Treating Thought Problems in Patients With Schizophrenia

NCT ID: NCT00051740

Last Updated: 2013-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Adaptation Therapy

Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia

Group Type ACTIVE_COMPARATOR

Cognitive Adaptation Therapy (CAT)

Intervention Type BEHAVIORAL

Minimal Environmental Support

Subjects receive minimal environmental support in schizophrenia treatment

Group Type ACTIVE_COMPARATOR

Minimal Environmental Supports (MES)

Intervention Type BEHAVIORAL

Interventions

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Cognitive Adaptation Therapy (CAT)

Intervention Type BEHAVIORAL

Minimal Environmental Supports (MES)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Dawn Velligan

Clinical Professor Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dawn I. Velligan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DATR A4-GPS

Identifier Type: -

Identifier Source: secondary_id

R01MH061775

Identifier Type: NIH

Identifier Source: org_study_id

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