Mind-Body Skills Group for Graduate Students

Not Applicable

Recruiting

• Conditions: Mood Change; Depressive Symptoms; Anxiety Generalized
• Interventions: Behavioral: Integrative-Mind-Body Skills Group

• Registration Number: NCT05447689
• Lead Sponsor: Weill Medical College of Cornell University

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)

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-07
• Study Start: 2023-04-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrative-Mind-Body Skills Group	Integrative-Mind-Body Skills Group	Treatment group

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 White Plains, New York, United States