- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447689
Mind-Body Skills Group for Graduate Students
Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suza C Scalora, PhD
- Phone Number: 917-209-5311
- Email: sus9128@med.cornell.edu
Study Contact Backup
- Name: Patricia Marino, PhD
- Phone Number: 914-997-8691
- Email: pam2029@med.cornell.edu
Study Locations
-
-
New York
-
White Plains, New York, United States, 10605
- Recruiting
- Weill Cornell Medical College
-
Contact:
- Patricia Marino, PhD
- Phone Number: 914-997-8691
- Email: pam2029@med.cornell.edu
-
Principal Investigator:
- Suza C. Scalora, PhD
-
Contact:
- Suza C Scalora, PhD
- Phone Number: 9172095311
- Email: sus9128@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrative-Mind-Body Skills Group
Treatment 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.
|
|
No Intervention: Control
Control group: Treatment-As-Usual (TAU) and mind-body skills reading materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
Time Frame: Week 9
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
|
Week 0, Week 9 and Week 13
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline (week 0) in Depressive symptoms as measured on the Patient Health Questionnaire (PHQ-9) at Weeks 9 and 13.
Time Frame: Week 0, Week 9 and Week 13
|
The Patient Health Questionnaire (PHQ-9) is a validated, self-report instrument assessing the severity of depressive symptoms across the previous two weeks.
Score range: 0-27; minimal depression 0-4; mild depression 5-9; moderate depression 10-14; Moderately severe depression 15-10; Severe depression 20-27.
Change = (Week 13 score - Week 0 score).
Change = (Week 9 score - Week 0 score).
|
Week 0, Week 9 and Week 13
|
Collaborators and Investigators
Investigators
- Principal Investigator: Suza C Scalora, PhD, Weill Medical College of Cornell University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-02024481
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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