NCT00051740

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable schizophrenia

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

February 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

6.7 years

First QC Date

January 15, 2003

Last Update Submit

April 5, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Primary

    compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.

    up to 24 months

Study Arms (2)

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

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Dawn I. Velligan, Ph.D.

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor Department of Psychiatry

Study Record Dates

First Submitted

January 15, 2003

First Posted

January 17, 2003

Study Start

February 1, 2002

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

US(1)