Treating Thought Problems in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dawn Velligan, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00051740
First received: January 15, 2003
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Compensating for Cognitive Deficits in Schizophrenia

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Primary [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.


Estimated Enrollment: 120
Study Start Date: February 2002
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Adaptation Therapy
Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia
Behavioral: Cognitive Adaptation Therapy (CAT)
Active Comparator: Minimal Environmental Support
Subjects receive minimal environmental support in schizophrenia treatment
Behavioral: Minimal Environmental Supports (MES)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051740

Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Dawn I. Velligan, Ph.D. The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Dawn Velligan, Clinical Professor Department of Psychiatry, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00051740     History of Changes
Other Study ID Numbers: R01 MH61775, DATR A4-GPS
Study First Received: January 15, 2003
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 11, 2014