MBCT for Depression in Breast Cancer Survivors

Overseen By Jacob Hill, ND

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Antidepressants

Disqualifiers: Severe depression, Anxiety, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method to improve mood and reduce depression in breast cancer survivors. The treatment, Mindfulness-Based Cognitive Therapy (MBCT), involves group sessions conducted over the phone or online. Participants engage in meditation and therapy exercises to enhance mental well-being. The trial seeks African American/Black women who have experienced Stage I, II, or III breast cancer, are at least three months past active cancer treatment, and exhibit mild to moderate depression symptoms. As an unphased trial, this study provides a unique opportunity to explore innovative mental health support tailored to participants' needs.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that there are no changes in antidepressant medication within 6 weeks before starting the trial.

What prior data suggests that Mindfulness-Based Cognitive Therapy is safe for breast cancer survivors?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT) is generally well-received by people with depression, especially cancer survivors. Studies have found that MBCT can improve quality of life by reducing symptoms of depression and anxiety. This therapy includes mindfulness exercises and cognitive therapy techniques, which are usually safe. Participants in various studies reported positive mental health outcomes without major negative effects. Overall, MBCT appears to be a safe way to manage depression, with the benefits outweighing the risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional treatments for depression in breast cancer survivors, which often involve medication and psychotherapy, Mindfulness-Based Cognitive Therapy (MBCT) offers a non-pharmacological approach that combines meditation with cognitive therapy techniques. Researchers are excited about MBCT because it empowers patients to actively participate in their own mental health care through mindfulness practices. Delivered through flexible options like telephone or video calls, MBCT can easily fit into a patient's lifestyle, making it accessible and convenient. This approach not only targets depressive symptoms but also enhances overall well-being by encouraging daily mindfulness exercises.

What evidence suggests that MBCT might be an effective treatment for depression?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT), which participants in this trial will receive, can help reduce depression and anxiety in breast cancer patients. Studies have found that MBCT improves mood by teaching patients to focus on the present and manage negative thoughts. Patients who practice MBCT often feel less anxious, experience less pain, and enjoy a better quality of life. Evidence also supports that MBCT effectively reduces psychological distress, including depression, in cancer patients. These findings suggest that MBCT could be a promising way to manage depression in breast cancer survivors. ^{2 4 6 7 8}

Who Is on the Research Team?

Jacob Hill, ND

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for African American/Black women over 65 with mild to moderate depression and a history of Stage I, II or III breast cancer. They must speak English, have completed cancer treatment at least 3 months ago (except endocrine therapy), and be willing to consent to audio and video recording. Excluded are those with severe depression, recent changes in antidepressants, certain psychiatric conditions, daily meditation practice, or prior mindfulness training.

Inclusion Criteria

I am 65 years old or older.

African American/Black

Fluency in English

Exclusion Criteria

I have participated in mindfulness or stress reduction therapies before.

I meditate every day.

I have been diagnosed with severe depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MBCT-Brief intervention, which includes 8 weekly 1-hour group sessions delivered via telephone or video teleconferencing

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in quality of life, depressive symptoms, fear of recurrence, and trait mindfulness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MBCT

Trial Overview The study is testing an abbreviated form of Mindfulness-Based Cognitive Therapy (MBCT) designed to improve mood and reduce symptoms of depression in older African American/Black breast cancer survivors.

How Is the Trial Designed?

Group I: Mindfulness-Based Cognitive Therapy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness-based cognitive therapy (MBCT) is designed specifically for individuals at risk of depressive relapse, helping them learn strategies to maintain long-term mental wellness.

The article reviews existing research on the effectiveness of MBCT, highlighting its potential as a valuable psychological intervention for preventing future episodes of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. Williams, JM., Kuyken, W.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the risk of relapse or recurrence of major depressive disorder (MDD) by 34%, based on a meta-analysis of six randomized controlled trials involving 593 participants.

For patients with three or more previous episodes of MDD, MBCT offers a 43% reduction in relapse risk and is at least as effective as maintenance antidepressant medication, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Piet, J., Hougaard, E.[2022]

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

Mindfulness-based Cognitive Therapy (MBCT) is effective in helping participants with depression develop skills, increase awareness, and gain a sense of agency over their experiences, as shown in a systematic review of 21 qualitative studies.

Participants reported a mix of acceptance and ambivalence towards their mindfulness practices, indicating that while MBCT can lead to meaningful change, it may also present challenges for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. Williams, K., Hartley, S., Langer, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10288664/

Immediate impact of Mindfulness-Based Cognitive Therapy ... Our study provides evidence that MBCT has benefits for patients with breast cancer in terms of alleviating anxiety, pain, and depression and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925002764

Mindfulness-based interventions for cancer patients in ... Studies synthesized in this meta-analysis showed that MBIs have positive outcomes, namely increased quality of life, and reduced depression and anxiety symptoms ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40071356

Effects of Mindfulness Therapy on Breast Cancer Patients ... This study provides scientific evidence and practical guidance for psychological care in breast cancer patients, supporting the effectiveness of ...

4. nature.com nature.com/articles/s41598-025-85745-1

An examination of the effectiveness of mindfulness ... Based on the results of this study, it can be concluded that MICBT therapy is effective in reducing depression, anxiety, and stress and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392420301032

Mindfulness-Based Cognitive Therapy for Psychological ... The present study demonstrated that our MBCT intervention significantly reduced psychological distress (both anxiety and depression) in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7004073/

Internet‐delivered mindfulness‐based cognitive therapy for ... Our preliminary findings suggest iMBCT to be a helpful intervention for cancer survivors suffering from symptoms of anxiety. Further studies on the efficacy for ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32105790/

Mindfulness-Based Cognitive Therapy for Psychological ... Results: The participants in the MBCT group experienced significantly better outcomes in their psychological distress (Cohen's d = 1.17; P < 0.001), FCR (d = ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03972020?tab=table

Mindfulness Based Intervention vs Cognitive Behavioral ... Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms, sleep, fatigue, disease adaptation and stress ...