Clinical trial NCT05154565: Effect of a Daily Meditation Intervention in Student Pharmacists
Official title: The Effect of Daily Meditation on Stress, Mindfulness, Well-being, and Resilience in Student Pharmacists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Resilience, Psychological
Mindfulness
Meditation
Well-being
Keywords: Pharmacy, Students
Education, Pharmacy
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to two (2) groups. Group A is an immediate intervention group while Group B is a delayed intervention group. This allows the short-term effects of intervention to be estimated by comparing study outcomes in the treated group (Group A) with the comparison group (Group B) in Phase 1.
Primary purpose: PREVENTION

Brief summary: Pharmacy school is a 3-to-4 year intensive program that demands a high level of performance from enrolled students. The fast-paced and challenging curriculum causes stress levels to rise in students. The increase in stress can negatively affect performance in the classroom, as well as affect relationships outside the classroom setting. While some level of stress may be beneficial, the substantial amount of stress experienced by pharmacy students may also negatively impact their quality of life. This proposed study aims to explore the effect a convenient intervention on perceived stress, mindfulness, well-being, and resilience as reported by student pharmacists. Headspace will be used as the main study intervention. This product is a mobile device application (aka, an app) that teaches users how to meditate through guided exercises. It contains a library of different meditation exercises the user can access from their smartphone or tablet at their own convenience. It is our hope that the use of Headspace will enhance the students' ability to practice mindfulness, which will allow them to better cope with stress in school and in future practice. This could translate into improved learning and overall well-being.

Detailed description: This research study aims to implement a mindfulness meditation routine delivered via the smartphone application Headspace to decrease perceived stress and improve well-being, resilience, and mindfulness in student pharmacists. This product is a mobile device application (aka, an app) that teaches users how to meditate through guided exercises. It contains a library of different meditation exercises the user can access from their smartphone or tablet at their own convenience. The use of a smartphone application will allow for convenience to promote adherence with the intervention among participants. The guided meditation sessions will teach participants how to live in the present moment and handle stressful situations that may arise in the future. As a result of this program the investigators expect to see an inverse relationship between mindfulness meditation and perceived stress and direct relationships between mindfulness meditation and well-being and resilience. By learning to incorporate mindfulness meditation into their lives, participating student pharmacists may be able to develop useful tools and effectively combat overwhelming situations they may face in the future.

This study will be conducted in two phases. Participating student pharmacists will be randomly assigned to one of two groups. In Phase 1, Group A will complete four (4) weeks of guided meditation while Group B does not use the application for meditation. Changes in study outcomes will be compared from baseline to the end of the initial intervention period. In Phase 2, Group B will be complete the guided meditation intervention. Group A will continue their usual daily habits. It is possible for some students from Group A may continue to use Headspace or another similar product to continue to incorporate meditation or mindfulness into their daily routine. At the end of Phase 2, the changes in study outcomes will be examined in Group B surrounding their use of the intervention. Outcomes will also be assessed in Group A at the end of Phase 2 to examine whether there are sustained changes in study outcomes and continued usage of meditation or mindfulness practices. All participating student pharmacists will also be invited to participate in one of several focus groups sessions to discuss experiences with the use of the guided meditation application.

Eligibility criteria: Inclusion Criteria:

* Student pharmacists enrolled in the didactic curriculum in the Doctor of Pharmacy (PharmD) program during the Winter 2021/2022 quarter at the sponsoring institution

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from baseline in stress at 30 days
timeFrame: 30 days
measure: Change from baseline in mindfulness at 30 days
timeFrame: 30 days
measure: Change from baseline in overall well-being at 30 days
timeFrame: 30 days
measure: Change from baseline in resilience at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Frequency of meditation app usage
timeFrame: 90 days
measure: Acceptability of the meditation app (participant questionnaire)
timeFrame: 30 days
measure: Continued use of meditation (participant questionnaire)
timeFrame: 30 days
measure: Experience with the meditation app (participant focus group)
timeFrame: 120 days
Other outcomes:
measure: Change from baseline in stress at 90 days
timeFrame: 90 days
measure: Change from baseline in mindfulness at 90 days
timeFrame: 90 days
measure: Change from baseline in overall well-being at 90 days
timeFrame: 90 days
measure: Change from baseline in resilience at 90 days
timeFrame: 90 days
Locations:
city: Downers Grove
country: United States
facility: Midwestern University College of Pharmacy
state: Illinois
Study officials:
affiliation: Midwestern University
name: Kathy Komperda, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwestern University
name: Spencer E Harpe, PharmD, PhD
role: STUDY_DIRECTOR
References:
citation: Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
citation: Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
citation: Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. Examining the factor structure of the 39-item and 15-item versions of the Five Facet Mindfulness Questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016 Jul;28(7):791-802. doi: 10.1037/pas0000263. Epub 2016 Apr 14.