Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03067311
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2017-02-16
Brief Title:
Targeting Stress Reactivity in Schizophrenia Integrated Coping Awareness Therapy
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Targeting Stress Reactivity in Schizophrenia Integrated Coping Awareness Therapy I-CAT
Status:
COMPLETED
Status Verified Date:
2020-05
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:
I-CAT
Brief Summary:
To test the feasibility of a clinical trial implementing I-CAT a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping as well as a range of possible proximal eg autonomic endocrine immune indices of stress reactivity symptom severity and distal measures function relapse quality of life for 40 people with first episode psychosis in the context of a small randomized controlled trial
Detailed Description:
Schizophrenia is one of the most devastating disorders that often results in a lack of functional recovery Current treatments focused on remediating symptoms have shown only small successes in a return to functioning despite evidence of a dysregulated stress response There is a fundamental gap in understanding the impact of allostatic overload in persons with schizophrenia that the investigators theorize is associated with deficits in functioning and with an increased vulnerability and relapse risk The long-term goal is to test an intervention aimed at improving stress reactivity The objective in this application is to develop and test the feasibility of a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping The central hypothesis is that an intervention that improves stress reactivity as measured proximally by endocrine immune and autonomic indices will result in improved adaptive capacity better role functioning reduced risk of relapse and decreased likelihood of disability for people in the early stages of schizophrenia
The rationale for the proposed research is that stress reactivity may be a modifiable risk factor underlying functional deficits in schizophrenia The intervention integrates two treatment approaches The first is based on research showing that mindfulness meditation practice is associated with alterations in the neural processing of stressful events and targets adaptive responses to stress The second focuses on providing a buffer against stress by using the self-generation of adaptive emotions with a positive psychology intervention which is potentially associated with building protective social resources These complimentary interventions provide a comprehensive synergistic approach for this population that could lead to more adaptive coping responses and create a buffer against stress
The rationale for the proposed research is that stress reactivity may be a modifiable risk factor underlying functional deficits in schizophrenia The intervention integrates two treatment approaches The first is based on research showing that mindfulness meditation practice is associated with alterations in the neural processing of stressful events and targets adaptive responses to stress The second focuses on providing a buffer against stress by using the self-generation of adaptive emotions with a positive psychology intervention which is potentially associated with building protective social resources These complimentary interventions provide a comprehensive synergistic approach for this population that could lead to more adaptive coping responses and create a buffer against stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R33MH100250-03 | NIH | None | httpsreporternihgovquickSearch4R33MH100250-03 |