Clinical trial NCT05468112: Improving Wellbeing of SHP Personnel at UAB
Official title: Improving Wellbeing of SHP Personnel at UAB
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress, Psychological
Keywords: Mindfulness
Breathing
Meditation
Stress reduction
SKY Yoga
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PERCEIVED STRESS SCALE
timeFrame: Pre/post-intervention with 8 week followup
measure: Brief-COPE
timeFrame: Pre/post-intervention with 8 week followup
measure: Pittsburgh Sleep Quality Assessment
timeFrame: Pre/post-intervention with 8 week followup
measure: Mini-Mood and Anxiety Symptom Questionnaire
timeFrame: Pre/post-intervention with 8 week followup
measure: The Social Connectedness Scale - Revised
timeFrame: Pre/post-intervention with 8 week followup
measure: SF-12v2
timeFrame: Pre/post-intervention with 8 week followup
Secondary outcomes:
measure: Open Ended Questions
timeFrame: Weekly after 8 weeks
measure: Focus Groups
timeFrame: After participation in sessions at 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.