Clinical trial NCT00455663: Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
Official title: Medication Adherence and Outcomes in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizoaffective Disorder
Medication Adherence
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-04-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Medication Adherence-pill Count
timeFrame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up
measure: Positive Symptoms
timeFrame: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
measure: Social and Occupational Functioning Scale Score
timeFrame: 1 endpoint ls means combining 9 months of treatment and 6 months follow up
measure: Number of Patients Surviving Without Relapse/Exacerbation
timeFrame: 9 months of treatment 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Dawn I. Velligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: