Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Moderate Depression; Breast Cancer Female; Breast Cancer Stage I; Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; Mild Depression
• Interventions: Other: MBCT

• Registration Number: NCT06336538
• Lead Sponsor: Case Comprehensive Cancer Center

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 American/Black (AA/B) breast cancer survivors (BCS) experience high rates of depression and higher cancer-related mortality than non-Hispanic white BCS.Treating 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 AA/Bs 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 AA/B 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 Oncology's (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 2.5-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 AA/B BCS (i.e. addressing psychological stressors specific to older AA/B BCS and including discussion of culturally relevant topics) or tested a culturally-adapted MBCT-Brief intervention in older AA/B BCS.

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-28
• Study Start: 2025-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• ≥65 years old
• fluency in English
• female
• African American/Black
• diagnosis of Stage I, II or III breast cancer
• at least 3 months past active treatment for cancer (chemotherapy, surgery and/or radiation therapy) with no additional treatment scheduled except endocrine therapy
• mild to moderate symptoms of depression (Patient Health Questionnaire-9(26) scores 4-14)
• willing to be audio and video-recorded
• willing to provide written informed consent.

Exclusion Criteria

• moderately severe or severe depression (PHQ-9 scores ≥15)
• comorbid psychiatric illness or other psychological disorders that would interfere with the ability to participate in or receive benefit from MBCT-Brief, including generalized social anxiety disorder, panic disorder, post-traumatic stress disorder, obsessive-compulsive disorder, drug abuse or dependence, bipolar disorder, borderline personality disorder, and active suicidal ideation.
• changes in antidepressant medication within 6 weeks of intake
• prior history of engaging in formal MBIs including Mindfulness-Based Stress Reduction, MBCT, Acceptance and Commitment Therapy, Dialectical Behavior Therapy
• current daily meditation practice

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy	MBCT	MBCT-Brief includes 8 weekly 1-hour group sessions delivered either via telephone or video teleconferencing. The decision to deliver the intervention either via phone or teleconferencing will be made based on participant preference obtained during the formative focus groups. Telephone delivery of MBCT-Brief only requires a landline, while teleconferencing requires either a smartphone, tablet, or computer with audio and video functionality. During the MBCT-Brief intervention the instructor will lead in-session practice of medication and cognitive therapy exercises, guided inquiry, and assign and review at-home practice exercises. All sessions will be audio-recorded. Participants will be encouraged to practice daily meditation in between group sessions for 20 minutes, 6 days per week. Participants will complete practice logs to document daily meditation practice.

Primary Outcome Measures

Name	Time	Method
Mean participant attendance rate	8 weeks	Feasibility rate is measured by calculating the mean percent of intervention sessions attended by the participants

Secondary Outcome Measures

Name	Time	Method
Acceptability rate using CSQ(Client Satisfaction Questionnaire-8)	At 8 weeks	This is an 8-item self-report measure where response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. A mean score of ≥25 on the CSQ is considered "high satisfaction"

Trial Locations

Locations (1)

Cleveland Clinic Department of Wellness and Preventive Medicine; 🇺🇸 Cleveland, Ohio, United States