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Mind-Body Skills Group for Graduate Students

Primary Purpose

Mood Change, Depressive Symptoms, Anxiety Generalized

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrative-Mind-Body Skills Group
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Change focused on measuring Mind-Body Skills Group Intervention, Graduate student mental health, Medical student mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weill Cornell Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrative-Mind-Body Skills Group

Control

Arm Description

Treatment group

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 29, 2022
Last Updated
April 12, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05447689
Brief Title
Mind-Body Skills Group for Graduate Students
Official Title
Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Change, Depressive Symptoms, Anxiety Generalized
Keywords
Mind-Body Skills Group Intervention, Graduate student mental health, Medical student mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will be delivered across eight weeks (1 session weekly).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrative-Mind-Body Skills Group
Arm Type
Experimental
Arm Description
Treatment group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group: Treatment-As-Usual (TAU) and mind-body skills reading materials.
Intervention Type
Behavioral
Intervention Name(s)
Integrative-Mind-Body Skills Group
Intervention Description
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 Measure Information:
Title
The Integrative-Mind-Body Skills Group program evaluation measures the acceptability of the Integrative-Mind-Body Skills Group Program.
Description
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.
Time Frame
Week 9
Title
The Integrative-Mind-Body Skills Group program evaluation measures the feasibility of the Integrative-Mind-Body Skills Group Program.
Description
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.
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Change from Baseline (week 0) in Anxiety symptoms as measured in the Generalized Anxiety Disorder (GAD-7) at Weeks 9 and 13.
Description
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).
Time Frame
Week 0, Week 9 and Week 13
Other Pre-specified Outcome Measures:
Title
Change from Baseline (week 0) in Depressive symptoms as measured on the Patient Health Questionnaire (PHQ-9) at Weeks 9 and 13.
Description
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).
Time Frame
Week 0, Week 9 and Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suza C Scalora, PhD
Phone
917-209-5311
Email
sus9128@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Marino, PhD
Phone
914-997-8691
Email
pam2029@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Marino, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suza C Scalora, PhD
Phone
917-209-5311
Email
sus9128@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Patricia Marino, PhD
Phone
914-997-8691
Email
pam2029@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Patricia Marino, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34355345
Citation
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.
Results Reference
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PubMed Identifier
27286249
Citation
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.
Results Reference
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PubMed Identifier
27923088
Citation
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.
Results Reference
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PubMed Identifier
19077856
Citation
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PubMed Identifier
19174678
Citation
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PubMed Identifier
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Citation
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.
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PubMed Identifier
16565189
Citation
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.
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PubMed Identifier
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PubMed Identifier
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Citation
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Citation
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Citation
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Mind-Body Skills Group for Graduate Students

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