| City: |
|
Philadelphia |
|
State:
|
|
PA |
| Zip Code: |
|
19104 |
| Conditions: |
|
Schizophrenia - Schizoaffective Disorder |
| 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).
|
| Study summary: |
|
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. |
| 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 |
|
|
|
| Study is available at: |
|
Psychopathology Resarch Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, PA 19104
United States
Primary Contact:
Paul M Grant, Dr.
Email: pgrant@mail.med.upenn.edu
Phone: 215-898-1825
Secondary Contact:
Paul M Grant, PhD
Email: pgrant@mail.med.upenn.edu
Phone: (215) 898-1825 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|