Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03972020
Status:
UNKNOWN
Last Update Posted:
2020-07-02
First Post:
2019-02-11
Brief Title:
Mindful-life Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Mindful-life a Randomized Clinical Trial to Evaluate the Efficacy of a Mindfulness Based Intervention as Compared to Cognitive Behavioral Therapy for Depressive Symptoms and Quality of Life in Patients With Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
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:
Breast cancer is the most common cancer pathology among women worldwide and represents a complex psychological challenge for those affected Diagnosis and subsequent treatments can have a significant impact not only on the physical well-being of people but also on their psychological well-being Tumor-related distress is described as an unpleasant emotional multifactorial experience of a psychological social and or spiritual nature that can interfere with the ability to effectively cope with cancer physical symptoms and treatment from the National Comprehensive Cancer NetworkStudies have shown that from one third to half of breast cancer patients can experience psychological distress The psychological distress understood as symptoms of anxiety depression and stress is related to a lower quality of life a lower compliance related to a lower efficacy of the treatments a higher mortality and a higher risk of suicide so much so that this discomfort it is recognized as the sixth vital sign in cancer treatment Both the diagnosis of cancer and the treatments related to the disease can lead to the alternation of depressive phases and in some cases even to the presence of major depression it is estimated that the levels of depression reach thresholds that oscillate between 5 and 25 between women suffering from breast cancer
In reference to what are the interventions aimed at reducing depressive symptomatology in patients with breast cancer in this study we refer in particular to 2 treatments of which several studies attest to their effectiveness interventions based on Mindfulness MBI and interventions based on cognitive behavioral therapy CBT
Cognitive-behavioral therapy CBT is an empirically supported treatment for depression Numerous studies have shown that CBT is both effective in treating acute depression and preventing subsequent relapses and relapses after the end of active treatment
MBI-based interventions have been widely disseminated both at the clinical and research level as short cost-effective interventions
Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms sleep fatigue disease adaptation and stress reduction with coping and well-being improved in patients with chronic illnesses including also the oncological pathologies In particular a meta-analysis of studies conducted on women with breast cancer confirmed the effectiveness of MBI in reducing symptoms of anxiety depression and stress suggesting the importance of these treatments in improving the mental health of these women In addition studies have shown that the improvements achieved are stable even at long-term follow-up
In reference to what are the interventions aimed at reducing depressive symptomatology in patients with breast cancer in this study we refer in particular to 2 treatments of which several studies attest to their effectiveness interventions based on Mindfulness MBI and interventions based on cognitive behavioral therapy CBT
Cognitive-behavioral therapy CBT is an empirically supported treatment for depression Numerous studies have shown that CBT is both effective in treating acute depression and preventing subsequent relapses and relapses after the end of active treatment
MBI-based interventions have been widely disseminated both at the clinical and research level as short cost-effective interventions
Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms sleep fatigue disease adaptation and stress reduction with coping and well-being improved in patients with chronic illnesses including also the oncological pathologies In particular a meta-analysis of studies conducted on women with breast cancer confirmed the effectiveness of MBI in reducing symptoms of anxiety depression and stress suggesting the importance of these treatments in improving the mental health of these women In addition studies have shown that the improvements achieved are stable even at long-term follow-up
Detailed Description:
None
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