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

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized control group is to learn about effective treatments for college students experiencing anxiety and/or depression. The main questions this clinical trial aims to answer are: 1) Can mindfulness-based treatments increase retention rates among first-generation college students? 1) Can mindfulness-based treatments decrease anxiety and/or depression among first-generation college students? Participants will be randomly assigned to one of two intervention groups: mindfulness meditation or psychoeducation. Researchers will compare outcomes from each group to explore treatment differences.

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 mindfulness meditation safe for humans?

Mindfulness meditation is generally considered safe, but some people may experience side effects like anxiety or pain. More severe reactions, such as psychosis, are rare and often linked to other factors like the intensity of practice or personal mental health history. Mindfulness-based programs are designed to be adaptable to avoid causing harm. ^{1 2 3 4 5}

How is mindfulness meditation different from other treatments for anxiety and depression?

Mindfulness meditation is unique because it focuses on being fully present and aware without judgment, which helps individuals detach from negative thoughts and emotions. Unlike traditional therapies, it often involves group sessions and combines meditation with psychoeducation to improve mental health. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Mindfulness Meditation and Psychoeducation for anxiety and depression?

Research shows that mindfulness meditation can significantly reduce symptoms of anxiety and depression, with long-term benefits observed in patients with anxiety disorders. Additionally, mindfulness interventions have been found to improve depression in young adults, especially when conducted in group settings. ^{3 10 11 12 13}

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

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]

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 (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]

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) 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-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]

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]

Citations

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

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

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

Three-year follow-up and clinical implications of a mindfulness meditation-based stress reduction intervention in the treatment of anxiety disorders. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Meditation for the management of adjustment disorder anxiety and depression. [2011]

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

Effects of Mindfulness Meditation Intervention on Depressive Symptoms in Emerging Adults: A Systematic Review and Meta-Analysis. [2022]

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

Training Teachers to Deliver Mindfulness-Based Interventions: Learning from the UK Experience. [2022]

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

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

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

What Are Adverse Events in Mindfulness Meditation? [2022]

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

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

9. 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]

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

Mindfulness-based stress reduction for comorbid anxiety and depression: case report and clinical considerations. [2018]

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

Mindfulness-Based Interventions for Anxiety and Depression. [2018]

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

Mindfulness-Based Program for Anxiety and Depression Treatment in Healthcare Professionals: A Pilot Randomized Controlled Trial. [2021]

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

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. [2022]