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

Not Applicable

Completed

Conditions: Schizophrenia

Interventions: Behavioral: Cognitive Adaptation Training
Behavioral: Pharm-Cognitive Adaptation Training
Other: Treatment as usual

Registration Number: NCT00455663

Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Adaptation Training	Cognitive Adaptation Training	In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
Pharm-Cognitive Adaptation Training	Pharm-Cognitive Adaptation Training	Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
Treatment As Usual	Treatment as usual	Medication follow up and limited case management provided by local mental health authority

Primary Outcome Measures

Name	Time	Method
Social and Occupational Functioning Scale Score	1 endpoint ls means combining 9 months of treatment and 6 months follow up	Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Medication Adherence-pill Count	1 final score combined for endpoint for 9 months of treatment and 6 months follow up	% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Positive Symptoms	1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up	Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.
Number of Patients Surviving Without Relapse/Exacerbation	9 months of treatment 6 months follow up	A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision