Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Social Cognitive Training for Psychosis: Treatment Development

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joanna Fiszdon, Yale University
ClinicalTrials.gov Identifier:
NCT01579422
First received: April 10, 2012
Last updated: January 21, 2015
Last verified: January 2015

April 10, 2012
January 21, 2015
May 2012
May 2015   (final data collection date for primary outcome measure)
social cognition [ Time Frame: change from baseline to approximately 6 weeks ] [ Designated as safety issue: No ]
AIHQ Eyes Task Hinting Task IPSAQ
Same as current
Complete list of historical versions of study NCT01579422 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Social Cognitive Training for Psychosis: Treatment Development
Social Cognitive Training for Psychosis: Phase I Treatment Development

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Psychosis
Behavioral: social cognitive training
social cognitive training, 8-10 sessions
Experimental: social cognitive training
Intervention: Behavioral: social cognitive training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579422
A08405, 1R34MH090109
No
Joanna Fiszdon, Yale University
Yale University
National Institute of Mental Health (NIMH)
Not Provided
Yale University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP