Meditation for Psychological Distress

Overseen By Thaddeus Pace, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Must not be taking: Corticosteroids

Disqualifiers: Asthma, Regular meditation experience, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

192 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using corticosteroids for an illness like asthma, you may not be eligible to participate.

What data supports the effectiveness of the treatment 10-day meditation intervention, Mindfulness Meditation, Transcendental Meditation, Meditation Therapy for psychological distress?

Research shows that meditation interventions, including Mindfulness and Transcendental Meditation, can reduce stress and improve psychological functioning. For example, a study found that Transcendental Meditation significantly reduced stress symptoms in disaster-affected individuals, and another study indicated that mindfulness-based courses improved mindfulness and reduced cognitive lapses. ^{1 2 3 4 5}

Is meditation generally safe for humans?

Meditation is generally considered safe, but some people may experience side effects like anxiety, pain, or more severe reactions such as psychosis, especially if they have a history of mental health issues. These reactions can depend on the intensity and duration of the meditation practice, and it's important for programs to be adapted to individual needs to avoid harm. ^{6 7 8 9 10}

How does the 10-day meditation intervention differ from other treatments for psychological distress?

The 10-day meditation intervention, which includes practices like Mindfulness Meditation and Transcendental Meditation, is unique because it can quickly reduce psychological distress by promoting mindfulness and resilience, often within just 10 days. Unlike some standard therapies, it is a non-drug, cost-effective approach that can be easily integrated into daily life and has shown significant benefits in reducing symptoms of stress and anxiety. ^{11 12 13 14 15}

What is the purpose of this trial?

The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).

Research Team

Thaddeus Pace, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for career firefighters aged 18 or older who speak English and own a smartphone. It's not suitable for those with illnesses requiring corticosteroids like asthma, or anyone with regular meditation experience in the last four years.

Inclusion Criteria

Currently employed as a career firefighter

Speak and understand English

Own a smartphone (iPhone or Android) able to download and run the intervention apps

Exclusion Criteria

I use corticosteroids for a condition like asthma.

Have ongoing or past regular meditation experience in the last 4 years (i.e. more than two meditation sessions [completed or attempted] per year either with a group or individually), as determined by the PI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 10-day meditation intervention or a 10-day health education intervention via smartphone app

10 days

Follow-up

Participants are monitored for psychological distress reduction at 10 days, 30 days, and 3 months after the intervention

3 months

Treatment Details

Interventions

• 10-day meditation intervention

Trial Overview The study tests a 10-day meditation program delivered via an app to reduce anxiety and depression among firefighters, comparing it to a health education intervention over the same period.

Participant Groups

Group I: 10-day meditation intervention Experimental Treatment 1 Intervention

prerecorded meditation units, 10 units, one per day, delivered by smartphone app

Group II: 10-day health education intervention Active Control 1 Intervention

prerecorded health education units, 10 units, one per day, delivered by smartphone app

10-day meditation intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Meditation Therapy for:

• Anxiety
• Depression
• Stress Relief

Approved in European Union as Mindfulness Meditation for:

• Stress Management
• Anxiety Reduction
• Mental Health Support

Approved in Canada as Transcendental Meditation for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety
• Depression

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Findings from Research

Restoration skills training (ReST) participants maintained higher levels of dispositional mindfulness and experienced fewer cognitive lapses six months after completing the course, indicating lasting psychological benefits.

Compared to conventional mindfulness training (CMT), ReST participants were more likely to continue practicing mindfulness regularly, which was associated with sustained improvements in their psychological functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration Skills Training in a Natural Setting Compared to Conventional Mindfulness Training: Sustained Advantages at a 6-Month Follow-Up. Lymeus, F., White, MP., Lindberg, P., et al.[2022]

An 8-week mindfulness meditation program significantly improved emotional well-being and reduced psychological distress in 21 participants with chronic illnesses, showing moderate-to-large effect sizes.

Participants reported high adherence to the meditation practice and satisfaction with its benefits, suggesting that mindfulness could be a valuable complementary approach alongside traditional psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does mindfulness meditation contribute to health? Outcome evaluation of a German sample. Majumdar, M., Grossman, P., Dietz-Waschkowski, B., et al.[2010]

Transcendental Meditation (TM) was found to be non-inferior to prolonged exposure therapy (PE) in reducing PTSD symptoms among veterans, indicating that TM can be an effective alternative treatment.

Both TM and PE significantly outperformed PTSD health education (HE), with 61% of TM participants showing clinically significant improvements compared to 42% for PE and 32% for HE, suggesting TM's potential as a preferred option for veterans who may not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. Nidich, S., Mills, PJ., Rainforth, M., et al.[2019]

Meditation interventions significantly reduced cortisol levels in at-risk populations, such as patients with somatic illnesses, showing a medium effect compared to control groups in 10 studies using blood samples.

While the effect was smaller and not significant in 21 studies using saliva samples, there was a marginally significant reduction in cortisol for individuals in stressful life situations, indicating that meditation may be particularly beneficial for those facing higher stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation interventions efficiently reduce cortisol levels of at-risk samples: a meta-analysis. Koncz, A., Demetrovics, Z., Takacs, ZK.[2021]

In a study involving 171 residents from areas affected by the 2011 Japan earthquake and tsunami, those who learned Transcendental Meditation showed a significant reduction in self-reported stress symptoms compared to a no-treatment control group, with a strong effect size of -1.09.

The results indicate that Transcendental Meditation may be an effective intervention for alleviating trauma-related stress in disaster-affected populations, as evidenced by the significant drop in total symptom scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DISASTER RELIEF FOR THE JAPANESE EARTHQUAKE-TSUNAMI OF 2011: STRESS REDUCTION THROUGH THE TRANSCENDENTAL MEDITATION® TECHNIQUE. Yoshimura, M., Kurokawa, E., Noda, T., et al.[2015]

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]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

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 study involving 2155 participants found that Mindfulness-Based Stress Reduction (MBSR) does not increase rates of harm compared to a waitlist control group, indicating its safety as a stress-reduction method.

MBSR may actually protect against various psychological and physical symptoms, suggesting it could be beneficial for mental health rather than harmful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of harm in mindfulness-based stress reduction. Hirshberg, MJ., Goldberg, SB., Rosenkranz, M., et al.[2023]

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]

Mantram repetition, an ancient mindfulness practice, has been shown to effectively reduce psychological distress symptoms such as depression and anxiety, with a small overall effect size of 0.23 based on 12 studies.

This intervention is portable and cost-effective, outperforming standard therapies, suggesting it could be a valuable tool for practitioners to teach patients for managing daily stress and enhancing resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mantram repetition and psychological distress: A systematic review and meta-analysis. Schneider, JK., Abdullahi, SG., Easton, SD., et al.[2023]

A study involving 332 healthy adults found that different types of meditation training (mindfulness, compassion, and perspective-taking) have specific effects on alleviating psychological distress, rather than shared benefits across all types.

Machine learning analysis showed that mindfulness training (Presence) effectively reduced distress differently than compassion training (Affect), indicating that tailored meditation interventions can be chosen based on individual distress patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential reduction of psychological distress by three different types of meditation-based mental training programs: A randomized clinical trial. Liebmann, C., Konrad, AC., Singer, T., et al.[2023]

Mindfulness-based programs (MBPs) significantly reduce psychological distress in adults, showing a small to moderate effect size in a meta-analysis of 15 trials involving 2,371 participants from 8 countries.

The effectiveness of MBPs was consistent across various demographics, including baseline distress levels, gender, age, education, and dispositional mindfulness, indicating broad applicability of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. Galante, J., Friedrich, C., Dalgleish, T., et al.[2023]

Transcendental Meditation (TM) significantly reduced posttraumatic stress symptoms in Congolese refugees, with average PTSD Checklist scores dropping from 77.9 to 48.0 within just 10 days after instruction.

The study involved 11 participants and showed a high effect size (d = 4.05) for symptom reduction, with no adverse events reported, indicating TM is a safe and effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant reductions in posttraumatic stress symptoms in Congolese refugees within 10 days of Transcendental Meditation practice. Rees, B., Travis, F., Shapiro, D., et al.[2014]

Natural Stress Relief meditation, practiced for 15 minutes twice a day, significantly reduces trait anxiety, with notable improvements observed after just one week (Cohen d=0.46) and further reductions after two weeks (Cohen d=0.67).

The meditation technique requires only one hour of initial training and is self-administered, making it an accessible method for individuals seeking to manage stress and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of natural stress relief meditation on trait anxiety: a pilot study. Coppola, F.[2015]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Restoration Skills Training in a Natural Setting Compared to Conventional Mindfulness Training: Sustained Advantages at a 6-Month Follow-Up. [2022]

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

Does mindfulness meditation contribute to health? Outcome evaluation of a German sample. [2010]

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

Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. [2019]

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

Meditation interventions efficiently reduce cortisol levels of at-risk samples: a meta-analysis. [2021]

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

DISASTER RELIEF FOR THE JAPANESE EARTHQUAKE-TSUNAMI OF 2011: STRESS REDUCTION THROUGH THE TRANSCENDENTAL MEDITATION® TECHNIQUE. [2015]

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

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

7. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

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

What Are Adverse Events in Mindfulness Meditation? [2022]

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

Prevalence of harm in mindfulness-based stress reduction. [2023]

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

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

11. England pubmed.ncbi.nlm.nih.gov

Mantram repetition and psychological distress: A systematic review and meta-analysis. [2023]

12. Spain pubmed.ncbi.nlm.nih.gov

Differential reduction of psychological distress by three different types of meditation-based mental training programs: A randomized clinical trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. [2023]

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

Significant reductions in posttraumatic stress symptoms in Congolese refugees within 10 days of Transcendental Meditation practice. [2014]

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

Effects of natural stress relief meditation on trait anxiety: a pilot study. [2015]