Schizophrenia
Conditions
Keywords
Schizoaffective Disorder, Medication Adherence
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.
Interventions
BEHAVIORALCognitive Adaptation Training
Environmental supports for all independent living skills
BEHAVIORALPharm-Cognitive Adaptation Training
Environmental supports for medication and appointment adherence
OTHERTreatment as usual
Medication follow-up and limited case management provided by local community mental health authority
Sponsors
National Institute of Mental Health (NIMH)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence-pill Count | 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. |
| Positive Symptoms | 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. |
| Social and Occupational Functioning Scale Score | 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. |
| Number of Patients Surviving Without Relapse/Exacerbation | 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 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Pharm-Cognitive Adaptation Training Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up. | 32 |
| Treatment As Usual Medication follow up and limited case management provided by local mental health authority | 29 |
| Total | 95 |
Baseline characteristics
| Characteristic | Cognitive Adaptation Training | Pharm-Cognitive Adaptation Training | Treatment As Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 9.4 | 40 years STANDARD_DEVIATION 11.1 | 39 years STANDARD_DEVIATION 22.1 | 39.0 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 22 Participants | 14 Participants | 18 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 32 | 0 / 29 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 | 0 / 29 |
Outcome results
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.
Time frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pharm-Cognitive Adaptation Training | Medication Adherence-pill Count | 80.8 percentage of medication taken | Standard Error 4.5 |
| Cognitive Adaptation Training | Medication Adherence-pill Count | 81.43 percentage of medication taken | Standard Error 3.7 |
| Treatment as Usual | Medication Adherence-pill Count | 57.3 percentage of medication taken | Standard Error 3.7 |
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
Time frame: 9 months of treatment 6 months follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharm-Cognitive Adaptation Training | Number of Patients Surviving Without Relapse/Exacerbation | 15 participants |
| Cognitive Adaptation Training | Number of Patients Surviving Without Relapse/Exacerbation | 14 participants |
| Treatment as Usual | Number of Patients Surviving Without Relapse/Exacerbation | 4 participants |
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.
Time frame: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pharm-Cognitive Adaptation Training | Positive Symptoms | 2.3 units on a scale | Standard Error 0.15 |
| Cognitive Adaptation Training | Positive Symptoms | 2.5 units on a scale | Standard Error 0.17 |
| Treatment as Usual | Positive Symptoms | 2.3 units on a scale | Standard Error 0.15 |
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.
Time frame: 1 endpoint ls means combining 9 months of treatment and 6 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharm-Cognitive Adaptation Training | Social and Occupational Functioning Scale Score | 50.8 units on a scale | Standard Error 1.1 |
| Cognitive Adaptation Training | Social and Occupational Functioning Scale Score | 45.2 units on a scale | Standard Error 1.3 |
| Treatment as Usual | Social and Occupational Functioning Scale Score | 42.6 units on a scale | Standard Error 1.2 |