Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
Medication Adherence and Outcomes in Schizophrenia
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229-3900
- University of Texas Health Science Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Environmental supports for all independent living skills
|
|
Experimental: Pharm-Cognitive Adaptation Training
Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
|
Environmental supports for medication and appointment adherence
|
|
Active Comparator: Treatment As Usual
Medication follow up and limited case management provided by local mental health authority
|
Medication follow-up and limited case management provided by local community mental health authority
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence-pill Count
Time Frame: 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.
|
1 final score combined for endpoint for 9 months of treatment and 6 months follow up
|
|
Positive Symptoms
Time Frame: 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.
|
1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
|
|
Social and Occupational Functioning Scale Score
Time Frame: 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.
|
1 endpoint ls means combining 9 months of treatment and 6 months follow up
|
|
Number of Patients Surviving Without Relapse/Exacerbation
Time Frame: 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
|
9 months of treatment 6 months follow up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dawn I. Velligan, PhD, University of Texas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH062850 (U.S. NIH Grant/Contract)
- DAHBR 96-BHA (UTHSCSA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.