Social Cognitive Training for Psychosis: Treatment Develo... | NCT01579422

Studies
Social Cognitive Training for Psychosis: Treatment Development

NCT01579422

Sponsor

Yale University

Status

Completed

Last Update Posted

Jan 12, 2016Estimated

Enrollment

77Actual

Phase

Phase 1

Conditions

Schizophrenia
Psychosis

Interventions

social cognitive training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R34MH090109	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Aug 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Apr 16, 2012

First Posted Date

Apr 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
social cognitive training	Experimental		Behavioral: social cognitive training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
social cognitive training	Behavioral	social cognitive training, 8-10 sessions	social cognitive training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
social cognition	AIHQ Eyes Task Hinting Task IPSAQ	change from baseline to approximately 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Healthcare System		West Haven	Connecticut	06516	United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided