Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Cognition, Remediation, Schizophrenia, Social Cognition
Brief summary
Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder.
Detailed description
Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder. We plan to recruit 72 patients over the 2 years of the study from the outpatient clinics at the VA Greater Los Angeles Healthcare System (VAGLAHS). They will receive baseline assessment that includes measures of social cognition, basic cognition, electrophysiology, functional capacity, clinical symptoms, community status, and demographics / clinical history. Follow up assessments will be administered at the mid-point of training (at 6 weeks) and end of training (at 12 weeks). Each follow up assessment will include measures of basic cognition, social cognition, electrophysiology, functional capacity, and clinical symptoms. The tester administering the assessments will be blind to treatment group. Subjects will be randomly assigned to one of four groups: 1) social cognitive training, 2) basic cognitive remediation, 3) a combined social cognitive and basic cognitive intervention, or 4) social skills training. All groups will meet in one-hour sessions held twice a week over the course of 12 weeks in small groups of 3-6. The Social Cognition Intervention (SCI) is a new 24-session, manualized intervention program specifically designed to improve emotion perception, social context processing, and theory of mind / attributional bias in veterans with schizophrenia and schizoaffective disorder. The Basic Cognitive Intervention (BCI) will involve computer-assisted training exercises. Each participant will work individually on a notebook computer. The combined intervention will cover the same content areas as the social cognitive and basic cognitive interventions, but will not go into as much detail as the separate intervention programs. The control condition will be facilitated discussion of current events. Treatment will be administered in a group format with three to six patients and a training coach.
Interventions
BEHAVIORALCognitive remediation
Computer exercises in attention, memory, and speed of processing.
BEHAVIORALSocial Cognitive skills training
Group training on emotion perception, social perception, and understanding others' mental states.
BEHAVIORALhybrid intervention
A combination of the two groups listed above.
BEHAVIORALskills training
Skills training in how to identify symptoms of illness and medication side effects.
Sponsors
VA Office of Research and Development
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
* All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified according to Diagnosis and Statistical Manual-IV criteria. * In addition, the subjects will meet the following criteria: * Between 18 and 60 years of age * Estimated premorbid intelligence quotient \> 70 (based on reading ability) * Understand spoken English sufficiently to comprehend testing procedures * Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 6 weeks prior to enrollment, and none anticipated for the 3 months of participation)
Exclusion criteria
* No clinically significant neurological disease as determined by medical history * No history of serious head injury (e.g., loss of consciousness longer than 1 hour) * No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data * No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing * The patients psychotic experiences can be explained solely by the use of drugs or alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Test Scores for Facial Emotion Identification. | Assessments for end point (12 weeks). | This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | Assessments at endpoint (12 weeks). | This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from outpatient clinics at VA Greater Los Angeles Health care system and local mental health facilities. All patients met Diagnostic and Statistical Manual-IV criteria for schizophrenia, schizoaffective disorder, delusional disorder, or psychosis not otherwise specified (not secondary to substance use disorder)
Pre-assignment details
This is not a drug study so there is no wash out or run in. Participants were excluded if they did not meet diagnostic criteria.
Participants by arm
| Arm | Count |
|---|---|
| Social Cognition Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states. | 16 |
| Cognitive Remediation Cognitive remediation: Computer exercises in attention, memory, and speed of processing. | 19 |
| Hybrid Group Half of the sessions were cognitive remediation and half were social cognitive training. | 14 |
| Control - Social Skills Training This group was a control for the amount of time in sessions. There was no social cognitive training. | 19 |
| Total | 68 |
Baseline characteristics
| Characteristic | Total | Control - Social Skills Training | Hybrid Group | Cognitive Remediation | Social Cognition |
|---|---|---|---|---|---|
| Affect perception | 39.8 number of correct answers STANDARD_DEVIATION 7 | 43.4 number of correct answers STANDARD_DEVIATION 3.7 | 38.6 number of correct answers STANDARD_DEVIATION 8.3 | 40.6 number of correct answers STANDARD_DEVIATION 8.4 | 37.1 number of correct answers STANDARD_DEVIATION 6.1 |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 8.6 | 45.1 years STANDARD_DEVIATION 11.2 | 50.4 years STANDARD_DEVIATION 10.1 | 46.6 years STANDARD_DEVIATION 7.4 | 51.0 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 68 participants | 19 participants | 14 participants | 19 participants | 16 participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 60 Participants | 15 Participants | 13 Participants | 17 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 24 | 1 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 1 / 24 | 2 / 21 | 3 / 21 |
Outcome results
Primary
Mean Test Scores for Facial Emotion Identification.
This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.
Time frame: Assessments for end point (12 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Cognitive Skills Training | Mean Test Scores for Facial Emotion Identification. | 45.5 number of correct answers | Standard Deviation 8.2 |
| Cognitive Remediation | Mean Test Scores for Facial Emotion Identification. | 41.1 number of correct answers | Standard Deviation 12.1 |
| Hybrid Intervention | Mean Test Scores for Facial Emotion Identification. | 43.8 number of correct answers | Standard Deviation 6.7 |
| Skills Training | Mean Test Scores for Facial Emotion Identification. | 45.1 number of correct answers | Standard Deviation 5 |
p-value: <0.001mixed model
Secondary
Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).
This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.
Time frame: Assessments at endpoint (12 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Cognitive Skills Training | Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 3.43 number correct | Standard Deviation 0.78 |
| Cognitive Remediation | Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 3.57 number correct | Standard Deviation 0.74 |
| Hybrid Intervention | Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 3.35 number correct | Standard Deviation 1.11 |
| Skills Training | Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 3.19 number correct | Standard Deviation 0.86 |
p-value: <0.1mixed model