Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.
Behavioral: Cognitive Adaptation Training
Behavioral: Pharm-Cognitive Adaptation Training
|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|
- Medication adherence
- Schizophrenia symptoms
- Social and occupational functioning
- Relapse (all measured every 3 months throughout the study)
- Additonal measures of medication adherence (measured every 3 months throughout the study)
|Study Start Date:||November 2000|
|Estimated Study Completion Date:||January 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455663
|United States, Texas|
|University of Texas Health Science Center|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Dawn I. Velligan, PhD||University of Texas|