search
Back to results

Treating Thought Problems in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Adaptation Therapy (CAT)
Minimal Environmental Supports (MES)
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Adaptation Therapy

Minimal Environmental Support

Arm Description

Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia

Subjects receive minimal environmental support in schizophrenia treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2003
Last Updated
April 5, 2013
Sponsor
The University of Texas Health Science Center at San Antonio
search

1. Study Identification

Unique Protocol Identification Number
NCT00051740
Brief Title
Treating Thought Problems in Patients With Schizophrenia
Official Title
Compensating for Cognitive Deficits in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Adaptation Therapy
Arm Type
Active Comparator
Arm Description
Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia
Arm Title
Minimal Environmental Support
Arm Type
Active Comparator
Arm Description
Subjects receive minimal environmental support in schizophrenia treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Adaptation Therapy (CAT)
Intervention Type
Behavioral
Intervention Name(s)
Minimal Environmental Supports (MES)
Primary Outcome Measure Information:
Title
Primary
Description
compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn I. Velligan, Ph.D.
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treating Thought Problems in Patients With Schizophrenia

We'll reach out to this number within 24 hrs