Effect of a Daily Meditation Intervention in Student Pharmacists

NCT05154565 | Completed

• 1 other identifier: 21029
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Resilience, Psychological; Mindfulness; Meditation; Well-being

Keywords

Pharmacy, Students; Education, Pharmacy

Outcome Measures

Primary Outcomes (4)

• Change from baseline in stress at 30 days

  The change in perceived stress as measured by the Perceived Stress Scale four (4)-item measure (PSS-4; Cohen, Kamarck, \& Mermelstein, 1983) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). The PSS-4 yields a total score from 0 to 16 with higher scores indicating more stress.

  30 days

• Change from baseline in mindfulness at 30 days

  The change in self-reported mindfulness as measured by the Five Facets of Mindfulness Questionnaire fifteen (15)-item measure (FFMQ-15; Baer, Smith, Lykins, et al., 2008) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Based on recommendations by Gu, Strauss, Crane, et al (2016), only four factors will be analyzed for change: describing, acting with awareness, non-judging, non-reactivity. Scores are derived by taking the mean response from all items and separately for each domain. Mean scores range from 1 to 5 with higher scores indicating higher levels of mindfulness.

  30 days

• Change from baseline in overall well-being at 30 days

  The change in overall well-being as measured by the World Health Organization five (5)-item subjective well-being measure (WHO-5; World Health Organization, 1988) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Scores are calculated by summing the responses for each item and then multiplying by four (4). The final score ranges from 0 to 100 with higher scores indicating better well-being.

  30 days

• Change from baseline in resilience at 30 days

  The change in resilience as measured by the six (6)-item Brief Resilience Scale (BRS; Smith, Dalen, Wiggins, et al., 2008) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Scores are calculated by summing the responses for each item and then dividing by six (6) to yield an overall mean score. The overall mean score ranges from 1 to 5 with higher scores indicating greater resilience.

  30 days

Secondary Outcomes (4)

• Frequency of meditation app usage

  90 days

• Acceptability of the meditation app (participant questionnaire)

  30 days

• Continued use of meditation (participant questionnaire)

  30 days

• Experience with the meditation app (participant focus group)

  120 days

Other Outcomes (4)

• Change from baseline in stress at 90 days

  90 days

• Change from baseline in mindfulness at 90 days

  90 days

• Change from baseline in overall well-being at 90 days

  90 days

Study Arms (2)

Immediate intervention (Group A)

EXPERIMENTAL

Meditation intervention applied during Phase 1 of the study. During Phase 2, the formal meditation intervention is not completed, but participants are followed for outcome measurement. Participants may continue to use meditation in their daily routines or return to their usual routines.

Behavioral: Guided meditation

Delayed intervention (Group B)

OTHER

No intervention is applied in Phase 1 of the study. This group serves as the control group for Phase 1. The meditation intervention is applied in Phase 2 of the study.

Behavioral: Guided meditation

Interventions

Guided meditation BEHAVIORAL

App-based guided meditation intervention through Headspace. This can be accessed through various mobile devices.

Also known as: Headspace

Delayed intervention (Group B); Immediate intervention (Group A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Midwestern University College of Pharmacy

Downers Grove, Illinois, 60515, United States

Location

Related Publications (5)

• 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.

  PMID: 18696313 BACKGROUND

• 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.

  PMID: 18310597 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 27078186 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kathy Komperda, PharmD

  Midwestern University

  PRINCIPAL INVESTIGATOR

• Spencer E Harpe, PharmD, PhD

  Midwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacy

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: December 13, 2021
• Study Start: December 2, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 9, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)