Efficacy of Social Cognition Training in Schizophrenia
Primary Purpose
Schizophrenia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Cognition Interaction Training
WLC
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, social cognition, cognition, treatment, outcome
Eligibility Criteria
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
Sites / Locations
- Connecticut Mental Health Center
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1 Social Cognition Interaction Training
2 Wait List Control
Arm Description
Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training
Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group
Outcomes
Primary Outcome Measures
Social cognitive measures
Secondary Outcome Measures
basic cognitive measures
Full Information
NCT ID
NCT00587561
First Posted
December 21, 2007
Last Updated
April 28, 2023
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00587561
Brief Title
Efficacy of Social Cognition Training in Schizophrenia
Official Title
Efficacy of Social Cognition Training in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, social cognition, cognition, treatment, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Social Cognition Interaction Training
Arm Type
Experimental
Arm Description
Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training
Arm Title
2 Wait List Control
Arm Type
Other
Arm Description
Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition Interaction Training
Intervention Description
manualized group therapy
Intervention Type
Behavioral
Intervention Name(s)
WLC
Intervention Description
wait-list control for 6 months, followed by the experimental group therapy
Primary Outcome Measure Information:
Title
Social cognitive measures
Time Frame
intake, 6 months
Secondary Outcome Measure Information:
Title
basic cognitive measures
Time Frame
intake, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Fiszdon, Ph.D.
Organizational Affiliation
VA Connecticut Heathcare System and Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Social Cognition Training in Schizophrenia
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