NCT06866288

Brief Summary

The long-term goal of this study is to develop a mindfulness-based intervention (MBI) program to reduce stress and burnout while increasing belongingness and connectedness among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON). The central hypothesis is that the MBI intervention will improve psychosocial outcomes (sense of belonging) and physiological outcomes (heart rate variability, HRV) among CON faculty and staff. The specific aims are to: Aim 1: Evaluate the feasibility and acceptability of MBIs (meditation or yoga) through participant interviews, recruitment, retention, and adherence rates. Aim 2: Assess the preliminary effects of MBIs on psychosocial (burnout, stress, anxiety, sense of belonging) and physiological (HRV) outcomes. The hypothesis predicts improvements in both psychosocial and physiological measures post-intervention. Researchers will compare meditation to yoga to see if one improves psychosocial and physiological outcomes better that the other. Participants will be asked to:

  • participate in meditation or yoga two times per week
  • complete surveys
  • use an app on their phone to answer short surveys
  • wear a smart device

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

March 4, 2025

Last Update Submit

November 5, 2025

Conditions

Keywords

Mindfulness based interventionsmeditationyogaheart rate variability

Outcome Measures

Primary Outcomes (2)

  • Belongingness

    Belonging will be assessed using the 8-item Sense of Belonging Scale (SBS). The SBS measures the sense of belongingness or feelings of acceptance and inclusion in a community experienced by an individual.21 The SBS was developed to be adapted to specific contexts.21 Using the method described by Mellinger and Park (2023), we adapted the scale to be specific to UNM CON faculty and staff. Response categories range from 1 (Strongly disagree) to 5 (strongly agree). Responses are summed and the mean is calculated with higher scores corresponding to a stronger sense of belonging.22 The SBS-8 demonstrated high levels of reliability with a Cronbach's alpha coefficient of .96.21

    Baseline and 6 weeks

  • Burnout

    Assessment of burnout: The Copenhagen Burnout Inventory is a valid and reliable, 19- item, self-report measure of burnout.24 Originally designed to measure burnout in among human service workers, it includes 3 scales. The personal burnout scale has six items and measures prolonged physical and emotional exhaustion. The work-related burnout scale has seven items that measure prolonged physical and emotional exhaustion secondary to work. The third scale, client-related burnout, has six items that measure burnout related to working with clients (client may be patients, students, service recipients). Each subscale can be scored separately.24 The three subscales have demonstrated good reliability and criterion related validity in a variety of samples.24,25

    Baseline and 6 weeks

Secondary Outcomes (5)

  • Stress

    Baseline and 6 weeks

  • Anxiety

    Baseline and 6 weeks

  • Trait Mindfulness

    Baseline and 6 weeks

  • State mindfulness

    6 weeks

  • Heart Rate Variability (HRV)

    6 weeks

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

Meditation is a practice of mental exercises designed to increase focus and cultivate a desire to relieve suffering in self and other. Many religious traditions have a form of meditation based practice. This study will focus on two forms of meditation both of which are focused on right mindfulness: 1) zazen which is a seated meditation primarily focused on the breath, posture, and sensation without attaching judgment. This is meant to develop awareness, equanimity, and insight, and 2) kinhin which is a walking meditation which is meant to connect mindfulness in one's movement by synchronizing breath and movement. It also focuses on development of awareness, equanimity, and insight. The two activities combined help the individual to nurture a thread of mindfulness. Instructors have developed a protocol to standardize the delivery of the meditation. Participants are requested to attend two meditation sessions per week.

Behavioral: Yoga

Mindfulness Yoga

ACTIVE COMPARATOR

Yoga is a holistic, multidimensional practice. There are three fundamental limbs of yoga: 1) breathwork (pranyanma), 2) physical postures with breathing techniques (asanas), and 3) meditation and visualization (Dhyana).) Yoga practice unites the mind, body and spirit leading to psychophysiological changes within the individual including improved self-regulation ability and stress response, mood, well-being, and quality of life. Yoga instructors will offer modifications and props such as blocks to ensure sessions are accessible to individuals of various abilities and minimize the risk of injury. Instructors have developed a detailed manual to standardize the delivery of the yoga intervention. Participants are requested to attend two yoga sessions per week.

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

Each person will participate in seated meditation, then walking meditation, then return to seated meditation.

Mindfulness Yoga
YogaBEHAVIORAL

Each person will participate in a yoga sessions.

Mindfulness Meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • in general good health
  • employed as College of Nursing (CON) faculty or CON staff
  • reside in the state of New Mexico and able to attend 6 weeks of in-person research sessions
  • willing to complete research assessments
  • own a smart phone

You may not qualify if:

  • major medical illness making individual unable to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico College of Nursing

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Interventions

MeditationYoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sharon Ruyak

    UNM HSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Study Design This study is a minimal-risk, single-site, quasi-experimental study designed to evaluate the feasibility and preliminary efficacy of mindfulness-based interventions (MBIs) among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON). Participants will be assigned to one of two intervention groups: (1) mindfulness meditation or (2) yoga. The study will assess psychosocial and physiological outcomes pre- and post-intervention. Blinding Blinding is not applicable in this study, as participants will be aware of their assigned intervention. Participant Selection and Eligibility Criteria Recruitment and Screening The study will use convenience sampling to recruit and enroll 60 participants from among the 71 faculty and 71 staff members at UNM CON. Study staff will contact interested individuals, who will undergo an eligibility screening via a one-page questionnaire (\~5 minutes to complete). Screening will assess inclusion and exclusion criteria (Attac
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

April 29, 2025

Primary Completion

October 14, 2025

Study Completion

October 14, 2025

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations