Treating Thought Problems in Patients With Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

January 15, 2003

Last Updated Date

November 29, 2005

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00051740 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treating Thought Problems in Patients With Schizophrenia

Official Title ^ICMJE

Compensating for Cognitive Deficits in Schizophrenia

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00051740

Responsible Party

Study ID Numbers ^ICMJE

R01 MH61775, DATR A4-GPS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dawn I. Velligan, Ph.D.

University of Texas

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP