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?

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

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.

Is Mindfulness-Based Cognitive Therapy (MBCT) safe for humans?

Research on Mindfulness-Based Cognitive Therapy (MBCT) for various mental disorders, including depression, suggests it is generally safe for humans, with no significant safety concerns reported in the studies. ^{1 2 3 4 5}

How is MBCT different from other treatments for depression in breast cancer survivors?

MBCT (Mindfulness-Based Cognitive Therapy) is unique because it combines mindfulness meditation with cognitive-behavioral techniques to help prevent depression relapse, focusing on teaching patients to stay well in the long-term. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment MBCT for Depression in Breast Cancer Survivors?

Research shows that Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates in people with major depression, suggesting it could help breast cancer survivors with depression by teaching them mindfulness and cognitive-behavioral skills to manage their symptoms. ^{1 3 4 5 7}

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) 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 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]

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 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for residual depressive symptoms and relapse prophylaxis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]