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Recruiting NCT05447689

Mind-Body Skills Group for Graduate Students

No phase Interventional Mood Change Depressive Symptoms Anxiety Generalized

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrative-Mind-Body Skills Group.
Who it may be relevant to
Registry conditions: Mood Change, Depressive Symptoms, Anxiety Generalized. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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)

Interventions

  • Behavioral Integrative-Mind-Body Skills Group
    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.

Primary outcome measures

  • The Integrative-Mind-Body Skills Group program evaluation measures the acceptability of the Integrative-Mind-Body Skills Group Program. [Time frame: Week 9]
  • The Integrative-Mind-Body Skills Group program evaluation measures the feasibility of the Integrative-Mind-Body Skills Group Program. [Time frame: Week 9]
Secondary outcome measures (1)
  • Change from Baseline (week 0) in Anxiety symptoms as measured in the Generalized Anxiety Disorder (GAD-7) at Weeks 9 and 13. [Time frame: Week 0, Week 9 and Week 13]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Active SI
  • Current mania
  • Active psychosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medical College — White Plains

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 18765703

Identifiers

NCT: NCT05447689 · 22-02024481

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗