Improving Wellbeing of SHP Personnel at UAB (SHPwell)

March 23, 2023 updated by: Keith McGregor, University of Alabama at Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Pariya Yaghoubi Jami, PhD
  • Phone Number: (205) 996-1422
  • Email: pyaghoub@uab.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sky Meditation and Mindfulness Intervention
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
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.
Other Names:
  • Sudarshan Kriya Yoga
  • SKY Yoga

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PERCEIVED STRESS SCALE
Time Frame: Pre/post-intervention with 8 week followup
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
Time Frame: Pre/post-intervention with 8 week followup
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
Time Frame: Pre/post-intervention with 8 week followup
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
Time Frame: Pre/post-intervention with 8 week followup
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
Time Frame: Pre/post-intervention with 8 week followup
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
Time Frame: Pre/post-intervention with 8 week followup
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Open Ended Questions
Time Frame: Weekly after 8 weeks
Qualitative questions of well-being
Weekly after 8 weeks
Focus Groups
Time Frame: After participation in sessions at 12 weeks
Group discussion with transcript
After participation in sessions at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300008660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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