Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Adaptation Training
Pharm-Cognitive Adaptation Training
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizoaffective Disorder, Medication Adherence
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
Sites / Locations
- University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Cognitive Adaptation Training
Pharm-Cognitive Adaptation Training
Treatment As Usual
Arm Description
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.
Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
Medication follow up and limited case management provided by local mental health authority
Outcomes
Primary Outcome Measures
Medication Adherence-pill Count
% 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
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.
Social and Occupational Functioning Scale Score
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.
Number of Patients Surviving Without Relapse/Exacerbation
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00455663
First Posted
April 2, 2007
Last Updated
May 29, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00455663
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizoaffective Disorder, Medication Adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Adaptation Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Pharm-Cognitive Adaptation Training
Arm Type
Experimental
Arm Description
Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Medication follow up and limited case management provided by local mental health authority
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Adaptation Training
Intervention Description
Environmental supports for all independent living skills
Intervention Type
Behavioral
Intervention Name(s)
Pharm-Cognitive Adaptation Training
Intervention Description
Environmental supports for medication and appointment adherence
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Medication follow-up and limited case management provided by local community mental health authority
Primary Outcome Measure Information:
Title
Medication Adherence-pill Count
Description
% 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.
Time Frame
1 final score combined for endpoint for 9 months of treatment and 6 months follow up
Title
Positive Symptoms
Description
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.
Time Frame
1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
Title
Social and Occupational Functioning Scale Score
Description
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.
Time Frame
1 endpoint ls means combining 9 months of treatment and 6 months follow up
Title
Number of Patients Surviving Without Relapse/Exacerbation
Description
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
Time Frame
9 months of treatment 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn I. Velligan, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
12. IPD Sharing Statement
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Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
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