Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350883
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2006-07-07
Brief Title:
Cognitive Therapy for Negative Symptoms and Functioning
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Cognitive Therapy for Negative Symptoms and Functioning
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None