Cognitive Therapy for Negative Symptoms and Functioning

Schizophrenia Clinical Trial

Official title:

Cognitive Therapy for Negative Symptoms and Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350883
• Other study ID #: 804915
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2006
• Last updated: May 2, 2012
• Start date: July 2006
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive Therapy
Goal-oriented talk therapy

Other:
• Treatment as Usual
Keep getting usual care

Locations

Country	Name	City	State
United States	Psychopathology Resarch Unit, Department of Psychiatry, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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 — View Citation

Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment Scale		baseline, 6 month, 12 month, 18 month, 24 month	No
Secondary	Scale for Assessment of Negative Symptoms		Baseline, 6M, 12M, 18M, 24M	No
Secondary	Scale for Assessment of Positive Symptoms		BL, 6M, 12M, 18M, 24M	No

External Links

•   Beck Institute for Cognitive Therapy and Research
•   National Alliance of Research on Schizophrenia and Depression