NCT00350883

Brief Summary

This clinical trial tests the effectiveness of cognitive therapy (CT) to improve outcomes in outpatients diagnosed with schizophrenia or schizoaffective disorder who manifest prominent negative symptoms. It is hypothesized that patients receiving cognitive therapy will manifest lower negative symptom levels and improved engagement in constructive activity relative to patients who receive treatment-as-usual. Further, it is predicted that these differences between CT and TAU will be larger when patients are assessed 6 and 12 months after the end of treatment (18 and 24 months after study entry).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2 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, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

5.3 years

First QC Date

July 7, 2006

Last Update Submit

May 2, 2012

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Cognitive TherapyNegative SymptomsFunctional OutcomesSchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Global Assessment Scale

    baseline, 6 month, 12 month, 18 month, 24 month

Secondary Outcomes (2)

  • Scale for Assessment of Negative Symptoms

    Baseline, 6M, 12M, 18M, 24M

  • Scale for Assessment of Positive Symptoms

    BL, 6M, 12M, 18M, 24M

Study Arms (2)

Treatment as Usual

OTHER
Other: Treatment as Usual

Cognitive Therapy

EXPERIMENTAL
Behavioral: Cognitive Therapy

Interventions

Cognitive TherapyBEHAVIORAL

Goal-oriented talk therapy

Also known as: Cognitive Behavioral Therapy
Cognitive Therapy
Treatment as UsualOTHER

Keep getting usual care

Also known as: Standard care, Enriched care
Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • Outpatient diagnosed with schizophrenia or schizoaffective disorder
  • Prominent negative symptoms (i.e., two global subscales rated "moderate" or higher on the Scale for the Assessment of Negative Symptoms
  • Proficiency in English
  • Able to give informed consent

You may not qualify if:

  • Neurologic disease or damage
  • Systematic medical illnesses that may compromise neurocognitive functioning (e.g., insulin dependent diabetes, heart disease)
  • History of head injury or documented loss of consciousness
  • Physical handicaps that would interfere with assessment procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychopathology Resarch Unit, Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503.

    PMID: 15968839BACKGROUND

  • Beck AT, Rector NA, Stolar, NM, & Grant PM. Schizophrenia: Cognitive theory, research, and therapy. New York: Guilford Press

    BACKGROUND

  • Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3.

    PMID: 21969420RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Behavioral TherapyTherapeuticsStandard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Aaron T Beck, MD

    University Professor, Department of Psychiatry, University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Paul M Grant, PhD

    Assistant Professor, Department of Psychiatry, University of Pennsylvania

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 3, 2012

Record last verified: 2012-05

Locations

US(1)