Cognitive - Behavioral Therapy | NCT00018629

Studies
Cognitive - Behavioral Therapy

NCT00018629

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Jan 7, 2009Estimated

Enrollment

76Actual

Phase

Phase 2

Conditions

Schizoaffective Disorder
Schizophrenia

Interventions

Not provided

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

Status Module

Record Verification Date

Sep 2008

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

May 2000

Primary Completion Date

Apr 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Jul 3, 2001

First Submission Date that Met QC Criteria

Jul 4, 2001

First Posted Date

Jul 5, 2001Estimated

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

Jan 5, 2009

Last Update Posted Date

Jan 7, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia.

Detailed Description

This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Name	Type	Description	Arm Group Labels	Other Names
	Other

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 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

Name	Affiliation	Role
Eric L. Granholm, PhD	VA San Diego Healthcare System, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA San Diego Healthcare System, San Diego		San Diego	California	92161	United States

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided