48 Participants Needed

Yoga and Mindfulness for Psychological Distress

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Butler Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Integrative Yoga & Mindful Self-Compassion training can assist women distressed by interpersonal violence. Researchers aim to determine if these practices are more effective than general wellbeing education. Participants will join either a 12-week yoga and mindfulness program or a group focused on women's wellbeing. Women who have experienced violence and feel distressed may be suitable candidates if they are comfortable using video calls for activities. As an unphased trial, this study provides a unique opportunity for women to explore innovative practices that may enhance their emotional wellbeing.

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 have not been stable for the last 8 weeks, you may not be eligible to participate.

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

Research shows that Integrative Yoga & Mindful Self-Compassion training is generally safe and well-tolerated. Reviews of similar programs suggest these practices can boost mindfulness and mental well-being without causing serious side effects. Another study found that people practicing mindfulness and self-compassion reported feeling less depressed, anxious, and stressed.

Past trials did not link these programs to major negative effects, indicating that participants usually handle the treatment well. These findings help reassure those considering joining the trial about its safety.12345

Why are researchers excited about this trial?

Researchers are excited about Integrative Yoga and Mindful Self-Compassion (I-YMSC) training because it offers a holistic approach to managing psychological distress, which is different from traditional methods like medication and talk therapy. Unlike standard treatments that often focus on symptoms, I-YMSC combines physical movement, mindfulness, and self-compassion to potentially address the root causes of distress. This approach aims to empower individuals with tools to manage stress and emotions more effectively, which could lead to long-lasting benefits without the side effects commonly associated with medications. Additionally, the practice of self-compassion in particular is gaining attention for its potential to enhance emotional resilience and well-being.

What evidence suggests that this trial's treatments could be effective for psychological distress?

Research has shown that practicing mindfulness and self-compassion can greatly reduce negative feelings and compassion fatigue. Studies indicate that regularly engaging in yoga and mindfulness exercises increases self-compassion, which is linked to lower levels of depression, anxiety, and stress. Participants often report feeling less upset over time. One study found that yoga improves mindfulness and self-compassion. This trial will compare two approaches: Integrative Yoga and Mindful Self-Compassion (I-YMSC) training and Women's Wellbeing Education (WWE). Overall, evidence suggests that I-YMSC training can help reduce psychological distress, making it a promising option for those who have experienced interpersonal violence.12567

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-65 who have experienced interpersonal violence and are feeling distressed. They must have access to a device for video sessions, a telephone, and not be pregnant or suffering from certain mental health conditions like current mania or severe substance use disorder.

Inclusion Criteria

Speak and understand English well enough to understand questionnaires when read aloud
Have access to a device that will support use of the video platform used for assessments and home practice yoga video sessions
Report having experienced interpersonal violence confirmed with the Trauma History Questionnaire (THQ)
See 3 more

Exclusion Criteria

Pregnancy
Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Lifetime history of psychotic disorders (DIAMOND)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of integrative yoga and mindful self-compassion training or women's wellbeing education

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Integrative Yoga & Mindful Self-Compassion training
  • Women's Wellbeing Education
Trial Overview The study compares an integrative yoga and mindful self-compassion program with a women's wellbeing education program to see which is better at reducing psychological distress in women with a history of interpersonal violence.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrative Yoga and Mindful Self-Compassion (I-YMSC) trainingExperimental Treatment1 Intervention
Group II: Women's Wellbeing Education (WWE)Active Control1 Intervention

Find a Clinic Near You

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+

Citations

Mindfulness, Compassion, and Self-Compassion Among ...Mindfulness was effective at improving negative affect and compassion fatigue, while compassion satisfaction may be related to cultivation of positive affect.
The Impact of Yoga and Mindfulness-Based Practices on ...Quantitative results show that self-compassion and practice frequency are strongly positively correlated, with practice frequency significantly ...
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 ...
Effectiveness of mindful self-compassion therapy on ...On par with these adverse effects, it is found that psychological distress among these patients is significantly associated with marital instability [9].
The effect of the yoga course on mindfulness and self‐ ...Purpose. This study aimed to investigate the effect of yoga on mindfulness and self-compassion among nursing students.
Yoga and Mindfulness for Psychological DistressThis N/A medical study run by Butler Hospital is evaluating whether Integrative Yoga & Mindful Self-Compassion training will have tolerable side effects ...
A Brief Online Program Integrating Mindfulness and ...The experimental group showed statistically significant improvements in mindfulness, self-compassion, and mental well-being compared with the ...
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