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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an 8-week mind-body skills program can reduce mood symptoms in graduate and medical students. Participants will learn meditation, mindfulness, and relaxation techniques to manage stress and improve quality of life. The trial includes two groups: one will actively participate in the Integrative-Mind-Body Skills Group program, while the other will receive standard resources and reading materials. It is designed for students already in a mental health program who often feel anxious and can attend weekly sessions. As an unphased trial, this study provides a unique opportunity for students to explore innovative stress management techniques that could enhance their mental well-being.

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 prior data suggests that these mind-body skills techniques are safe for mood management?

Research has shown that mind-body skills groups are generally safe and well-tolerated by participants. Studies have found that these groups can help reduce symptoms of posttraumatic stress disorder and depression in young people. Activities like meditation and mindfulness are not only helpful but also safe to practice.

One study found that these techniques effectively reduce stress among medical students. Participants often report feeling more relaxed and less anxious after joining these group activities. No major negative side effects have been reported, indicating a low risk of harm.

While safety remains a priority, the evidence suggests that mind-body skills groups are a safe option for managing mood symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Skills Training for mood symptoms because it offers a holistic approach that combines mental and physical practices, setting it apart from standard treatments like medication and cognitive behavioral therapy. This technique emphasizes integrating mindfulness, relaxation, and self-awareness, potentially enhancing emotional regulation and resilience. By focusing on a person's overall well-being rather than just alleviating symptoms, it could offer a more sustainable and empowering path to managing mood disorders.

What evidence suggests that the Integrative-Mind-Body Skills Group is effective for reducing mood symptoms?

Research shows that mind-body skills groups can help reduce mood problems. Studies have found these methods effective for managing stress and depression, especially during challenging times like the pandemic. For instance, young people have experienced relief from symptoms of posttraumatic stress disorder and depression. Additionally, mind-body practices are linked to a better quality of life by lowering stress and mood-related issues. In this trial, participants in the Integrative-Mind-Body Skills Group will explore these techniques. These findings suggest that the Mind-Body Skills Group could help manage mood symptoms in graduate and medical students. ^{2 4 6 7 8}

Who Is on the Research Team?

Suza C Scalora, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 can attend weekly meetings.

Exclusion Criteria

Active psychosis

I am currently experiencing a manic episode.

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

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Do adolescents consider mind-body skills groups an ... The MBSG treatment has shown to be successful in reducing symptoms of posttraumatic stress disorder [32] and depression for youth [33, 34], including treating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172229/

A Pilot Pre-Post Interventional Study - PMC This study suggests that virtual mind-body practices had a pronounced impact on stress and depression levels during the pandemic. These findings ...

3. clinicaltrial.be clinicaltrial.be/en/details/16201?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Mind-Body Skills Group for Graduate Students - Clinical T... Mind-body approaches have demonstrated effectiveness in reducing stress mood symptoms and improving quality of life. Primary outcomes. 1. The ...

4. researchgate.net researchgate.net/publication/7001417_Mind-Body_Skills_Group_Experience_A_Case_Report

Mind-Body Skills Group Experience: A Case Report ... mood swings, anxiety, and sleep disturbance, as. well as from a number of other unpleasant symptoms, which she. attributed to her medications ...

5. jpedhc.org jpedhc.org/article/S0891-5245(20)30131-0/abstract

Mind-Body Skills Groups for Adolescents With Depression ... The objective of this study was to determine the acceptability and preliminary effectiveness of Mind-Body Skills Groups (MBSGs) as a treatment for depressed ...

6. adaa.trialstoday.org adaa.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDU1NzS1NFLS0bWEAR1jPUNDSxMTQ3MdQ3NjC2MzCwMw0FHKSy4xMDM1NzMwN1OKBQBWmhAf

Anxiety & Depression Association of America Integrative-Mind-Body Skills Group (I-MBS-G) is an 8-week group that teaches skills to build inner resources for effective mood management. This group ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4181427/

Mind-body skills groups for medical students: reducing stress ... The techniques and approach of mind-body medicine and group support have repeatedly demonstrated their effectiveness at reducing stress and ...

8. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/e02a4bda-6ae4-42ab-9d24-d4d0a3f140d7/download

Mind-Body Skills Groups for Adolescents with Depression in Results from our study suggest that MBSGs could be feasible for reducing depression in adolescents seeking mental health treatment in primary care. In addition, ...