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

January 15, 2003
April 5, 2013
February 2002
October 2008   (final data collection date for primary outcome measure)
Primary [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment.
Not Provided
Complete list of historical versions of study NCT00051740 on ClinicalTrials.gov Archive Site
Not Provided
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Treating Thought Problems in Patients With Schizophrenia
Compensating for Cognitive Deficits in Schizophrenia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Cognitive Adaptation Therapy (CAT)
  • Behavioral: Minimal Environmental Supports (MES)
  • Active Comparator: Cognitive Adaptation Therapy
    Subjects receive Cognitive adaptation therapy as part of treatment for schizophrenia
    Intervention: Behavioral: Cognitive Adaptation Therapy (CAT)
  • Active Comparator: Minimal Environmental Support
    Subjects receive minimal environmental support in schizophrenia treatment
    Intervention: Behavioral: Minimal Environmental Supports (MES)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051740
R01 MH61775, DATR A4-GPS
Not Provided
Dawn Velligan, The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Not Provided
Principal Investigator: Dawn I. Velligan, Ph.D. University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
April 2013

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