Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336538
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
Abbreviated MBCT for Depression in Older African AmericanBlack Breast Cancer Survivors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Community Engagement in the Development of an Abbreviated Mindfulness-Based Cognitive Therapy Intervention for Depression in Older African AmericanBlack Breast Cancer Survivors Community Minds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression
Detailed Description:
Older African AmericanBlack AAB breast cancer survivors BCS experience high rates of depression and higher cancer-related mortality than non-Hispanic white BCSTreating depression in BCS is critical since it is associated with poor health outcomes in part due to its detrimental effect on health behaviors and high rate of relapse Depression is an independent prognostic factor in BCS and associated with a 25 increased risk of cancer recurrence 30 increased risk of all-cause mortality and 29 increased risk of cancer-specific mortality Clinical trials have found that treating depression in a cohort of women with metastatic breast cancer leads to an increase in survival However recent studies have found that depression is under-treated in participants with cancer and despite increases in prescribing practices for antidepressants rates of depression are steadily rising Unfortunately older adults and AABs are both under-represented in clinical research and experience health disparities that limit access to evidence-based culturally-relevant depression interventions In addition current standard treatment of depression with anti-depressant medications is associated with poor adherence side effects unpredictable responsiveness and have drug interactions with antineoplastic and endocrine therapy medications Little is known regarding novel non-pharmacological treatments for depression in these populations and reducing barriers to clinical trial participation is essential to develop new evidence-based approaches to depression for older AA BCS Thus it is critical to development non-pharmacological approaches for depression for older AAB BCS and reduce barriers to clinical trial participation
Mindfulness-Based Cognitive Therapy MBCT is a group-based psychological intervention for depression that combines mindfulness training with cognitive therapy MBCT reduces depressive symptoms in BCS and the American Society of Clinical Oncologys ASCO guidelines recommend mindfulness-based interventions MBIs such as MBCT for depression during and after cancer treatment However MBCT has significant time and logistical burden that limits clinical trial participation and clinical implementation due to its 8 weekly 25-hour in-person sessions To address these barriers investigators developed an abbreviated MBCT protocol MBCT-Brief that is remotely delivered and 8 weekly 1-hour sessions However no studies have adapted MBCT-Brief for the specific needs of older AAB BCS ie addressing psychological stressors specific to older AAB BCS and including discussion of culturally relevant topics or tested a culturally-adapted MBCT-Brief intervention in older AAB BCS
Mindfulness-Based Cognitive Therapy MBCT is a group-based psychological intervention for depression that combines mindfulness training with cognitive therapy MBCT reduces depressive symptoms in BCS and the American Society of Clinical Oncologys ASCO guidelines recommend mindfulness-based interventions MBIs such as MBCT for depression during and after cancer treatment However MBCT has significant time and logistical burden that limits clinical trial participation and clinical implementation due to its 8 weekly 25-hour in-person sessions To address these barriers investigators developed an abbreviated MBCT protocol MBCT-Brief that is remotely delivered and 8 weekly 1-hour sessions However no studies have adapted MBCT-Brief for the specific needs of older AAB BCS ie addressing psychological stressors specific to older AAB BCS and including discussion of culturally relevant topics or tested a culturally-adapted MBCT-Brief intervention in older AAB BCS
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