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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
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, social cognition, cognition, treatment, outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 21, 2007
Last Updated
April 28, 2023
Sponsor
VA Connecticut Healthcare System
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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

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Efficacy of Social Cognition Training in Schizophrenia

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