Stress, PsychologicalSHPwellNCT05468112
Improving Wellbeing of SHP Personnel at UAB
A study testing SKY Meditation and Mindfulness in people with Stress, Psychological, run by University of Alabama at Birmingham.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- SKY Meditation and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy students/faculty/staff who at UAB, School of Health Professionals
- Willingness to complete all study interventional components
Who cannot join
- Inability to understand standard English
- Previous participation in a SKY intervention
- Pregnant persons
- Diagnosis of bipolar disorder or schizophrenia
About this study
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- SKY Meditation and Mindfulness
- Keywords
- Mindfulness, Breathing, Meditation, Stress reduction, SKY Yoga
- Medical subject headings
- Stress, Psychological, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY Meditation and MindfulnessBehavioural
Also called SKY Yoga, Sudarshan Kriya Yoga
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SKY Meditation and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre/post-intervention with 8 week followup
Secondary outcomes (2)
Open Ended Questions
Qualitative questions of well-being
Measured: Weekly after 8 weeks
Focus Groups
Group discussion with transcript
Measured: After participation in sessions at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start15 Nov 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: Insufficient resources for performance of project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith McGregor, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468112
- Sponsor's protocol ID
- IRB-300008660
- Acronym
- SHPwell
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27898207Lai 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.
PubMed 32665041Seppala 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.
PubMed 32760296
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Wellbeing of SHP Personnel at UAB
- ClinicalTrials.gov ID
- NCT05468112
- Acronym / sponsor ID
- SHPwell / IRB-300008660
- Conditions
- Stress, Psychological
- Keywords
- Mindfulness, Breathing, Meditation, Stress reduction, SKY Yoga
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient resources for performance of project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
| Arm | Type | Receives |
|---|---|---|
| Sky Meditation and Mindfulness Intervention | Experimental | Behavioral: SKY Meditation and MindfulnessIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy students/faculty/staff who at UAB, School of Health Professionals
- Willingness to complete all study interventional components
Key exclusion criteria (4 listed)
- Inability to understand standard English
- Previous participation in a SKY intervention
- Pregnant persons
- Diagnosis of bipolar disorder or schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKY Meditation and MindfulnessAlso: SKY Yoga, Sudarshan Kriya YogaThe 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. | Behavioural | Sky Meditation and Mindfulness Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Open Ended Questions
Time frame: Weekly after 8 weeks
Focus Groups
Time frame: After participation in sessions at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 27898207Sharma 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.
- Background: PubMed 32665041Lai 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 publication: PubMed 32760296Seppala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SKY Meditation and Mindfulness in people with Stress, Psychological, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERCEIVED STRESS SCALE (time frame: Pre/post-intervention with 8 week followup). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468112, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.