Treating Thought Problems in Patients With Schizophrenia | NCT00051740

Studies
Treating Thought Problems in Patients With Schizophrenia

NCT00051740

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Completed

Last Update Posted

Apr 9, 2013Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Cognitive Adaptation Therapy (CAT)
Minimal Environmental Supports (MES)

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
DATR A4-GPS

Status Module

Record Verification Date

Apr 2013

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

Feb 2002

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 15, 2003

First Submission Date that Met QC Criteria

Jan 16, 2003

First Posted Date

Jan 17, 2003Estimated

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 5, 2013

Last Update Posted Date

Apr 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dawn Velligan, Clinical Professor Department of Psychiatry, The University of Texas Health Science Center at San AntonioPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center at San AntonioOTHER

Collaborators

Not provided

Description Module

Brief Summary

This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia.

Detailed Description

Many schizophrenia patients have serious difficulties that affect their quality of life. Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or environmental supports, is tailored to each individual and is based on executive functioning levels and other factors.

Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits will be slowly reduced to once a month. For the remaining 12 months of treatment, patients receive CAT only once a month.

Participants assigned to the MES group receive a generic set of supplies and equipment (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each month, the supplies are replenished as necessary during the patient's scheduled clinic visit.

In all groups, assessments of adaptive function and quality of life occur at study start and at 3, 6, 9, 18, and 24 months.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Adaptation Therapy	Active Comparator	Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia	Behavioral: Cognitive Adaptation Therapy (CAT)
Minimal Environmental Support	Active Comparator	Subjects receive minimal environmental support in schizophrenia treatment	Behavioral: Minimal Environmental Supports (MES)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Adaptation Therapy (CAT)	Behavioral		Cognitive Adaptation Therapy
Minimal Environmental Supports (MES)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary	compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.	up to 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Treatment with an atypical antipsychotic medication
Stable living environment
Able to read, understand, and complete rating scales and neuropsychological testing
Willing to participate in psychosocial treatments for schizophrenia that may involve home visits

Exclusion Criteria:

History of significant head trauma, seizure disorder, or mental retardation
Alcohol or drug abuse that could interfere with participation in the study
Treatment by an ACT team
History of violence in the past year
Score > 80 on the SOFAS
Hospitalized in the past year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dawn I. Velligan, Ph.D.	The University of Texas Health Science Center at San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center at San Antonio		San Antonio	Texas	78229	United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided