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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH062850 | U.S. NIH Grant/Contract | View source | |
| DAHBR 96-BHA | Other Identifier | UTHSCSA |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Adaptation Training | Experimental | 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. |
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| Pharm-Cognitive Adaptation Training | Experimental | Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. |
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| Treatment As Usual | Active Comparator | Medication follow up and limited case management provided by local mental health authority |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Adaptation Training | Behavioral | Environmental supports for all independent living skills |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 final score combined for endpoint for 9 months of treatment and 6 months 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. | 1 final endpoint least sq mean combining 9 months of treatment 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. | 1 endpoint ls means combining 9 months of treatment and 6 months 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 | 9 months of treatment 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn I. Velligan, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | San Antonio | Texas | 78229-3900 | United States |
Of the 99 recruited at hospital Discharge:11 rehospitalized,9 not located,8 withdrew consent,4 incarcerated,3 unable to complete assessments,2 aggressive behavior,2 medication,1 deceased Of 57 outpatient recruits;4 withdrew consent,1 unable to complete assessments,1 medication, 1 unsafe,1 aggression, 1 substance abuse, 1 deceased, 1 moved
Subjects were outpatients recruited in 2 streams. Ninety-nine were recruited at the time of discharge from an inpatient psychiatric facility and followed for 3 months after discharge prior to baseline assessments and randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Pharm-Cognitive Adaptation Training |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pharm-Cognitive Adaptation Training | Behavioral | Environmental supports for medication and appointment adherence |
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| Treatment as usual | Other | Medication follow-up and limited case management provided by local community mental health authority |
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Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. |
| FG002 | Treatment As Usual | Medication follow up and limited case management provided by local mental health authority |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Pharm-Cognitive Adaptation Training | Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. |
| BG002 | Treatment As Usual | Medication follow up and limited case management provided by local mental health authority |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | percentage of medication taken | 1 final score combined for endpoint for 9 months of treatment and 6 months follow up |
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| Primary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up |
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| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 1 endpoint ls means combining 9 months of treatment and 6 months follow up |
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| Primary | 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 | Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only. | Posted | Number | participants | 9 months of treatment 6 months follow up |
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study duration 15 mos.
Patient reported events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 34 | 0 | 34 | ||
| EG001 | Pharm-Cognitive Adaptation Training | Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. | 0 | 32 | 0 | 32 | ||
| EG002 | Treatment As Usual | Medication follow up and limited case management provided by local mental health authority | 0 | 29 | 0 | 29 |
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Subjects were ill for a long-period of time
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn I. Velligan | UTHSCSA | 210-567-5508 | velligand@uthscsa.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Male |
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| Participants |
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