NCT01175642

Brief Summary

This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for early_phase_1 schizophrenia

Timeline
Completed

Started Jul 2007

Typical duration for early_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

Study Start

First participant enrolled

July 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 17, 2016

Status Verified

August 1, 2010

Enrollment Period

3.1 years

First QC Date

August 3, 2010

Last Update Submit

November 16, 2016

Conditions

Keywords

SchizophreniaPsychosisSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • neurocognition

    12 weeks

Secondary Outcomes (5)

  • functional competence

    12 weeks

  • neurocognition

    24 weeks

  • neurocognition

    36 weeks

  • functional competence

    24 weeks

  • functional competence

    36 weeks

Study Arms (3)

Cognitive remediation

EXPERIMENTAL

Cognitive remediation

Behavioral: Cognitive Remediation

Functional Adaptive Skills Training

ACTIVE COMPARATOR

Functional and social skills group treatment

Behavioral: FAST

Combined Treatment

ACTIVE COMPARATOR

Combined cognitive remediation and functional adaptive skills training

Behavioral: Cognitive RemediationBehavioral: FAST

Interventions

Computer-based, therapist-lead cognitive remediation

Cognitive remediationCombined Treatment
FASTBEHAVIORAL

Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills

Combined TreatmentFunctional Adaptive Skills Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Enrolled in outpatient mental health care
  • Reading level of 6th grade or higher
  • English speaking

You may not qualify if:

  • Medical conditions known to affect cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christopher R Bowie, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

July 1, 2007

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 17, 2016

Record last verified: 2010-08

Data Sharing

IPD Sharing
Will not share

Locations