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NCT Number: NCT05447689

Mind-Body Skills Group for Graduate Students

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.

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Key information

Conditions

Mood Change Anxiety Disorders Anxiety Generalized Behavior Behavioral Symptoms Depression Depressive Symptoms Generalized Anxiety Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative-Mind-Body Skills Group

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Marino, PhD

CONTACT

[email protected]

914-997-8691

Suza C Scalora, PhD

CONTACT

[email protected]

917-209-5311

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Integrative-Mind-Body Skills Group for Mood Management Among Medical Graduate Students

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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