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

July 7, 2006
May 2, 2012
July 2006
November 2011   (final data collection date for primary outcome measure)
Global Assessment Scale [ Time Frame: baseline, 6 month, 12 month, 18 month, 24 month ] [ Designated as safety issue: No ]
  • Global Assessment Scale
  • Scale for the Assessment of Negative Symptoms
  • Strauss-Carpenter Levels of Function
  • Quality of Life Scale, Abbreviated
Complete list of historical versions of study NCT00350883 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Dysfunctional Attitude Scale
  • Revised Social Anhedonia Scale
  • Neurocognitive Battery
  • Beck Depression Inventory
  • Beck Anxiety Inventory
Not Provided
Not Provided
 
Cognitive Therapy for Negative Symptoms and Functioning
Cognitive Therapy for Negative Symptoms and Functioning

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Behavioral: Cognitive Therapy
    Goal-oriented talk therapy
    Other Name: Cognitive Behavioral Therapy
  • Other: Treatment as Usual
    Keep getting usual care
    Other Names:
    • Standard care
    • Enriched care
  • Treatment as Usual
    Intervention: Other: Treatment as Usual
  • Experimental: Cognitive Therapy
    Intervention: Behavioral: Cognitive Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00350883
804915
Yes
Aaron T Beck, Universtiy of Pennsylvania
University of Pennsylvania
National Alliance for Research on Schizophrenia and Depression
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
University of Pennsylvania
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP