Cognitive Therapy for Negative Symptoms and Functioning
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

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).
    

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.
    

Intervention name(s): Cognitive Therapy; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Goal-oriented talk therapy; Keep getting usual care
Other intervention name(s): Cognitive Behavioral Therapy; Standard care; Enriched care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Therapy; Negative Symptoms; Functional Outcomes; Schizophrenia; Schizoaffective Disorder