Clinical trial NCT06230874: Effectiveness of Mindfulness Protocols Among OT Students
Official title: Effectiveness of Mindfulness Protocols Among Occupational Therapy Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Protocols
Keywords: Mindfulness
Stress
Engagement
Student
Occupation
Lead sponsor: Huntington University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned to one of two groups in parallel for the duration of the study.
Primary purpose: OTHER

Brief summary: The research will study the effectiveness of mindfulness protocols for OT students to decrease stress and re-engage in meaningful occupations after becoming disengaged.

Detailed description: The current study aims to investigate the effectiveness of a mindfulness protocol for OT students to decrease stress and reengage in meaningful occupations after becoming disengaged.

Anticipated benefits for participants include learning mindfulness techniques that may aid in stress reduction and promotion of re-engagement in meaningful occupations, such as schoolwork. Additionally, the results of this study can provide future OT students with information related to the effectiveness of mindfulness and re-engagement protocol.

Procedures:

Recruitment:

The research team will attempt to recruit at least 50 participants for this study using convenience and snowball sampling methods. An email invitation with a recruitment flyer will be sent to program directors of accredited entry-level graduate OT programs in the continental United States to invite potential participants interested in the study. Snowball sampling methods will also be utilized by sharing the recruitment flyer on OT social media sites, and through email to student representatives of OT associations and to faculty and student contacts. A Formstack link will be provided in the email invitation for interested participants to complete a short survey to determine if they meet the inclusion criteria. Participants must voluntarily sign a consent form on Formstack to participate in the study. Recruitment will begin following IRB committee approval and continue until mid-January 2024.

Enrollment:

Immediately following the recruitment period, voluntary participants that meet the inclusion/exclusion criteria on an interest survey and complete the voluntary consent form via Formstack will be enrolled in the study. Study participants will be given a numerical identifier for the duration of the research study. The investigators will be blinded to participants' names prior to randomizing the sample. The research support team will randomize the sample into one of two groups (experimental and control) utilizing a random number generator. The investigators will not have knowledge of the interventions assigned to individual participants.

Data Collection:

Following randomization, the participants will be emailed with their numerical identifier and information on how to access the pre assessments. Pre assessments will include a demographic survey, the COPE Inventory, and the PSS. Following completion of the pre assessments, participants will be given information on how to access their designated virtual mindfulness training (experimental or control). The experimental group will complete a 1-1.5 hour training in the use of the HOME Protocol, which was developed and pilot tested. The control group will complete an alternate 1-1.5 hour training in mindfulness that focuses on self-talk and journaling strategies. The mindfulness trainings were originally developed in 2020 by Huntington University OTD faculty and students and have been updated by the current researchers for use in this study. Scripts written by the researchers will be used in each training to ensure standardization for future studies. The timeframe for each virtual training will take 1-1.5 hours. Upon completion of the virtual training, participants will utilize their specific mindfulness protocol in accordance with the training received. Each protocol will take nine minutes to complete. The participants will be asked to complete their designated research protocol checklist using a virtual platform at least once a week for four weeks. Participants will record their perceived levels of stress, engagement, difficulty and meaningfulness of the activity, and other feelings before and after each use of their respective protocol checklist via a virtual survey platform. Participants will be sent weekly email reminders to complete their mindfulness protocols and checklists during the 4-week intervention period.

At the end of the four-week intervention period, participants will be emailed information on how to access the post assessments, which include the PSS and the COPE Inventory.

Participants will be incentivized with a random drawing consisting of two $50 gift cards for completing the entirety of the research study. Only the names of participants who complete their respective mindfulness protocol a minimum of once per week for four weeks and complete the 1-1.5 hour virtual training and pre and post assessments will be included for the random incentive drawing that will occur at the end of the intervention and data collection period. Participants that complete the entirety of the study will also be offered the opportunity to receive a 1-1.5 hour virtual training in the alternate mindfulness protocol approximately one month following the completion of the research.

Data analysis and Hypotheses:

Pre and post assessment data of the PSS and COPE Inventory will be analyzed for significant changes from pre assessment to post assessment scores and responses. Data from the experimental and control group protocol checklists will be compiled and analyzed for significant changes during the intervention process.

Following 4 weeks of protocol use, the null hypotheses propose: no statistically significant differences between the experimental and control groups for the Perceived Stress Scale (PSS) and the Coping Orientation to Problems Experienced (COPE) Inventory change scores pre and post intervention. Additionally, to determine the immediate effect of protocol use, the change scores of the protocol checklist Likert scales collected in the first and last minutes during the 9-minute protocol will be examined. Data from week 4 will be used because the participants will be most familiar with their protocol use by this time. The null hypotheses propose: no statistically significant differences between experimental and control groups for the protocol checklist Likert scales stress or engagement change scores in week 4; and no statistically significant differences within groups for reported stress or engagement immediately after the use of the protocol in week 4. The alpha level is set at 0.01.

During the data collection and analysis process, all participants will be assigned a numeric identifier and de-identified data will be kept private on password-protected computers using Excel or a similar platform. A master list of the participants in the experimental and control groups with their corresponding email and numerical identifiers will be printed and kept in a locked box in a secure cabinet on the 3rd floor of the Huntington University OTD Program at 1819 Carew St., Fort Wayne, IN 46805. The master list will be kept private and separate from the numerical data. All electronic data, including data sets from the pre and post assessments, and protocol data, will be stored for a minimum of three years on an OTD program password-protected computer. All printed data will be kept for a minimum of three years in a secure cabinet of the Huntington University OTD Program.

This study presents minimal risks to participants. The greatest risk is emotional distress participants may feel related to self-reflection on stress levels. Additionally, there is a time requirement for virtual completion of the training, protocol checklists, and pre/post assessments.

Researchers have attempted to reduce potential risk by keeping the length of the virtual training to 1-1.5 hours. Additionally, the participants' mindfulness protocols will require only 9 minutes to complete and at a minimum of once a week for four weeks. There is a potential risk for a breach of confidentiality due to the use of virtual training and electronic data collection methods. The researchers have attempted to reduce risk by utilizing numerical identifiers throughout the research process. Subject numbers will be kept on a private confidential master list to ensure anonymity.

Eligibility criteria: Inclusion Criteria

* 18 years or older
* Currently in an accredited entry-level graduate OT program in the continental United States
* Must complete pre and post assessments.
* Must complete a one-time 1-1.5-hour virtual mindfulness training.
* Must utilize the mindfulness research protocol for at least once a week for a four-week period.

Exclusion Criteria:

* Under 18 years
* Not enrolled in an accredited entry-level graduate OT program in the continental US.
* Must complete pre and post assessments.
* Must complete a one-time 1-1.5-hour virtual mindfulness training
* Must utilize research protocol at least once a week for a four-week period.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Through study completion, up to two weeks
measure: Coping Orientation to Problems Experienced (COPE) Inventory
timeFrame: Through study completion, up to two weeks
measure: Protocol Checklist
timeFrame: Week 4 Data
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Huntington University
state: Indiana
Study officials:
References:
citation: Gerig, L., Henton, P., Butterweck, M., Swider, J., Cameron, L., Marihugh, K., & Close, K. (2023). Stress, Mindfulness and Occupational Engagement: A Pilot Study of the HOME Protocol. Journal of Occupational Therapy Education, 7 (2). https://doi.org/10.26681/jote.2023.070204
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citation: Roberti, J. W., Harrington, L. N., & Storch, E. A. (2006). Further psychometric support for the 10-item version of the Perceived Stress Scale. Journal of College Counseling, 9(2), 135-147. https://doi.org/10.1002/j.2161-1882.2006.tb00100.x