2015
Sponsor
American University
Collaborators
Trichotillomania Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT01878110
Brief Title
Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania
Official Title
Treatment Development Study of the COMB Model of Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
Trichotillomania Learning Center

4. Oversight

5. Study Description

Brief Summary
This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania, Hair-Pulling Disorder
Keywords
Trichotillomania, Hair pulling, Behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COMB
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
COMB
Primary Outcome Measure Information:
Title
Massachusetts General Hospital Hairpulling Scale (MGH-HS)
Description
Improvement in hair pulling symptoms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM) Exclusion Criteria: Current suicidality or severe depression Current psychosis Current alcohol or substance abuse Concurrent psychotherapy for TTM Psychotropic meds (for any disorder) that have not been stable for >4 weeks
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania

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