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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Other |
| |
| Cognitive Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy | Behavioral | Goal-oriented talk therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Scale | baseline, 6 month, 12 month, 18 month, 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Scale for Assessment of Negative Symptoms | Baseline, 6M, 12M, 18M, 24M | |
| Scale for Assessment of Positive Symptoms | BL, 6M, 12M, 18M, 24M |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron T Beck, MD | University Professor, Department of Psychiatry, University of Pennsylvania | Principal Investigator |
| Paul M Grant, PhD | Assistant Professor, Department of Psychiatry, University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychopathology Resarch Unit, Department of Psychiatry, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15968839 | Background | Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503. | |
| Background | Beck AT, Rector NA, Stolar, NM, & Grant PM. Schizophrenia: Cognitive theory, research, and therapy. New York: Guilford Press | ||
| 21969420 |
| Label | URL |
|---|---|
| Beck Institute for Cognitive Therapy and Research | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D019984 | Quality Indicators, Health Care |
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| Treatment as Usual | Other | Keep getting usual care |
|
|
| Result |
| 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 2011 Oct 3. |
| National Alliance of Research on Schizophrenia and Depression | View source |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |