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Efficacy of Social Cognition Training in Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00587561
First received: December 21, 2007
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Behavioral: Social Cognition Interaction Training
Behavioral: WLC
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Social Cognition Training in Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Social cognitive measures [ Time Frame: intake, 6 months, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • basic cognitive measures [ Time Frame: intake, 6 months, 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training
 Behavioral: Social Cognition Interaction Training
manualized group therapy
2 WLC
Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group
 Behavioral: WLC
wait-list control for 6 months, followed by the experimental group therapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587561

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06510
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Joanna Fiszdon, Ph.D. VA Connecticut Heathcare System and Yale University
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00587561     History of Changes
Other Study ID Numbers: JMF0005, D4628W
Study First Received: December 21, 2007
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board
United States: Veterans Health Administration
United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
schizophrenia
social cognition
cognition
treatment
outcome

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013