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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a special program combining integrative Hatha yoga and mindful self-compassion can reduce stress in women who have experienced interpersonal violence. Participants will engage in a 12-week program designed to promote healing and emotional well-being. Women who have experienced interpersonal violence, feel distressed, and have access to a telephone and a device for video sessions may be well-suited for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance emotional well-being for women in similar situations.

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 prior data suggests that this program is safe for women survivors of interpersonal violence?

Research shows that both yoga and mindfulness meditation can reduce stress by boosting self-kindness, which helps people manage stress better. Studies have found that participants in yoga programs often feel less stressed and more positive overall.

Mindfulness and self-kindness also correlate with lower levels of depression and anxiety, meaning practitioners often feel less sad and worried. A mindful self-kindness program has demonstrated effectiveness in reducing self-criticism, particularly in those with anxiety or depression.

Overall, these practices are generally well-tolerated, with most people not experiencing negative side effects. Instead, they often notice improvements in mental well-being, such as feeling calmer and more at ease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Integrative Hatha Yoga and Mindful Self-Compassion for stress because these practices offer a holistic approach that differs from typical treatments like medication and cognitive-behavioral therapy. This treatment combines physical yoga movements with self-compassion exercises, aiming to promote both mental and physical well-being, which is particularly beneficial for women who have experienced interpersonal violence. Unlike standard treatments that often focus solely on psychological aspects, this approach encourages a more comprehensive healing process by integrating mind-body practices.

What evidence suggests that this program is effective for stress in women survivors of interpersonal violence?

Research has shown that both yoga and mindfulness meditation can reduce stress by increasing self-kindness. Self-kindness strongly indicates stress reduction. One study found that Hatha yoga classes improved symptoms of depression, anxiety, and stress. Additionally, Mindfulness-Based Stress Reduction (MBSR) has lowered anxiety, depression, and stress while increasing mindfulness and self-kindness. This trial will evaluate the Integrative Hatha Yoga and Mindful Self-Compassion Program, which may effectively reduce stress for participants. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

Have access to a device that will support use of the video platform used for assessments and home practice yoga video sessions

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

Citations

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Yoga and Self-Compassion for Stress (I-YMSC Trial)

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We hypothesized that the yoga classes, but not the educational workshop, would lead to improvements in depression, anxiety, stress, emotion dysregulation, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7511255/

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MBSR reduces anxiety, depression, and stress, and increases mindfulness and self-compassion in HCPs, but is less effective in reducing burnout.

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MBSR intervention was effective at improving, and maintaining, mindfulness and self-compassion levels and to improve burnout, depression, anxiety, stress. The ...

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researchgate.net

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A Randomized Control Trial of the Effects of a Hatha Yoga ...

Results indicated that those in the yoga program, but not in the education program, showed significant improvement on measures of stress, ...

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sciencedirect.com

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Mindfulness, self-compassion, anxiety and depression ...

Results showed a positive correlation with mindfulness and self-compassion and negative correlation with Depression, Anxiety and Stress scores with months ...

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chacmc.org/publications

Center for Mindfulness & Compassion - Boston

This pilot study examined how an eight-week mindful self-compassion (MSC) program helps reduce self-judgment in people with anxiety or depression. ... This study ...