NCT05447689

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2023Jun 2027

First Submitted

Initial submission to the registry

June 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

June 29, 2022

Last Update Submit

January 22, 2026

Conditions

Keywords

Mind-Body Skills Group InterventionGraduate student mental healthMedical student mental health

Outcome Measures

Primary Outcomes (2)

  • 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.

    Week 9

  • 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.

    Week 9

Secondary Outcomes (1)

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

    Week 0, Week 9 and Week 13

Other Outcomes (1)

  • Change from Baseline (week 0) in Depressive symptoms as measured on the Patient Health Questionnaire (PHQ-9) at Weeks 9 and 13.

    Week 0, Week 9 and Week 13

Study Arms (2)

Integrative-Mind-Body Skills Group

EXPERIMENTAL

Treatment group

Behavioral: Integrative-Mind-Body Skills Group

Control

NO INTERVENTION

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

Interventions

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.

Integrative-Mind-Body Skills Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active SI
  • Current mania
  • Active psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

White Plains, New York, 10605, United States

RECRUITING

Related Publications (15)

  • 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: 34355345BACKGROUND
  • 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: 27286249BACKGROUND
  • 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: 27923088BACKGROUND
  • 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: 19077856BACKGROUND
  • 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: 19174678BACKGROUND
  • 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: 17120398BACKGROUND
  • 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: 16565189BACKGROUND
  • 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: 18765703BACKGROUND
  • 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.

    PMID: 17538833BACKGROUND
  • 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.

    PMID: 25245341BACKGROUND
  • 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.

    PMID: 30081886BACKGROUND
  • 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.

    PMID: 21920596BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23596092BACKGROUND

MeSH Terms

Conditions

DepressionGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAnxiety DisordersMental Disorders

Study Officials

  • Suza C Scalora, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suza C Scalora, PhD

CONTACT

Patricia Marino, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention will be delivered across eight weeks (1 session weekly).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 7, 2022

Study Start

April 3, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations