VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073, United States
NCT Number: NCT00470106
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
West Los Angeles, California, 90073, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Computer exercises in attention, memory, and speed of processing.
Group training on emotion perception, social perception, and understanding others' mental states.
A combination of the two groups listed above.
Skills training in how to identify symptoms of illness and medication side effects.
Time frame: 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.
Time frame: 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.
VA Office of Research and Development
Fed
Acronym: IBASC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01945333
Mental Disorders, Psychotic Disorders
Brooklyn, New York, United States
View Trial DetailsNCT00001486
Behavior, Behavioral Symptoms
Bethesda, Maryland, United States
View Trial DetailsNCT00942981
Mental Disorders, Psychotic Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT06007105
Acute and Transient Psychotic Disorder, Bipolar Type I Disorder With Psychotic Symptoms
Blantyre, Southern Region, Malawi
View Trial Details