Mind-Body Skills Group for Graduate Students

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05447689
Collaborator
(none)
60
1
2
17
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Integrative-Mind-Body Skills Group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The intervention will be delivered across eight weeks (1 session weekly).The intervention will be delivered across eight weeks (1 session weekly).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Integrative-Mind-Body Skills Group

Treatment group

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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. The Integrative-Mind-Body Skills Group program evaluation measures the acceptability of the Integrative-Mind-Body Skills Group Program. [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.

  2. The Integrative-Mind-Body Skills Group program evaluation measures the feasibility of the Integrative-Mind-Body Skills Group Program. [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.

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. [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).

Other Outcome Measures

  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]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medical College White Plains New York United States 10605

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Patricia Marino, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05447689
Other Study ID Numbers:
  • 22-02024481
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weill Medical College of Cornell University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022