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

NCT ID: NCT00455663

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2006-01-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Adaptation Training

Intervention Type: BEHAVIORAL

Environmental supports for all independent living skills

Pharm-Cognitive Adaptation Training

Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.

Group Type: EXPERIMENTAL

Pharm-Cognitive Adaptation Training

Intervention Type: BEHAVIORAL

Environmental supports for medication and appointment adherence

Treatment As Usual

Medication follow up and limited case management provided by local mental health authority

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Medication follow-up and limited case management provided by local community mental health authority

Interventions

Cognitive Adaptation Training

Environmental supports for all independent living skills

Intervention Type: BEHAVIORAL

Pharm-Cognitive Adaptation Training

Environmental supports for medication and appointment adherence

Intervention Type: BEHAVIORAL

Treatment as usual

Medication follow-up and limited case management provided by local community mental health authority

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Dawn Velligan

Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn I. Velligan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Health Science Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

R01MH062850

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 96-BHA

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH062850

Identifier Type: NIH

Identifier Source: org_study_id

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