Depressive Symptoms Clinical Trial
Official title:
Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students
NCT number | NCT05447689 |
Other study ID # | 22-02024481 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2023 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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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. — View Citation
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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. — View Citation
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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. — View Citation
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. — View Citation
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.
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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline (week 0) in Depressive symptoms as measured on the Patient Health Questionnaire (PHQ-9) at Weeks 9 and 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 | |
Primary | 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 | |
Primary | 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 | 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). | Week 0, Week 9 and Week 13 |
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