NCT01579422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started May 2012

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

April 10, 2012

Last Update Submit

January 11, 2016

Conditions

SchizophreniaPsychosis

Keywords

schizophreniatreatmentsocial cognition

Outcome Measures

Primary Outcomes (1)

  • social cognition

    AIHQ Eyes Task Hinting Task IPSAQ

    change from baseline to approximately 6 weeks

Study Arms (1)

social cognitive training

EXPERIMENTAL
Behavioral: social cognitive training

Interventions

social cognitive trainingBEHAVIORAL

social cognitive training, 8-10 sessions

social cognitive training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • current (past 30 days) symptoms of alcohol abuse/dependence
  • developmental disability
  • severe auditory/visual impairment or known neurological disorder
  • participant has a legal conservator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 18, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)