NCT00587561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 3, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5.9 years

First QC Date

December 21, 2007

Results QC Date

May 29, 2024

Last Update Submit

September 15, 2025

Conditions

Schizophrenia

Keywords

schizophreniasocial cognitioncognitiontreatmentoutcome

Outcome Measures

Primary Outcomes (1)

  • Social Cognitive Measures

    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 Outcomes (1)

  • Basic Cognitive Measures

    6 months - baseline

Study Arms (2)

1 Social Cognition Interaction Training

EXPERIMENTAL

Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training

Behavioral: Social Cognition Interaction Training

2 Wait List Control

OTHER

Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group

Behavioral: WLC

Interventions

Social Cognition Interaction TrainingBEHAVIORAL

manualized group therapy

1 Social Cognition Interaction Training
WLCBEHAVIORAL

wait-list control for 6 months, followed by the experimental group therapy

2 Wait List Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Connecticut Mental Health Center

New Haven, Connecticut, 06510, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • Fiszdon JM, Dixon HD, Davidson CA, Roberts DL, Penn DL, Bell MD. Efficacy of social cognition and interaction training in outpatients with schizophrenia spectrum disorders: randomized controlled trial. Front Psychiatry. 2023 Aug 4;14:1217735. doi: 10.3389/fpsyt.2023.1217735. eCollection 2023.

    PMID: 37599886RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Dr. Joanna Fiszdon
Organization
VA Connecticut Healthcare System
joanna.fiszdon@va.gov
2039325711

Study Officials

  • Joanna Fiszdon, Ph.D.

    VA Connecticut Heathcare System and Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2023

Last Updated

October 3, 2025

Results First Posted

October 3, 2025

Record last verified: 2025-09

Locations

US(2)