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Social Cognitive Training for Psychosis: Treatment Development

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01579422
First received: April 10, 2012
Last updated: January 11, 2016
Last verified: January 2016
  Purpose

The primary aim of this proposal is to develop, refine, manualize and assess the feasibility and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for individuals with psychosis. The intervention will focus on helping individuals interpret social situations, specifically the intentions and feelings of others.

Study methods include preliminary treatment and manual development based on series of uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly developed intervention.


Condition Intervention Phase
Schizophrenia Psychosis Behavioral: social cognitive training Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Social Cognitive Training for Psychosis: Phase I Treatment Development

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • social cognition [ Time Frame: change from baseline to approximately 6 weeks ]
    AIHQ Eyes Task Hinting Task IPSAQ


Enrollment: 77
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: social cognitive training Behavioral: social cognitive training
social cognitive training, 8-10 sessions

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or other psychotic disorder
  • Age between 18 and 55
  • Psychiatrically stable
  • Clinician agrees to individual's participation in study
  • English as primary language

Exclusion Criteria:

  • current (past 30 days) symptoms of alcohol abuse/dependence
  • developmental disability
  • severe auditory/visual impairment or known neurological disorder
  • participant has a legal conservator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579422

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01579422     History of Changes
Other Study ID Numbers: 1008007225
1R34MH090109 ( U.S. NIH Grant/Contract )
Study First Received: April 10, 2012
Last Updated: January 11, 2016

Keywords provided by Yale University:
schizophrenia
treatment
social cognition

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on August 17, 2017