- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587561
Efficacy of Social Cognition Training in Schizophrenia
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.
Objectives:
This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.
Research Design and Methodology:
Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Connecticut Mental Health Center
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of schizophrenia or schizoaffective disorder
- Age between 18 and 65
- minimum of 30 days since discharge from last hospitalization
- minimum of 30 days since last change in psychiatric medications
- no housing changes in the past 30 days
Exclusion Criteria:
- current diagnosis of alcohol or substance abuse/dependence
- history of brain trauma or neurological disease
- mental retardation or developmental disability
- auditory or visual impairment that would interfere with study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 Social Cognition Interaction Training
Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training
|
manualized group therapy
|
|
Other: 2 Wait List Control
Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group
|
wait-list control for 6 months, followed by the experimental group therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Cognitive Measures
Time Frame: 6 months - baseline
|
change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement
|
6 months - baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Basic Cognitive Measures
Time Frame: 6 months - baseline
|
change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score
|
6 months - baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joanna Fiszdon, Ph.D., VA Connecticut Heathcare System and Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JMF0005
- D4628W
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