NCT05468112

Brief Summary

The main objective of this study is to evaluate the impact of a well-being program, SKY Campus Happiness, on well-being of students, faculties, and staff working/studying at School of Health Professional (SHP). SHP is leaning on the SKY Campus Happiness (SKY) program which is an integrative workshop format that includes both skill-building and group dynamics and may be critical for the effectiveness of the program. SKY is a university leadership and well-being program (campushappiness.org) that includes stress-management and tools for psychological resilience: yoga postures, breathing exercises, a breath-based meditation technique \[Sudarshan Kriya Yoga\]. SKY also includes positive psychology skills (e.g., gratitude, social connection, acts of kindness, meaning and purpose). In addition, the curriculum includes discussion and application of leadership skills and service learning. Relying on existing evidence of previous studies, we hypothesize that participating in this program will increase the well-being of people involved.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2024

Status
withdrawn

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

July 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

July 19, 2022

Last Update Submit

March 23, 2023

Conditions

Keywords

MindfulnessBreathingMeditationStress reductionSKY Yoga

Outcome Measures

Primary Outcomes (6)

  • PERCEIVED STRESS SCALE

    The Perceived Stress Scale(PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.

    Pre/post-intervention with 8 week followup

  • Brief-COPE

    The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.

    Pre/post-intervention with 8 week followup

  • Pittsburgh Sleep Quality Assessment

    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.

    Pre/post-intervention with 8 week followup

  • Mini-Mood and Anxiety Symptom Questionnaire

    The Mood and Anxiety Symptom Questionnaire (MASQ) is an instrument containing a range of symptoms relevant to depression and anxiety.

    Pre/post-intervention with 8 week followup

  • The Social Connectedness Scale - Revised

    This scale assesses the degree to which persons feel connected to others in their social environment.

    Pre/post-intervention with 8 week followup

  • SF-12v2

    The SF-12v2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health.

    Pre/post-intervention with 8 week followup

Secondary Outcomes (2)

  • Open Ended Questions

    Weekly after 8 weeks

  • Focus Groups

    After participation in sessions at 12 weeks

Study Arms (1)

Sky Meditation and Mindfulness Intervention

EXPERIMENTAL

In person meditation classes will be 3 hours long on each of three consecutive days, and participants must be willing to attend all three sessions. An additional 7 online sessions will be delivered to participants in successive days after the initial in-person intervention. Participants will be asked to engage in daily 10 to 25 minute home resilience practice sessions performed five days per week. To support participants stabilization of the practices, optional daily guided practice will be offered online at a determined convenient time for all participants to allow full participation. The breathing techniques will be taught by certified instructors.

Behavioral: SKY Meditation and Mindfulness

Interventions

The intervention is a 3-day in-person meditation and mindfulness workshop using the SKY meditation approach. It utilizes a unique set of standardized breathing techniques to rapidly reduce neuro-endocrine stress responses and the autonomic imbalance due to sympathetic overdrive, thus restoring autonomic homeostasis. These are interwoven with coping and stressor appraisal strategies, and simple stretching exercises. Classes will be 3 hours long on each of three consecutive days, and participants must be willing to attend all three sessions with an additional 7 consecutive days of online sessions immediately thereafter. In addition, participants will be asked to engage in daily 10 to 25 minute home resilience practice sessions performed five days per week. They will complete a follow-up session once per week in the subsequent 8 weeks.

Also known as: SKY Yoga, Sudarshan Kriya Yoga
Sky Meditation and Mindfulness Intervention

Eligibility Criteria

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

You may qualify if:

  • Healthy students/faculty/staff who at UAB, School of Health Professionals
  • Willingness to complete all study interventional components

You may not qualify if:

  • Inability to understand standard English
  • Previous participation in a SKY intervention
  • Pregnant persons
  • Diagnosis of bipolar disorder or schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sharma A, Barrett MS, Cucchiara AJ, Gooneratne NS, Thase ME. A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. J Clin Psychiatry. 2017 Jan;78(1):e59-e63. doi: 10.4088/JCP.16m10819.

    PMID: 27898207BACKGROUND
  • Lai KSP, Watt C, Ionson E, Baruss I, Forchuk C, Sukhera J, Burhan AM, Vasudev A. Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial. Trials. 2020 Jul 14;21(1):648. doi: 10.1186/s13063-020-04583-w.

    PMID: 32665041BACKGROUND
  • Seppala EM, Bradley C, Moeller J, Harouni L, Nandamudi D, Brackett MA. Promoting Mental Health and Psychological Thriving in University Students: A Randomized Controlled Trial of Three Well-Being Interventions. Front Psychiatry. 2020 Jul 15;11:590. doi: 10.3389/fpsyt.2020.00590. eCollection 2020.

MeSH Terms

Conditions

Stress, PsychologicalRespiratory Aspiration

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 21, 2022

Study Start

November 15, 2024

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share