Mindfulness Meditation for Anxiety and Depression

Overseen By Natalie Lecy

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Dakota

Disqualifiers: Non-college enrollment, Non-first-generation, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness meditation can reduce anxiety and depression in first-generation college students. Participants will join one of two groups: one will practice mindfulness meditation, while the other will engage in psychoeducation sessions (educational sessions about psychological topics). The trial seeks to identify which method more effectively reduces anxiety and depression and increases retention rates. This trial suits first-generation college students in the U.S. with regular internet access and a device like a smartphone or computer. As an unphased trial, it offers a unique opportunity to explore effective methods for enhancing mental health and academic success.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

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

Research has shown that mindfulness meditation is usually safe, though some studies find that 25-87% of participants might experience negative effects, such as increased anxiety or difficulty concentrating. About 3-37% report that these issues affect their daily life.

On the positive side, mindfulness meditation can reduce stress and improve depression symptoms. One study found it as effective as a common anxiety medication for treating anxiety disorders.

For psychoeducation, detailed safety information is limited, but it is generally considered low-risk. Psychoeducation involves learning about mental health and coping strategies, which is usually safe.

In summary, both mindfulness meditation and psychoeducation are generally safe, but awareness of possible negative effects, especially with meditation, is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for anxiety and depression, which often include medication and cognitive behavioral therapy, mindfulness meditation offers a unique approach by encouraging individuals to focus on the present moment and develop greater awareness of their thoughts and feelings. This technique can be particularly appealing because it is non-invasive and can be practiced anywhere, providing a flexible and accessible option for many people. Researchers are excited about mindfulness meditation because it has the potential to empower individuals to manage their symptoms naturally, possibly reducing reliance on medication and enhancing overall well-being. Additionally, the psychoeducation component complements this by providing valuable information about mental health, helping participants better understand and manage their conditions.

What evidence suggests that this trial's treatments could be effective for anxiety and depression?

Research has shown that mindfulness meditation, which participants in this trial may receive, can help reduce anxiety and depression. One study found it fairly effective in improving anxiety and mood. Another study showed that it reduces anxiety similarly to some medications. During the COVID-19 pandemic, mindfulness meditation also helped improve depressive symptoms. Additionally, it has proven as effective as some therapies for reducing PTSD and depression. These findings suggest that mindfulness meditation could benefit college students dealing with anxiety and depression. Meanwhile, another group in this trial will receive psychoeducation, involving online recordings to support mental health. ^{1 2 4 6 7}

Who Is on the Research Team?

Natalie Lecy

Principal Investigator

University of South Dakota

Are You a Good Fit for This Trial?

This trial is for first-generation college students in rural areas who are struggling with anxiety and/or depression. Participants should be interested in exploring mindfulness-based treatments to potentially improve their mental health and increase their chances of staying in school.

Inclusion Criteria

Currently enrolled in a four-year college in the United States

First-generation college student

Access to WiFi and a computer/smartphone/tablet

Exclusion Criteria

Non-English speaker

Not able to utilize WiFi or computer/tablet/smartphone

Not currently enrolled in a four-year college

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mindfulness meditation or psychoeducation once a week for four weeks

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for changes in intention to persist in college, anxiety, and depression

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation
• Psychoeducation

Trial Overview The study is testing two different interventions: mindfulness meditation and psychoeducation, to see which one might better help reduce anxiety and depression among these students. It's a randomized control trial, meaning participants will be placed into either group by chance.

How Is the Trial Designed?

Group I: Mindfulness Meditation Experimental Treatment 1 Intervention

Participants will meet virtually with the mindfulness practitioner once a week for four weeks for 30-minute segments.

Group II: Psychoeducation Active Control 1 Intervention

Participants will receive recordings online, once a week for four weeks which will be approximately 30 minutes in length.

Who Is Running the Clinical Trial?

University of South Dakota

Lead Sponsor

Trials

16

Recruited

2,000+

Mind and Life Institute, Hadley, Massachusetts

Collaborator

Trials

17

Recruited

1,600+

Published Research Related to This Trial

Mindfulness-based approaches have been shown to effectively prevent depressive relapse and recurrence, leading to their recommendation by the UK's National Institute for Health and Clinical Excellence for use in the National Health Service.

There is growing evidence that mindfulness can also benefit individuals with anxiety disorders and chronic physical health issues, prompting interest in its application for other conditions like personality disorders and substance abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Teachers to Deliver Mindfulness-Based Interventions: Learning from the UK Experience. Crane, RS., Kuyken, W., Hastings, RP., 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]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction and mindfulness-based cognitive therapy, have been shown to effectively reduce symptoms of anxiety and depression across various populations.

MBIs consistently outperform non-evidence-based treatments and are comparable in efficacy to cognitive behavior therapy (CBT), indicating their strong potential as a therapeutic option for mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Anxiety and Depression. Hofmann, SG., Gómez, AF.[2018]

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]

A survey of 129 stakeholders across 20 healthcare regions in Sweden revealed that while Mindfulness-Based Programs (MBPs) are being implemented, there is significant variation in the models used and modifications to evidence-based practices.

Key factors for successful MBP implementation include having a supportive leader and a champion for the program, while challenges such as time constraints and funding shortages hinder effective rollout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. Niemi, M., Crane, R., Sinselmeijer, J., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2848393/

The Effect of Mindfulness-Based Therapy on Anxiety and ... Effect size estimates suggest that mindfulness-based therapy was moderately effective for improving anxiety (Hedges' g = 0.63) and mood symptoms (Hedges' g = 0 ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2798510

Mindfulness-Based Stress Reduction vs Escitalopram for ... Mindfulness meditation has been found to help reduce anxiety; a recent meta-analysis8 of trials with anxiety disorders found a significant benefit with ...

3. nature.com nature.com/articles/s41598-024-71213-9

The effect of mindfulness meditation on depressive ... The findings suggest a positive effect of mindfulness meditation on depressive symptoms in individuals with depression during the COVID-19 pandemic.

4. pcori.org pcori.org/research-results/2017/comparing-meditation-versus-medicine-patients-anxiety-disorders

Comparing Meditation versus Medicine for Patients with ... Meditation can also help reduce anxiety. In this project, the research team compared two treatments for patients with anxiety disorders: Mindfulness-based ...

5. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH The results of the study showed that meditation was as effective as prolonged exposure therapy at reducing PTSD symptoms and depression, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352250X25002106

Adverse Effects of Meditation and Mindfulness in Clinical ... Recent studies reveal that 25-87% of those who engage in meditation report adverse effects (AEs), with 3-37% experiencing functional impairment ...

7. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Researchers reviewed more than 200 studies of mindfulness among healthy people and found mindfulness-based therapy was especially effective for reducing stress ...