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Social Cognitive Training for Psychosis: Treatment Development

Primary Purpose

Schizophrenia, Psychosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

social cognitive training

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, treatment, social cognition

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

social cognitive training

Arm Description

Outcomes

Primary Outcome Measures

social cognition

AIHQ Eyes Task Hinting Task IPSAQ

Secondary Outcome Measures

Full Information

NCT ID

NCT01579422

First Posted

April 10, 2012

Last Updated

January 11, 2016

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01579422

Brief Title

Social Cognitive Training for Psychosis: Treatment Development

Official Title

Social Cognitive Training for Psychosis: Phase I Treatment Development

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Psychosis

Keywords

schizophrenia, treatment, social cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

social cognitive training

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

social cognitive training

Intervention Description

social cognitive training, 8-10 sessions

Primary Outcome Measure Information:

Title

social cognition

Description

AIHQ Eyes Task Hinting Task IPSAQ

Time Frame

change from baseline to approximately 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

VA Connecticut Healthcare System

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Social Cognitive Training for Psychosis: Treatment Development

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