Yoga and Self-Compassion for Stress

(I-YMSC Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Pregnancy, Psychotic disorders, Severe substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

11 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your psychiatric treatments (medication or therapy) have not been stable for the last 8 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Integrative Hatha Yoga and Mindful Self-Compassion Program for stress?

Research shows that both yoga and mindfulness meditation can reduce stress by increasing self-compassion, which is a strong predictor of stress reduction. Additionally, a study found that integrative yoga, which combines physical exercises and mindfulness, led to significant stress reduction in adults with elevated stress levels. ^{1 2 3 4 5}

Is yoga and self-compassion safe for stress management?

A systematic review of yoga found no significant differences in serious adverse events compared to usual care or exercise, suggesting it is generally safe. However, there were more nonserious adverse events compared to psychological or educational interventions. ^{1 6 7 8 9}

How does the Integrative Hatha Yoga and Mindful Self-Compassion Program treatment differ from other treatments for stress?

This treatment is unique because it combines yoga with the Mindful Self-Compassion (MSC) program, which focuses on increasing self-compassion through practices like meditation and self-kindness exercises. Unlike other stress treatments, it emphasizes a holistic approach that integrates physical movement with mental and emotional self-care. ^{1 10 11 12 13}

What is the purpose of this trial?

Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.

Eligibility Criteria

This trial is for women who have survived interpersonal violence and are experiencing stress. It's a small study with only 15 participants to see how well they respond to a special program combining yoga and self-compassion techniques.

Inclusion Criteria

I have access to a telephone.

Report being distressed, defined by a score of >5 on the Kessler-6 screener

Speak and understand English well enough to understand questionnaires when they are read aloud

Exclusion Criteria

Pregnancy

Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

Moderate or high risk for suicide on the adapted Columbia Suicide Severity Rating Scale screen version-recent (C-SSRS) and/or endorsement of suicidal plan/intent in the past 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week adapted integrative hatha yoga and mindful self-compassion program

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Integrative Hatha Yoga and Mindful Self-Compassion Program

Trial Overview The study is testing an adapted integrative hatha yoga and mindful self-compassion program designed specifically for these women. Since it's an open, single-arm pilot trial, all participants will receive the same intervention without comparison groups.

Participant Groups

Group I: Experimental: Integrative hatha yoga and mindful self-compassion Experimental Treatment 1 Intervention

12 weeks of adapted, integrative yoga and mindful self-compassion specifically designed to be administered to women survivors of interpersonal violence.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

In a study involving 92 college students over 10 weeks, both yoga and mindfulness meditation were found to positively impact self-compassion, mindfulness, and perceived stress levels.

The strongest predictor of stress reduction was an increase in self-compassion, suggesting that enhancing self-compassion could improve the effectiveness of mind-body interventions for student well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A naturalistic study of yoga, meditation, self-perceived stress, self-compassion, and mindfulness in college students. Gorvine, MM., Zaller, ND., Hudson, HK., et al.[2022]

In a study involving 102 adults with high stress levels, all three interventions—integrative yoga, Iyengar yoga, and mindfulness training—led to significant reductions in perceived stress after 12 weeks, with large effect sizes indicating their effectiveness.

There were no significant differences in stress reduction among the three groups, suggesting that each method is equally effective, and the choice of intervention should depend on individual preferences and availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Reduction by Yoga versus Mindfulness Training in Adults Suffering from Distress: A Three-Armed Randomized Controlled Trial including Qualitative Interviews (RELAX Study). Fischer, JM., Kandil, FI., Kessler, CS., et al.[2023]

Hatha yoga, through its combination of physical postures and breathing techniques, promotes both physical and emotional balance, demonstrating the effectiveness of mind-body therapies.

Meditation and guided imagery complement hatha yoga by enhancing self-awareness and emotional well-being, suggesting their potential as valuable adjunctive therapies for overall wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga, meditation, and imagery: clinical applications. Gimbel, MA.[2019]

An 8-week Hatha Yoga program significantly improved anxiety levels, self-compassion, and pain catastrophizing in 10 inpatients at a rehabilitation hospital, indicating its potential as a therapeutic intervention.

The study highlights the effectiveness of modified yoga practices for individuals with limited mobility, suggesting that such interventions can enhance psychological well-being and pain management in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. Curtis, K., Kuluski, K., Bechsgaard, G., et al.[2022]

The Yoga4Health program, designed for patients at risk of health conditions, was well-accepted by participants, with 82.5% being female and a mean age of 53, showing significant psychological, physical, and social benefits post-intervention.

Participants reported increased confidence in managing their health and made positive lifestyle changes, although maintaining practice after the program ended was a challenge, highlighting the importance of structured classes for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Joining a group was inspiring': a qualitative study of service users' experiences of yoga on social prescription. Cheshire, A., Richards, R., Cartwright, T.[2022]

A significant portion of young adults (43.9%) reported experiencing adverse childhood events, which were linked to higher stress levels, highlighting a critical public health concern.

Despite the challenges faced, 12.7% of the young adults practiced yoga for at least 30 minutes a week, with those exposed to adverse events practicing yoga at equal or greater rates than their peers, suggesting yoga could be a beneficial coping strategy for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. Neumark-Sztainer, D., Wall, MM., Choi, J., et al.[2020]

In a study of 52 Hatha Yoga practitioners, advanced practitioners (over 5 years of experience) demonstrated significantly higher mindfulness and lower stress levels compared to beginners (under 5 years of experience).

There was a strong negative correlation between mindfulness and stress levels, suggesting that increased mindfulness through practices like Hatha Yoga may effectively reduce stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and levels of stress: a comparison of beginner and advanced Hatha Yoga practitioners. Brisbon, NM., Lowery, GA.[2021]

In a study of 42 participants, yoga interventions led to a significant decrease in stress reactivity over 12 weeks, suggesting that yoga can effectively help manage stress levels.

Increased psychosocial mechanisms such as mindfulness, interoceptive awareness, spiritual well-being, and self-compassion were associated with reductions in perceived stress, indicating that targeting these areas in yoga programs may enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does yoga reduce stress? A clinical trial testing psychological mechanisms. Park, CL., Finkelstein-Fox, L., Sacco, SJ., et al.[2023]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Self-compassion, which includes self-kindness, common humanity, and mindfulness, is linked to better mental health and less psychological distress, highlighting its importance in emotional well-being.

The Mindful Self-Compassion (MSC) program, an 8-week course with weekly sessions, effectively teaches participants to develop self-compassion through various meditative and practical exercises, demonstrating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion in clinical practice. Germer, CK., Neff, KD.[2013]

The Mindful Self-Compassion (MSC) program, an 8-week workshop, significantly improved self-compassion, mindfulness, and wellbeing in participants, as shown in a pilot study with 21 adults.

In a randomized controlled trial with 25 participants in the treatment group, those who completed the MSC program reported greater increases in self-compassion and wellbeing compared to a waitlist control group, with benefits lasting up to a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study and randomized controlled trial of the mindful self-compassion program. Neff, KD., Germer, CK.[2022]

A 5-week seminar focused on a yoga-inspired biopsychosocial-spiritual model significantly improved self-compassion and mindfulness while reducing anxiety, depression, and stress among 21 graduate healthcare students.

The study highlights the importance of self-care programs in enhancing the well-being and clinical competence of future healthcare providers, suggesting that such interventions can be beneficial in managing stress in high-pressure academic environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 5-Week Seminar on the Biopsychosocial-Spiritual Model of Self-Care Improves Anxiety, Self-Compassion, Mindfulness, Depression, and Stress in Graduate Healthcare Students. Klawonn, A., Kernan, D., Lynskey, J.[2019]

A web-based survey of South Australian yoga participants revealed that practicing yoga more frequently (two or more classes per week) is associated with higher levels of mindfulness and self-compassion, which can help reduce symptoms of depression, anxiety, and stress.

The study highlights the importance of incorporating regular meditation practices and class frequency into yoga interventions aimed at improving mental health outcomes, particularly for anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness, self-compassion, anxiety and depression measures in South Australian yoga participants: implications for designing a yoga intervention. Snaith, N., Schultz, T., Proeve, M., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A naturalistic study of yoga, meditation, self-perceived stress, self-compassion, and mindfulness in college students. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Stress Reduction by Yoga versus Mindfulness Training in Adults Suffering from Distress: A Three-Armed Randomized Controlled Trial including Qualitative Interviews (RELAX Study). [2023]

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

Yoga, meditation, and imagery: clinical applications. [2019]

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

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

'Joining a group was inspiring': a qualitative study of service users' experiences of yoga on social prescription. [2022]

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

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. [2020]

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

Mindfulness and levels of stress: a comparison of beginner and advanced Hatha Yoga practitioners. [2021]

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

How does yoga reduce stress? A clinical trial testing psychological mechanisms. [2023]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

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

Self-compassion in clinical practice. [2013]

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

A pilot study and randomized controlled trial of the mindful self-compassion program. [2022]

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

A 5-Week Seminar on the Biopsychosocial-Spiritual Model of Self-Care Improves Anxiety, Self-Compassion, Mindfulness, Depression, and Stress in Graduate Healthcare Students. [2019]

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

Mindfulness, self-compassion, anxiety and depression measures in South Australian yoga participants: implications for designing a yoga intervention. [2018]