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

Trichotillomania Clinical Trial

Official title:

Treatment Development Study of the COMB Model of Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878110
• Other study ID #: TLC COMB Pilot Study
• Secondary ID: TLC
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: April 14, 2015
• Start date: January 2013

Study information

• Verified date: April 2015
• Source: American University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hair-Pulling Disorder
• Trichotillomania

Intervention

Behavioral:
• COMB

Locations

Country	Name	City	State
United States	American University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American University	Trichotillomania Learning Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Massachusetts General Hospital Hairpulling Scale (MGH-HS)	Improvement in hair pulling symptoms	12 weeks	No