Mind-Body Skills Training for Mood Symptoms

Overseen By Patricia Marino, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Active SI, Current mania, Active psychosis

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program that teaches meditation, mindfulness, and relaxation techniques to help medical graduate students manage stress and improve their mood.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on teaching skills for mood management, so you may not need to change your medication routine.

What data supports the effectiveness of the treatment Integrative-Mind-Body Skills Group for mood symptoms?

Research shows that mind-body interventions can help reduce depressive symptoms in older adults and improve quality of life through activities like mindfulness meditation and guided imagery, which are components of the Integrative-Mind-Body Skills Group. ^{1 2 3 4 5}

Is mind-body skills training safe for humans?

Mind-body skills training is generally considered safe for humans, as it is widely used and integrated into clinical practice for various conditions, with research supporting its safety and benefits for mental and physical health. ^{4 6 7 8 9}

How is the Integrative-Mind-Body Skills Group treatment different from other treatments for mood symptoms?

The Integrative-Mind-Body Skills Group treatment is unique because it combines mind-body techniques to address mood symptoms, focusing on stress management and improving overall well-being, rather than just targeting specific symptoms like traditional therapies. This approach is holistic, aiming to enhance both mental and physical health through practices such as mindfulness and relaxation. ^{4 10 11 12 13}

Research Team

Suza C Scalora, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for graduate and medical students aged 18 or older who are experiencing mood symptoms like anxiety or depression. Participants must be able to attend weekly sessions and have a score of ≥4 on the Generalized Anxiety Disorder scale. Those with active suicidal thoughts, current mania, or psychosis cannot join.

Inclusion Criteria

Students screened and admitted to the Student Mental Health Program

A score of ≥ 4 on the Generalized Anxiety Disorder scale (GAD-7)

I am 18 years old or older.

Exclusion Criteria

Active psychosis

I am currently experiencing a manic episode.

I am currently having thoughts about harming myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week Integrative-Mind-Body Skills Group (I-MBS-G) to learn skills for mood management

8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in depressive and anxiety symptoms after the intervention

5 weeks

Assessments at Week 9 and Week 13

Treatment Details

Interventions

• Integrative-Mind-Body Skills Group

Trial Overview The study tests an 8-week Integrative-Mind-Body Skills Group (I-MBS-G) program designed to improve mood management through meditation, mindfulness, guided imagery, breath work, body awareness, and relaxation techniques.

Participant Groups

Group I: Integrative-Mind-Body Skills Group Experimental Treatment 1 Intervention

Treatment group

Group II: Control Active Control 1 Intervention

Control group: Treatment-As-Usual (TAU) and mind-body skills reading materials.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

Participants in a self-development course using mind-body medicine (MBM) activities showed significant improvements in quality of life across eight health-related quality of life (HRQOL) subscales, including emotional well-being and cognitive functioning, six months after the intervention.

The sense of coherence (SOC) also improved significantly in participants, suggesting that the course effectively enhanced their overall health perception and resilience, challenging previous beliefs about the stability of SOC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of life using compound mind-body therapies: evaluation of a course intervention with body movement and breath therapy, guided imagery, chakra experiencing and mindfulness meditation. Fernros, L., Furhoff, AK., Wändell, PE.[2021]

Mind-body interventions significantly reduced depressive symptoms in older Chinese adults, showing a large short-term effect size of -1.41 based on a systematic review of 14 randomized controlled trials.

Most studies did not evaluate the long-term effects of these interventions, indicating a need for further research to understand their lasting impact on depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mind-body interventions on depressive symptoms among older Chinese adults: a systematic review and meta-analysis. Bo, A., Mao, W., Lindsey, MA.[2018]

A pilot study involving 52 participants with chronic health conditions showed that mind-body medicine (MBM) interventions led to significant improvements in mental health, particularly in depression scores (PHQ-9) with a large effect size (g=0.807).

The MBM collaborative visits not only improved participants' ability to cope with stress and their sense of control over their health but also provided a valuable training experience for medical learners, enhancing their professional satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do as I Do: Physician- and Learner-Led Mind-Body Medicine Group Visits. Moir, E., Yang, JO., Yao, J., et al.[2022]

Online mind-body skills (MBS) training significantly improved clinicians' and trainees' stress levels, mindfulness, and confidence in providing compassionate care after 12 weeks, compared to those who did not participate.

The study involved 103 participants (60 in MBS training and 43 in a control group) and demonstrated that even with a median engagement of only 3 out of 12 modules, MBS training was effective, suggesting that online training can be a practical alternative to in-person sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Impact of Online Training in Mind-Body Skills? Kemper, KJ., Lynn, J., Mahan, JD.[2022]

A psychosomatic treatment model involving over 300 patients emphasizes the importance of social reinforcement and self-control, leading to improved pain tolerance and reduced drug use when care-giving responses are minimized.

One-year follow-up results indicate that most patients achieved their self-set goals, with those returning to supportive family environments experiencing continued decreases in somatic complaints and increased motivation for achievement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A learning theory model of chronic illness behavior: theory, treatment, and research. Wooley, SC., Blackwell, B., Winget, C.[2019]

The paper highlights the importance of bidirectional interactions between the brain and peripheral systems, such as cardiovascular and immune systems, in influencing both mental and physical health, suggesting that therapies targeting these connections may effectively treat chronic disease symptoms.

It proposes a psychophysiological framework that emphasizes the role of specific brain regions and pathways in integrating mind-body interactions, with heart rate variability and inflammation markers serving as key indicators of this integration and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top-down and bottom-up mechanisms in mind-body medicine: development of an integrative framework for psychophysiological research. Taylor, AG., Goehler, LE., Galper, DI., et al.[2022]

A 10-week mind-body medicine program significantly reduced persistent fatigue in 68 breast cancer survivors, with fatigue scores improving by 40% after the intervention and sustained improvements observed at two and six months post-program.

The program demonstrated effectiveness in enhancing fatigue levels as measured by multiple scales, suggesting that holistic approaches can be beneficial for breast cancer survivors dealing with fatigue, warranting further investigation through randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in breast cancer survivors: the impact of a mind-body medicine intervention. Appling, SE., Scarvalone, S., MacDonald, R., et al.[2013]

A survey of 74 physicians revealed that while there is a high interest in mind-body medicine (MBM) techniques like relaxation and meditation, barriers such as lack of training and clinic time hinder their adoption in practice.

Female physicians showed a greater likelihood of using MBM therapies and had stronger beliefs in their benefits for health disorders compared to their male counterparts, indicating a potential gender difference in the acceptance of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mind-body therapies in psychiatry and family medicine faculty and residents: attitudes, barriers, and gender differences. Sierpina, V., Levine, R., Astin, J., et al.[2018]

Mind-body therapies (MBTs) have been shown to influence health outcomes by modulating immune function and inflammation, as evidenced by changes in gene transcription factors and sympathetic nervous system activation.

Research using neuroimaging and functional genomics indicates that MBTs can lead to persistent changes in brain function and structure, which are important for attention, learning, and emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The embodied mind: A review on functional genomic and neurological correlates of mind-body therapies. Muehsam, D., Lutgendorf, S., Mills, PJ., et al.[2019]

In a study of 126 adults with mild to moderate depression and sleep disturbances, a mind-body-spirit intervention (I-BMS) showed that improvements in depressive symptoms partially mediated better sleep at night and fully mediated improvements in daytime insomnia symptoms.

The intervention's impact on mood was significantly influenced by daytime insomnia and spiritual orientation, highlighting the importance of addressing both sleep and spiritual well-being in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interrelationship between sleep and depression: a secondary analysis of a randomized controlled trial on mind-body-spirit intervention. Ji, XW., Chan, CH., Lau, BH., et al.[2022]

The Multidimensional Assessment of Interoceptive Awareness (MAIA) was successfully translated into Chinese (MAIA-C) and demonstrated strong overall reliability (Cronbach's α = .91) and acceptable validity for assessing interoceptive awareness in Chinese-speaking individuals engaged in mind-body practices.

The MAIA-C confirmed its eight-factor structure through psychometric testing with 294 participants, showing significant differences in interoceptive awareness between highly experienced and less experienced practitioners, indicating its effectiveness in evaluating the impact of mind-body interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation and Psychometric Testing of the Chinese Version of the Multidimensional Assessment of Interoceptive Awareness. Lin, FL., Hsu, CC., Mehling, W., et al.[2022]

The Mind-Body Medicine program, involving 239 active duty service members and veterans over 7 weeks, showed significant improvements in perceived stress, pain severity, and various psychological symptoms, indicating its effectiveness in enhancing mental and physical health.

Participants reported high satisfaction with the program, and both groups (those with high stress and those with chronic pain) experienced notable benefits, suggesting that mind-body interventions can be valuable in military healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mind-body program for pain and stress management in active duty service members and veterans. Millegan, J., Denninger, JW., Bui, E., et al.[2021]

A study involving 24 economically disadvantaged individuals with HIV revealed that progressive muscle relaxation training and guided imagery (PMRT-GI) effectively reduced stress and anxiety, highlighting its potential as a therapeutic intervention.

Participants identified five key themes that contributed to the effectiveness of PMRT-GI: a sense of escape ('another world'), feelings of contentment, reduced muscle tension, personalized attention ('one-on-one'), and the calming effect of soft music, indicating the importance of cultural acceptability in therapy design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lived experience of a mind-body intervention for people living with HIV. Andrade, SK., Anderson, EH.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Improving quality of life using compound mind-body therapies: evaluation of a course intervention with body movement and breath therapy, guided imagery, chakra experiencing and mindfulness meditation. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Effects of mind-body interventions on depressive symptoms among older Chinese adults: a systematic review and meta-analysis. [2018]

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

Do as I Do: Physician- and Learner-Led Mind-Body Medicine Group Visits. [2022]

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

What Is the Impact of Online Training in Mind-Body Skills? [2022]

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

A learning theory model of chronic illness behavior: theory, treatment, and research. [2019]

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

Top-down and bottom-up mechanisms in mind-body medicine: development of an integrative framework for psychophysiological research. [2022]

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

Fatigue in breast cancer survivors: the impact of a mind-body medicine intervention. [2013]

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

Use of mind-body therapies in psychiatry and family medicine faculty and residents: attitudes, barriers, and gender differences. [2018]

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

The embodied mind: A review on functional genomic and neurological correlates of mind-body therapies. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The interrelationship between sleep and depression: a secondary analysis of a randomized controlled trial on mind-body-spirit intervention. [2022]

11. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Translation and Psychometric Testing of the Chinese Version of the Multidimensional Assessment of Interoceptive Awareness. [2022]

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

A mind-body program for pain and stress management in active duty service members and veterans. [2021]

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

The lived experience of a mind-body intervention for people living with HIV. [2019]