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Improving Wellbeing of SHP Personnel at UAB (SHPwell)

Primary Purpose

Stress, Psychological

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SKY Meditation and Mindfulness
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Mindfulness, Breathing, Meditation, Stress reduction, SKY Yoga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

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

Exclusion criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Sky Meditation and Mindfulness Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    The Social Connectedness Scale - Revised
    This scale assesses the degree to which persons feel connected to others in their social environment.
    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.

    Secondary Outcome Measures

    Open Ended Questions
    Qualitative questions of well-being
    Focus Groups
    Group discussion with transcript

    Full Information

    First Posted
    July 19, 2022
    Last Updated
    March 23, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05468112
    Brief Title
    Improving Wellbeing of SHP Personnel at UAB
    Acronym
    SHPwell
    Official Title
    Improving Wellbeing of SHP Personnel at UAB
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Insufficient resources for performance of project
    Study Start Date
    November 15, 2024 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Students/staff/faculties of SHP will be offered to participate in the SKY Breath Happiness workshop followed by participating in a research program designed to study the potential effectiveness of the SKY Breath Happiness Program as a stress-management, resilience building wellness tool in this population. They will be given an informed consent form to sign if they choose to participate in the study. The course that the students are enrolled in is the SKY program, which is an evidence-based bio-psycho-social program that utilizes a multi-dimensional relationship between biology and behavior. 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. There will also be one mandatory one hour follow-up session one week later. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological
    Keywords
    Mindfulness, Breathing, Meditation, Stress reduction, SKY Yoga

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sky Meditation and Mindfulness Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SKY Meditation and Mindfulness
    Other Intervention Name(s)
    SKY Yoga, Sudarshan Kriya Yoga
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    PERCEIVED STRESS SCALE
    Description
    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.
    Time Frame
    Pre/post-intervention with 8 week followup
    Title
    Brief-COPE
    Description
    The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.
    Time Frame
    Pre/post-intervention with 8 week followup
    Title
    Pittsburgh Sleep Quality Assessment
    Description
    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.
    Time Frame
    Pre/post-intervention with 8 week followup
    Title
    Mini-Mood and Anxiety Symptom Questionnaire
    Description
    The Mood and Anxiety Symptom Questionnaire (MASQ) is an instrument containing a range of symptoms relevant to depression and anxiety.
    Time Frame
    Pre/post-intervention with 8 week followup
    Title
    The Social Connectedness Scale - Revised
    Description
    This scale assesses the degree to which persons feel connected to others in their social environment.
    Time Frame
    Pre/post-intervention with 8 week followup
    Title
    SF-12v2
    Description
    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.
    Time Frame
    Pre/post-intervention with 8 week followup
    Secondary Outcome Measure Information:
    Title
    Open Ended Questions
    Description
    Qualitative questions of well-being
    Time Frame
    Weekly after 8 weeks
    Title
    Focus Groups
    Description
    Group discussion with transcript
    Time Frame
    After participation in sessions at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Healthy students/faculty/staff who at UAB, School of Health Professionals Willingness to complete all study interventional components Exclusion criteria: Inability to understand standard English Previous participation in a SKY intervention Pregnant persons Diagnosis of bipolar disorder or schizophrenia

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27898207
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32665041
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32760296
    Citation
    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.
    Results Reference
    result

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    Improving Wellbeing of SHP Personnel at UAB

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