Meditation for Mental Health Issues

Recruiting at 1 trial location

Overseen By AZA Allsop, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Psychosis, Seizure disorder, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Music Mindfulness Program, Music-Based Mindfulness Intervention, Virtual Music Mindfulness Program, Music-Backed Guided Mindfulness Meditation for mental health issues?

Research shows that mindfulness-based interventions, often combined with music therapy, can help reduce stress and depression in patients, including those with cancer and psychiatric disorders. Mindfulness-based cognitive therapy has also been effective in reducing psychiatric hospitalizations among veterans with mental health issues. ^{1 2 3 4 5}

Is mindfulness meditation safe for mental health issues?

Mindfulness meditation is generally considered safe, but some people may experience anxiety, pain, or more severe reactions like psychosis, especially if they have a history of mental health issues. These reactions are often related to the intensity and duration of meditation practices, and more research is needed to fully understand and prevent potential harm. ^{6 7 8 9 10}

How is the Music Mindfulness Program treatment different from other treatments for mental health issues?

The Music Mindfulness Program is unique because it combines music with mindfulness meditation, offering a novel approach that integrates auditory elements to enhance the mindfulness experience, unlike traditional mindfulness practices that may not include music. ^{4 11 12 13 14}

Research Team

AZA Allsop, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

This study is for People of African Descent (PADs) in America who are experiencing stress, anxiety, or depression during COVID-19. It aims to help those affected by racism and socioeconomic challenges. Participants should be interested in meditation and mindfulness.

Inclusion Criteria

I have been diagnosed with anxiety or depression.

Exclusion Criteria

PHQ-9 <9, GAD7 <9

Suicidal ideation, self-injurious behavior, or homicidal ideation at screening

I have a history of thyroid or heart disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in an 8-week music-backed guided mindfulness meditation program, attending weekly sessions and listening to virtual guided meditations.

8 weeks

8 visits (in-person or virtual), weekly sessions

Follow-up

Participants are monitored for feedback and effectiveness through a focus group after the intervention.

1 week

1 visit (virtual)

Treatment Details

Interventions

• Music Mindfulness Program

Trial Overview The trial examines how effective music-backed guided mindfulness meditation is compared to guided meditation alone for reducing stress, anxiety, and depression among PADs. The study includes both virtual and in-person sessions using headphones.

Participant Groups

Group I: Virtual participation Experimental Treatment 1 Intervention

Cohort 3 will be participating virtually by following along to the guided meditation via a password-protected Zoom room. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

Group II: In person with live music Experimental Treatment 1 Intervention

Cohort 1 will be guided through in-person meditation. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

Group III: In person with headphones Experimental Treatment 1 Intervention

Cohort 2 (also in-person) will experience this same meditation as Cohort 1 concurrently through headphones (in a space separate from Cohort 1). Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A therapeutic education program based on mindfulness was developed in the 1990s to help combat depression and generalized anxiety disorder, focusing on being present without judgment.

In France, this program will be implemented in psychiatry, using meditation and psychoeducation to help patients with depression detach from their psychological and emotional content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating depression through mindfulness-based cognitive therapy]. Dulong, F.[2018]

A study of 98 veterans with psychiatric disorders showed that while attendance in mindfulness-based cognitive therapy (MBCT) was low (average of 4.87 out of 8 sessions), those who attended had a significant reduction in psychiatric hospitalizations after the intervention.

Despite the challenges in implementing MBCT due to high dropout rates, the results suggest that MBCT could be beneficial for veterans at high risk for psychiatric hospitalization, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. Marchand, WR., Yabko, B., Herrmann, T., et al.[2020]

A 10-day online mindfulness-based stress reduction program combined with music therapy significantly reduced stress and depression levels in 120 cancer patients compared to a control group.

Participants in the intervention group also reported improved psychological well-being, indicating that this combined approach can be an effective psychological intervention for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Mindfulness-Based Stress Reduction Program on Stress, Depression, and Psychological Well-being in Patients With Cancer: A Single-Blinded Randomized Controlled Trial. Yildirim, D., Çiriş Yildiz, C., Ozdemir, FA., et al.[2023]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

Mindfulness-based therapies, particularly Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have been shown to effectively improve psychological health, manage pain, and reduce anxiety symptoms.

MBCT is specifically recommended as an additional treatment for unipolar depression, highlighting its role in supporting mental health alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. Marchand, WR.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

While mindfulness-based programs (MBPs) are known for their benefits, the potential for harm has not been thoroughly investigated, indicating a need for more research in this area.

The study identifies three key factors that may contribute to harm in MBPs: program-related factors, participant-related factors, and clinician-related factors, suggesting that understanding these can help improve safety and effectiveness in future mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Baer, R., Crane, C., Miller, E., et al.[2023]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

Web-based mindfulness interventions were effective in reducing depression and anxiety in clinical populations, with significant improvements noted in overall anxiety (g=-0.433) and in the anxiety disorder subgroup (g=-0.719) based on a systematic review of 12 studies involving 756 participants.

These interventions also enhanced quality of life and mindfulness skills, particularly benefiting those with clinical anxiety, although they showed limited effectiveness for depression specifically in the depression disorder subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. Sevilla-Llewellyn-Jones, J., Santesteban-Echarri, O., Pryor, I., et al.[2020]

The e-mental health intervention 'CoPE It' significantly reduced psychological distress, anxiety, and depressive symptoms among 110 participants during the COVID-19 pandemic, demonstrating its effectiveness in improving mental health.

Participants reported high satisfaction with the 'CoPE It' program, with 95.83% finding it easy to use, indicating strong usability and feasibility of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the E-Mental Health Mindfulness-Based and Skills-Based "CoPE It" Intervention to Reduce Psychological Distress in Times of COVID-19: Results of a Bicentre Longitudinal Study. Bäuerle, A., Jahre, L., Teufel, M., et al.[2021]

Mobile mindfulness meditation (MMM) significantly reduces stress and anxiety among university students, with a standardized mean difference of -0.41 for stress and -0.29 for anxiety, based on a meta-analysis of 10 studies involving 958 participants.

MMM also enhances well-being and mindfulness, showing a positive effect size of 0.30 for well-being and a remarkable 2.66 for mindfulness, although it did not significantly impact resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mobile Mindfulness Meditation on the Mental Health of University Students: Systematic Review and Meta-analysis. Chen, B., Yang, T., Xiao, L., et al.[2023]

A randomized controlled trial with 50 university students showed that mindfulness training delivered via videoconference significantly reduced depression more than podcast-based training over a 7-week period.

Both interventions effectively increased mindfulness and life satisfaction, but the benefits of home practice were notably stronger in the videoconferencing group, suggesting its potential as a valuable tool for addressing mental health issues during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of online mindfulness-based interventions in a university student sample: Videoconference- or podcast-delivered intervention. Karing, C.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treating depression through mindfulness-based cognitive therapy]. [2018]

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

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. [2020]

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

Effects of a Mindfulness-Based Stress Reduction Program on Stress, Depression, and Psychological Well-being in Patients With Cancer: A Single-Blinded Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. [2022]

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

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. [2022]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

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

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. [2018]

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

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

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

What Are Adverse Events in Mindfulness Meditation? [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the E-Mental Health Mindfulness-Based and Skills-Based "CoPE It" Intervention to Reduce Psychological Distress in Times of COVID-19: Results of a Bicentre Longitudinal Study. [2021]

13. Canada pubmed.ncbi.nlm.nih.gov

Effects of Mobile Mindfulness Meditation on the Mental Health of University Students: Systematic Review and Meta-analysis. [2023]

14. England pubmed.ncbi.nlm.nih.gov

The efficacy of online mindfulness-based interventions in a university student sample: Videoconference- or podcast-delivered intervention. [2023]