Efficacy of COMB (Comprehensive Behavioral) Model of Trea... | NCT01878110

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

NCT01878110

Sponsor

American University

Status

Completed

Last Update Posted

Apr 15, 2015Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Trichotillomania
Hair-Pulling Disorder

Interventions

COMB

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TLC	Other Grant/Funding Number	Trichotillomania Learning Center

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Not provided

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 15, 2015Estimated

Name	Class
Trichotillomania Learning Center	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
COMB	Experimental		Behavioral: COMB

Name	Type	Description	Arm Group Labels	Other Names
COMB	Behavioral		COMB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Massachusetts General Hospital Hairpulling Scale (MGH-HS)	Improvement in hair pulling symptoms	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University		Washington D.C.	District of Columbia		United States

Condition Browse Module

MeSH Terms

ID	Term
D014256	Trichotillomania

Ancestor Terms

ID	Term
D009771	Obsessive-Compulsive Disorder
D001008	Anxiety Disorders
D001523	Mental Disorders
D007174	Disruptive, Impulse Control, and Conduct Disorders

Browse Leaves

Not provided

Browse Branches

Not provided