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NCT01579422 Clinical Trial

Social Cognitive Training for Psychosis: Treatment Development

Schizophrenia Clinical Trial

Official title:
Social Cognitive Training for Psychosis: Phase I Treatment Development

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01579422
Other study ID # 1008007225
Secondary ID 1R34MH090109
Status Completed
Phase Phase 1
First received April 10, 2012
Last updated January 11, 2016
Start date May 2012
Est. completion date December 2015

Study information
Verified date January 2016
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date December 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• social cognitive training
social cognitive training, 8-10 sessions

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary social cognition AIHQ Eyes Task Hinting Task IPSAQ change from baseline to approximately 6 weeks No
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