NCT01878110

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

June 10, 2013

Last Update Submit

April 14, 2015

Conditions

TrichotillomaniaHair-Pulling Disorder

Keywords

TrichotillomaniaHair pullingBehavior therapy

Outcome Measures

Primary Outcomes (1)

  • Massachusetts General Hospital Hairpulling Scale (MGH-HS)

    Improvement in hair pulling symptoms

    12 weeks

Study Arms (1)

COMB

EXPERIMENTAL
Behavioral: COMB

Interventions

COMBBEHAVIORAL
COMB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University

Washington D.C., District of Columbia, United States

Location

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 14, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)