Improving Wellbeing of SHP Personnel at UAB

Stress, Psychological Clinical Trial

— SHPwell  

Official title:

Improving Wellbeing of SHP Personnel at UAB

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05468112
• Other study ID #: IRB-300008660
• Status: Withdrawn
• Phase: N/A
• Start date: November 15, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

References & Publications (3)

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. — View 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: 1 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Open Ended Questions	Qualitative questions of well-being	Weekly after 8 weeks
Secondary	Focus Groups	Group discussion with transcript	After participation in sessions at 12 weeks