Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00455663
First received: April 2, 2007
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.


Condition Intervention
Schizophrenia
Behavioral: Cognitive Adaptation Training
Behavioral: Pharm-Cognitive Adaptation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Medication Adherence and Outcomes in Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Medication adherence
  • Schizophrenia symptoms
  • Social and occupational functioning
  • Relapse (all measured every 3 months throughout the study)

Secondary Outcome Measures:
  • Additonal measures of medication adherence (measured every 3 months throughout the study)

Estimated Enrollment: 90
Study Start Date: November 2000
Estimated Study Completion Date: January 2006
Detailed Description:

Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients’ capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT’s support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.

After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant’s home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • If entering the study as an inpatient, hospitalization was recent
  • Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended
  • Assumes primary responsibility for taking medication
  • Currently living in a stable environment

Exclusion Criteria:

  • History of significant head trauma, seizure disorder, or mental retardation
  • History of alcohol or drug abuse or dependence within 1 month prior to study entry
  • History of violence within 6 months prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455663

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
Investigators
Principal Investigator: Dawn I. Velligan, PhD University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00455663     History of Changes
Other Study ID Numbers: R01 MH62850, DAHBR 96-BHA
Study First Received: April 2, 2007
Last Updated: April 3, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizoaffective Disorder
Medication Adherence

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

ClinicalTrials.gov processed this record on April 17, 2014