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Mood ChangeNCT05447689

Mind-Body Skills Group for Graduate Students

A study testing Integrative-Mind-Body Skills Group in people with Mood Change and Depressive Symptoms, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 incorporates a holistic approach to wellness through meditation and mindfulness practices, guided imagery, breath and body awareness, and relaxation techniques. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Integrative-Mind-Body Skills Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
3 Apr 2023to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Students screened and admitted to the Student Mental Health Program.
  • Age 18 or older
  • A score of ≥ 4 on the Generalized Anxiety Disorder scale (GAD-7)
  • Able to attend weekly meeting times

Who cannot join

  • Active SI
  • Current mania
  • Active psychosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suza C Scalora, PhD contact

917-209-5311

sus9128@med.cornell.edu

Patricia Marino, PhD contact

914-997-8691

pam2029@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medical College

    White Plains, New York, 10605

    Suza C Scalora, PhD, 9172095311, sus9128@med.cornell.edu

    Patricia Marino, PhD, 914-997-8691, pam2029@med.cornell.edu

    Recruiting

Other trials in United States

About this study

Official title: Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students

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 incorporates a holistic approach to wellness through meditation and mindfulness practices, guided imagery, breath and body awareness, and relaxation techniques. Mind-body approaches have demonstrated effectiveness in reducing stress mood symptoms and improving quality of life. The study hypothesis is that the Mind-Body Skills taught in the group will reduce mood symptoms in graduate and medical students.

Read the detailed description

Study Design: This study will identify medical graduate students interested in participating in an Integrative-Mind-Body Skills Group (I-MBS-G) to strengthen inner resources to effectively navigate complex and stressful daily events to promote mental and physical health and well-being. This study is a pilot randomized controlled trial; participants will be randomized to the intervention or control group. The control group will receive Treatment-As-Usual (TAU) and mind-body skills reading materials.

Primary Objective: Assess the feasibility and acceptability of an I-MBS-G intervention for medical graduate students using the MBSG Feedback Program Questionnaire.

Secondary Objectives: Assess preliminary effectiveness of I-MBS-G on anxiety symptoms (i.e., improvements on anxiety symptoms)

Exploratory Objectives: Assess preliminary effectiveness of I-MBS-G on depression symptoms (i.e., improvements on depression symptoms)

Being tested
Integrative-Mind-Body Skills Group
Keywords
Mind-Body Skills Group Intervention, Graduate student mental health, Medical student mental health
Medical subject headings
Depression, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative-Mind-Body Skills GroupBehavioural

    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 incorporates a holistic approach to wellness through meditation and mindfulness practices, guided imagery, breath and body awareness, relaxation techniques, self-reflection, and mindfulness-based cognitive-behavioral skills. Mind-body approaches have demonstrated effectiveness in reducing stress mood symptoms and improving quality of life.

Study groups in NCT05447689
Study groupRoleWhat they receive
Integrative-Mind-Body Skills GroupExperimentalTreatment group
Receives: Behavioral: Integrative-Mind-Body Skills Group
ControlNo interventionControl group: Treatment-As-Usual (TAU) and mind-body skills reading materials.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Integrative-Mind-Body Skills Group program evaluation measures the acceptability of the Integrative-Mind-Body Skills Group Program.

    The Integrative-Mind-Body Skills Group program evaluation is a quantitative self-report survey assessing the acceptability of the Integrative-Mind-Body Skills Group measured at Week 9. The Integrative-Mind-Body Skills Group evaluation uses three items measured on a 5-point Likert scale and one item measured on a 3-point Likert scale. Score range: 4- 18; acceptability = a sum score of 14 or greater; unacceptability = a sum score of 4.

    Measured: Week 9

  2. The Integrative-Mind-Body Skills Group program evaluation measures the feasibility of the Integrative-Mind-Body Skills Group Program.

    The Integrative-Mind-Body Skills Group program evaluation is a quantitative self-report survey assessing the feasibility of the Integrative-Mind-Body Skills Group measured at Week 9. To evaluate the feasibility of the Integrative-Mind-Body Skills Group, the number of sessions attended is measured by one item. There are eight sessions in the program. Score range: 1- 8; feasibility = score of 5 sessions or greater.

    Measured: Week 9

Secondary outcomes (1)

  1. Change from Baseline (week 0) in Anxiety symptoms as measured in the Generalized Anxiety Disorder (GAD-7) at Weeks 9 and 13.

    The Generalized Anxiety Disorder scale is a validated, self-report instrument assessing the severity of anxiety symptoms across the previous two weeks. Score range: 0-21; minimal anxiety 0-4; mild anxiety 5-9; moderate 10-14; Moderately severe depression 15-10; Severe anxiety - a score greater than 15. Change = (Week 13 score - Week 0 score). Change = (Week 9 score - Week 0 score).

    Measured: Week 0, Week 9 and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start3 Apr 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention will be delivered across eight weeks (1 session weekly).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447689
Sponsor's protocol ID
22-02024481
Status last verified
Jan 2026
First submitted
29 Jun 2022
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Christophers B, Nieblas-Bedolla E, Gordon-Elliott JS, Kang Y, Holcomb K, Frey MK. Mental Health of US Medical Students During the COVID-19 Pandemic. J Gen Intern Med. 2021 Oct;36(10):3295-3297. doi: 10.1007/s11606-021-07059-y. Epub 2021 Aug 5. No abstract available.

    PubMed 34355345

  • Mousa OY, Dhamoon MS, Lander S, Dhamoon AS. The MD Blues: Under-Recognized Depression and Anxiety in Medical Trainees. PLoS One. 2016 Jun 10;11(6):e0156554. doi: 10.1371/journal.pone.0156554. eCollection 2016.

    PubMed 27286249

  • Rotenstein LS, Ramos MA, Torre M, Segal JB, Peluso MJ, Guille C, Sen S, Mata DA. Prevalence of Depression, Depressive Symptoms, and Suicidal Ideation Among Medical Students: A Systematic Review and Meta-Analysis. JAMA. 2016 Dec 6;316(21):2214-2236. doi: 10.1001/jama.2016.17324.

    PubMed 27923088

  • Compton MT, Carrera J, Frank E. Stress and depressive symptoms/dysphoria among US medical students: results from a large, nationally representative survey. J Nerv Ment Dis. 2008 Dec;196(12):891-7. doi: 10.1097/NMD.0b013e3181924d03.

    PubMed 19077856

  • Goebert D, Thompson D, Takeshita J, Beach C, Bryson P, Ephgrave K, Kent A, Kunkel M, Schechter J, Tate J. Depressive symptoms in medical students and residents: a multischool study. Acad Med. 2009 Feb;84(2):236-41. doi: 10.1097/ACM.0b013e31819391bb.

    PubMed 19174678

  • Dyrbye LN, Thomas MR, Huschka MM, Lawson KL, Novotny PJ, Sloan JA, Shanafelt TD. A multicenter study of burnout, depression, and quality of life in minority and nonminority US medical students. Mayo Clin Proc. 2006 Nov;81(11):1435-42. doi: 10.4065/81.11.1435.

    PubMed 17120398

  • Dyrbye LN, Thomas MR, Huntington JL, Lawson KL, Novotny PJ, Sloan JA, Shanafelt TD. Personal life events and medical student burnout: a multicenter study. Acad Med. 2006 Apr;81(4):374-84. doi: 10.1097/00001888-200604000-00010.

    PubMed 16565189

  • Dyrbye LN, Thomas MR, Massie FS, Power DV, Eacker A, Harper W, Durning S, Moutier C, Szydlo DW, Novotny PJ, Sloan JA, Shanafelt TD. Burnout and suicidal ideation among U.S. medical students. Ann Intern Med. 2008 Sep 2;149(5):334-41. doi: 10.7326/0003-4819-149-5-200809020-00008.

    PubMed 18765703

  • Dahlin M, Joneborg N, Runeson B. Performance-based self-esteem and burnout in a cross-sectional study of medical students. Med Teach. 2007 Feb;29(1):43-8. doi: 10.1080/01421590601175309.

    PubMed 17538833

  • Gordon JS. Mind-body skills groups for medical students: reducing stress, enhancing commitment, and promoting patient-centered care. BMC Med Educ. 2014 Sep 22;14:198. doi: 10.1186/1472-6920-14-198.

    PubMed 25245341

  • Ayala EE, Winseman JS, Johnsen RD, Mason HRC. U.S. medical students who engage in self-care report less stress and higher quality of life. BMC Med Educ. 2018 Aug 6;18(1):189. doi: 10.1186/s12909-018-1296-x.

    PubMed 30081886

  • Yonker JE, Schnabelrauch CA, Dehaan LG. The relationship between spirituality and religiosity on psychological outcomes in adolescents and emerging adults: a meta-analytic review. J Adolesc. 2012 Apr;35(2):299-314. doi: 10.1016/j.adolescence.2011.08.010. Epub 2011 Sep 14.

    PubMed 21920596

  • Yotter, C. N., & Swank, M. (2017). The impact of spirituality and stress on the health of emerging adults. SUURJ: Seattle University Undergraduate Research Journal, 1(1), 17.

  • Liu, C., Beauchemin, J., Wang, X., & Lee, M. Y. (2018). Integrative body-mind-spirit (I-BMS) interventions for posttraumatic stress disorder (PTSD): A review of the outcome literature. Journal of Social Service Research, 44(4), 482-493.

  • King AP, Erickson TM, Giardino ND, Favorite T, Rauch SA, Robinson E, Kulkarni M, Liberzon I. A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). Depress Anxiety. 2013 Jul;30(7):638-45. doi: 10.1002/da.22104. Epub 2013 Apr 17.

    PubMed 23596092

Questions about this trial

What is this clinical trial studying?

A study testing Integrative-Mind-Body Skills Group in people with Mood Change and Depressive Symptoms, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suza C Scalora, PhD (917-209-5311, sus9128@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Integrative-Mind-Body Skills Group program evaluation measures the acceptability of the Integrative-Mind-Body Skills Group Program. (time frame: Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05447689, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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