Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455663
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2007-04-02
Brief Title:
Cognitive Adaptive Training for Improving Medication Adherence Symptoms and Function in People With Schizophrenia
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Medication Adherence and Outcomes in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CATs 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 participants 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
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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 96-BHA | OTHER | UTHSCSA | httpsreporternihgovquickSearchR01MH062850 |
| R01MH062850 | NIH | None | None |