Mindfulness-Based Intervention for Depression

Overseen By Narissa McCarty, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Severe depression, Suicidal ideation, Schizophrenia, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

76 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MINDSET for depression?

Research on Mindfulness-Based Cognitive Therapy (MBCT), which is similar to MINDSET, shows it can help prevent depression relapse and reduce symptoms. Studies found MBCT to be a promising and cost-effective option for managing depression, especially in older adults. ^{1 2 3 4 5}

Is mindfulness-based cognitive therapy (MBCT) safe for humans?

Mindfulness-based cognitive therapy (MBCT) has been shown to be delivered safely in routine clinical settings, with a low rate of reliable deterioration (3%) comparable to other psychotherapeutic interventions. This suggests that MBCT is generally safe for humans. ^{3 6 7 8 9}

How is the MINDSET treatment different from other treatments for depression?

MINDSET, based on Mindfulness-Based Cognitive Therapy (MBCT), is unique because it combines mindfulness meditation with cognitive therapy techniques to help prevent depression relapse by teaching patients to disengage from negative thought patterns. Unlike standard treatments, it focuses on long-term prevention and is particularly beneficial for those who haven't fully responded to other therapies. ^{8 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.

Research Team

Chelsea Siwik, PhD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Eligibility Criteria

This trial is for individuals who have completed treatment for breast, prostate, or colorectal cancer and are experiencing depressive symptoms. Participants should be interested in a mindfulness-based intervention sent via text messages.

Inclusion Criteria

Access to a web-enabled device (phone, tablet, computer)

Ability to provide informed consent

I have been diagnosed with early-stage breast, prostate, or colorectal cancer.

Exclusion Criteria

Self-reported active mindfulness practice

Self-reported suicidal ideation (>1 on item 9 PHQ-9)

Presence of another psychological, medical, or other condition/issue determined to necessitate priority treatment and/or interfere with participation (e.g., schizophrenia, borderline personality disorder)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily, digital mindfulness-based intervention (MINDSET) for depressive symptoms

8 weeks

Daily digital content delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MINDSET

Trial Overview The study is testing 'MINDSET', a new text message-based mindfulness program designed to alleviate depression in post-treatment cancer patients, compared with Enhanced Usual Care (EUC), which represents the standard support provided.

Participant Groups

Group I: ARM 2 Experimental Treatment 1 Intervention

Participants will be randomized to EUC

Group II: ARM 1 Experimental Treatment 1 Intervention

Participants will be randomized to MINDSET

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Mindfulness-based Cognitive Therapy (MBCT) appears to be a promising and cost-effective intervention for older adults with a history of relapsing major depression, based on a study involving 38 participants aged over 65, with 30 completing the course.

Participants reported that MBCT was helpful in managing their depression, suggesting that it could be a valuable addition to treatment options for older individuals, although further research is needed to refine the approach for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for recurring depression in older people: a qualitative study. Smith, A., Graham, L., Senthinathan, S.[2020]

In a study of 274 participants with a history of recurrent major depressive disorder, mindfulness-based cognitive therapy (MBCT) did not significantly reduce the overall risk of relapse compared to cognitive psychological education (CPE) or treatment as usual (TAU) over a 12-month follow-up period.

However, MBCT was particularly beneficial for individuals with a history of childhood trauma, showing a significant reduction in relapse risk compared to TAU and CPE for those with higher trauma severity, indicating that MBCT may be more effective for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. Williams, JM., Crane, C., Barnhofer, T., et al.[2022]

Mindful Mood Balance (MMB), a web-based version of Mindfulness-based Cognitive Therapy (MBCT), was effective in reducing depressive symptoms and rumination in a study of 100 recurrently depressed individuals over an 8-session program with a 6-month follow-up.

Participants using MMB showed significant improvements in depressive severity and mindfulness compared to those receiving usual depression care, indicating that web-based delivery of MBCT can be beneficial for individuals with a history of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Dimidjian, S., Beck, A., Felder, JN., et al.[2022]

In a study involving 1554 participants across five UK mental health services, mindfulness-based cognitive therapy (MBCT) was found to be effective in preventing depressive relapse, with 96% of those who entered treatment in the non-depressed range maintaining their recovery.

For participants who entered with current depression, 45% achieved recovery, and there was a significant reduction in overall depression severity, indicating that MBCT is being delivered safely and effectively in real-world settings, even beyond its original target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. Tickell, A., Ball, S., Bernard, P., et al.[2021]

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) was found to be acceptable for patients currently experiencing major depression who had not fully responded to standard treatments, indicating its potential as an alternative intervention.

The therapy led to a significant improvement in depression scores, with a pre-post effect size of 1.04, suggesting that many participants experienced a return to normal or near-normal mood levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Kenny, MA., Williams, JM.[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]

References

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

Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for recurring depression in older people: a qualitative study. [2020]

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

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. [2022]

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

The correlation between mindfulness and negative automatic thoughts in depression patients. [2021]

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

Added value of Mindfulness-Based Cognitive Therapy for Depression: A Tree-based Qualitative Interaction Analysis. [2020]

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

Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. [2022]

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

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. [2021]

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

The long-term effects of mindfulness-based cognitive therapy as a relapse prevention treatment for major depressive disorder. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness-based cognitive therapy in relation to prior history of depression: randomised controlled trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for the treatment of current depressive symptoms: a meta-analysis. [2020]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. [2022]

13. Denmark pubmed.ncbi.nlm.nih.gov

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