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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mindfulness-based treatment called MINDSET to reduce depression in individuals who have completed cancer treatment. The study aims to determine if this approach can alleviate depressive symptoms in those who have had breast, prostate, or colorectal cancer. It includes two groups: one trying MINDSET and another receiving usual care. Suitable participants have mild to moderately-severe depression, completed cancer treatment within the last two years, and have access to a device like a phone or computer. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for improving mental health after cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness programs, such as MINDSET, are generally safe for people with depression. Studies have found that these programs can help reduce symptoms of depression. Evidence suggests that participants handle mindfulness practices well. The studies reviewed reported no major side effects, indicating that harmful effects are uncommon. While individual experiences may vary, the evidence supports mindfulness programs as a safe option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MINDSET program because it offers a fresh approach to treating depression through mindfulness-based interventions. Unlike traditional treatments like antidepressants or cognitive-behavioral therapy, which focus on chemical balance or changing thought patterns, MINDSET leverages mindfulness techniques to help individuals become more aware of their thoughts and emotions in a non-judgmental way. This approach aims to provide individuals with tools to manage their symptoms by enhancing self-awareness and emotional regulation. Additionally, MINDSET's non-pharmaceutical nature reduces the risk of side effects associated with medications, making it a potentially safer option for some individuals.

What evidence suggests that the MINDSET intervention could be effective for reducing depressive symptoms in post-treatment cancer participants?

Studies have shown that mindfulness-based programs effectively reduce anxiety and depression symptoms in many people. Specifically, mindfulness-based cognitive therapy (MBCT) helps manage depression by improving thought and emotional patterns. Research also shows that mindfulness meditation positively affects depression, even during challenging times like the COVID-19 pandemic. Overall, these mindfulness programs are linked to better mental health, including reduced depression, anxiety, and stress. In this trial, participants will be randomized to receive the MINDSET treatment, which may help reduce depression symptoms in cancer patients after their treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Chelsea Siwik, PhD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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