Stress, PsychologicalNCT05154565
Effect of a Daily Meditation Intervention in Student Pharmacists
A study testing Guided meditation in people with Stress, Psychological and Resilience, Psychological, run by Midwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological, Resilience, Psychological, Mindfulness
- What is being tested?
- Guided meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 9 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Student pharmacists enrolled in the didactic curriculum in the Doctor of Pharmacy (PharmD) program during the Winter 2021/2022 quarter at the sponsoring institution
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern University College of Pharmacy
Downers Grove, Illinois, 60515
About this study
Official title: The Effect of Daily Meditation on Stress, Mindfulness, Well-being, and Resilience in Student Pharmacists
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.
Read the 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.
- Being tested
- Guided meditation
- Keywords
- Pharmacy, Students, Education, Pharmacy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided meditationBehavioural
Also called Headspace
App-based guided meditation intervention through Headspace. This can be accessed through various mobile devices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Guided meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (4)
Frequency of meditation app usage
During the respective intervention periods, de-identified usage data provided by the application maker will be examined to identify patterns of usage by study participants. For Group A (immediate group), students will self-report their usage in Phase 2 of the study.
Measured: 90 days
Acceptability of the meditation app (participant questionnaire)
A questionnaire was developed for this study to measure participants' opinions of the acceptability of the meditation app used. This will be administered at the end of the respective intervention period for each group (Phase 1 for Group A and Phase 2 for Group B). The questionnaire includes items on the value meditation, ease of use, and ability to incorporate the intervention into their daily schedule. Higher scores indicate more positive responses.
Measured: 30 days
Continued use of meditation (participant questionnaire)
A questionnaire was developed for this study to measure intended use of meditation in the future. Using the theory of planned behavior as a guiding theoretical framework, the questionnaire for future use included items on intentions to practice mindfulness or meditation in the next academic quarter, attitudes towards use of mindfulness or meditation practices, subjective norms surrounding engaging in mindfulness or meditation practices, and perceived behavioral control to engage in mindfulness or meditation practices. All items are scored such that higher scores represent more positive attitudes or opinions in each area.This questionnaire will be administered at the end of the each group's respective intervention period. Higher scores indicate more positive responses.
Measured: 30 days
Experience with the meditation app (participant focus group)
Focus group sessions will be conducted to gather feedback from participants on their experiences using meditation. Qualitative analysis will be used to construct themes identified from the participant responses.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start2 Dec 2021
- Primary completion1 Mar 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spencer Harpe, Midwestern University
- Investigators
- Kathy Komperda, PharmD, Principal investigator, Midwestern UniversitySpencer E Harpe, PharmD, PhD, Study director, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154565
- Sponsor's protocol ID
- 21029
- Status last verified
- May 2022
- First submitted
- 8 Sep 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18696313Baer 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.
PubMed 18310597Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Topp 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.
PubMed 25831962Gu 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.
PubMed 27078186
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Meditation on Stress, Mindfulness, Well-being, and Resilience in Student Pharmacists
- ClinicalTrials.gov ID
- NCT05154565
- Acronym / sponsor ID
- 21029
- Keywords
- Pharmacy, Students, Education, Pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 13 Dec 2021 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention (Group A) | Experimental | Behavioral: Guided meditationMeditation 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. |
| Delayed intervention (Group B) | Other | Behavioral: Guided meditationNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Student pharmacists enrolled in the didactic curriculum in the Doctor of Pharmacy (PharmD) program during the Winter 2021/2022 quarter at the sponsoring institution
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Guided meditationAlso: HeadspaceApp-based guided meditation intervention through Headspace. This can be accessed through various mobile devices. | Behavioural | Delayed intervention (Group B), Immediate intervention (Group A) |
Primary outcome
Change from baseline in stress at 30 days
Time frame: 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.
Change from baseline in mindfulness at 30 days
Time frame: 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.
Change from baseline in overall well-being at 30 days
Time frame: 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.
Change from baseline in resilience at 30 days
Time frame: 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.
4 secondary outcomes
Frequency of meditation app usage
Time frame: 90 days
Acceptability of the meditation app (participant questionnaire)
Time frame: 30 days
Continued use of meditation (participant questionnaire)
Time frame: 30 days
Experience with the meditation app (participant focus group)
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 18696313Smith 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.
- Background: PubMed 18310597Baer 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 27078186Gu 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.
- 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.
Kathy Komperda, PharmD principal investigator
Midwestern University
Spencer E Harpe, PharmD, PhD study director
Midwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided meditation in people with Stress, Psychological and Resilience, Psychological, run by Midwestern University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in stress at 30 days (time frame: 30 days). The study lists 4 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 NCT05154565, which also lists 5 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 26 May 2022.