Cognitive Therapy for Negative Symptoms and Functioning

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00350883
First received: July 7, 2006
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Behavioral: Cognitive Therapy
Other: Treatment as Usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Therapy for Negative Symptoms and Functioning

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Global Assessment Scale [ Time Frame: baseline, 6 month, 12 month, 18 month, 24 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scale for Assessment of Negative Symptoms [ Time Frame: Baseline, 6M, 12M, 18M, 24M ] [ Designated as safety issue: No ]
  • Scale for Assessment of Positive Symptoms [ Time Frame: BL, 6M, 12M, 18M, 24M ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: July 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment as Usual Other: Treatment as Usual
Keep getting usual care
Other Names:
  • Standard care
  • Enriched care
Experimental: Cognitive Therapy Behavioral: Cognitive Therapy
Goal-oriented talk therapy
Other Name: Cognitive Behavioral Therapy

Detailed Description:

This is a clinical trial to evaluate the efficacy of adjunctive cognitive behavioral therapy for negative symptoms and functioning in chronic outpatients diagnosed with schizophrenia or schizoaffective disorder. After a baseline assessment to ensure eligibility, seventy-five consenting patients will be randomly assigned to receive a year of cognitive therapy (CT) or to a treatment as usual (TAU) control condition. Measures of symptomatology (positive, negative and affective), functioning, neurocognition and negativistic beliefs will be administered to all participants during five formal assessment sessions to occur at 6-month intervals over the course of a two-year period. The first assessment session (Baseline) will occur shortly after (i.e., within a week, though typically on the same day) informed consent is given. If the participant qualifies for the study and is consents to randomization, assessments identical to the baseline in content will occur 6, 12, 18 and 24 months later. All evaluators will be blind to participant treatment condition at the time of assessment.

The cognitive behavioral treatment will, in a collaborative and problem solving manner, target inaccurate or overly pessimistic expectations and thoughts about social and non-social performance. This psychosocial intervention will also target beliefs and attitudes that are related to positive symptoms which, in turn, exacerbate negative symptoms and impair functioning. We hypothesize that patients in the CT condition will have lower negative symptom levels and elevated functioning as compared to the TAU patients at the post-treatment assessment. Additionally, we expect that CT-treated patients will continue to improve over the follow-up period and, thereby, to continue to manifest lowered negative symptoms and elevated levels of functioning relative to TAU patients.

While research over the past 10 years has demonstrated the efficacy of CT as an adjunct intervention in the treatment of schizophrenia, negative symptoms have not been targeted directly, nor has an emphasis been placed upon improving functional outcomes. Given that negative symptoms and functioning are particularly refractory in this population, there is a need for treatment innovation. In this vein, our previous research (Grant & Beck, 2006) established that defeatist attitudes regarding social and non-social performance are important mediators in the causal chains that link neurocognitive performance, negative symptoms, and functional outcomes in schizophrenia. The current trial, thus, aims to move therapy for schizophrenia forward by improving long-term outcomes for some of the most impaired individuals in psychiatric service.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350883

Locations
United States, Pennsylvania
Psychopathology Resarch Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Aaron T Beck, MD University Professor, Department of Psychiatry, University of Pennsylvania
Study Director: Paul M Grant, PhD Assistant Professor, Department of Psychiatry, University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Aaron T Beck, Universtiy of Pennsylvania
ClinicalTrials.gov Identifier: NCT00350883     History of Changes
Other Study ID Numbers: 804915
Study First Received: July 7, 2006
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Cognitive Therapy
Negative Symptoms
Functional Outcomes
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014