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

NCT06336538 | Active Not Recruiting DMC

• 1 other identifier: CASE1124
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression.

Conditions

Breast Cancer; Breast Cancer Female; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Mild Depression; Moderate Depression

Keywords

Black African Americans

Outcome Measures

Primary Outcomes (1)

• Mean participant attendance rate

  Feasibility rate is measured by calculating the mean percent of intervention sessions attended by the participants

  8 weeks

Secondary Outcomes (1)

• Acceptability rate using CSQ(Client Satisfaction Questionnaire-8)

  At 8 weeks

Other Outcomes (4)

• Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores

  Baseline, 8 weeks

• Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores

  Baseline, 8 weeks

• Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores

  Baseline, 8 weeks

Study Arms (1)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

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.

Other: MBCT

Interventions

MBCT OTHER

Mindfulness-Based Cognitive Therapy (MBCT) is a group-based psychological intervention for depression that combines mindfulness training with cognitive therapy.

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Department of Wellness and Preventive Medicine

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacob Hill, ND

  Cleveland Clinic Department of Wellness and Preventive Medicine, Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator will first conduct focus groups with older (≥65 years old) African American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms. They will collect participant perspectives on barriers and facilitators to participation in MBI clinical trials, as well as how to adapt this intervention, called Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm clinical trial that incorporates the results of the qualitative data analysis to establish feasibility and acceptability of MBCT-Brief.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: March 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Access Criteria: Interested individuals who request access to study data will need to contact the study Co-PI, Dr. Jacob Hill. Cleveland Clinic researchers and external interested individuals who request this data will be required to follow the data use and sharing policies of the Cleveland Clinic.

Locations

US (1)