Effectiveness of Mindfulness Protocols Among OT Students
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedStudy Start
First participant enrolled
January 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2024
CompletedOctober 8, 2024
October 1, 2024
2 months
January 19, 2024
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Perceived Stress Scale (PSS)
The PSS is a questionnaire composed of 10 questions to assess perceptions of stress and the degree to which one perceives life situations as stressful. Literature supports the PSS as a valid and reliable assessment of perceived stress of university students.
Through study completion, up to two weeks
Coping Orientation to Problems Experienced (COPE) Inventory
The COPE is self-report instrument composed of 60 questions to assess people's stress responses. For this study, we will use the behavioral disengagement and mental disengagement scales to measure the participants' response to stress prior to and following the intervention period.
Through study completion, up to two weeks
Protocol Checklist
Each protocol (HOME Protocol and Control Journaling Protocol) has a checklist that is embedded in the protocol measures the student's perceived level of stress, engagement, challenge, and meaning of the activity that they disengage from. Four Likert rating scales (0 representing the lowest score and 10 representing the highest score) are embedded in the first minute and final minute of the protocol to record students' self-assessments pre and post intervention in the following areas: stress, engagement, challenge, and meaning. By the 4th week of the intervention the student participants are most likely to have learned to use their respective protocols; therefore, the study will utilize only week 4 protocol data to determine between group and within group differences of the stress and engagement scale change scores immediately following use of the protocols.
Week 4 Data
Study Arms (2)
HOME Protocol
EXPERIMENTALWill receive the HOME Protocol Intervention
Control Journaling Protocol
ACTIVE COMPARATORWill receive the Control Journaling Protocol
Interventions
The HOME Protocol is a newly developed nine-minute mindfulness and engagement protocol designed to decrease stress and to promote re-engagement in meaningful occupations of daily life by applying mindfulness strategies in a specific, timed format. The protocol requires special training for students: a) to recognize times of disengagement in occupations, and b) to learn how to apply specific mindfulness strategies to increase re-engagement in meaningful occupations. Five components of the HOME Protocol include Reflect (1 minute of self-reflection and self-talk), Reset (2 minutes for breathing with stillness/silence and body check), Reach (3 minutes for stretching and progressive muscular relaxation), Renew (2 minutes for breathing with meditation/gratitude), and Re-engage (1 minute for self-reflection and self-talk).
The control journaling protocol is a nine-minute mindfulness and engagement protocol designed to decrease stress and to promote re-engagement in meaningful occupations of daily life by applying mindfulness self-talk and journaling strategies in a specific, timed format. The protocol requires special training for students: a) to recognize times of disengagement in occupations, and b) to learn how to apply specific mindfulness strategies to increase re-engagement in meaningful occupations. Three components of the control journaling protocol include Reflect (1 minute of self-reflection and self-talk), Write (journaling), and Re-engage (1 minute for self-reflection and self-talk).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeanne Sowerslead
Study Sites (1)
Huntington University
Fort Wayne, Indiana, 46805, United States
Related Publications (6)
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
BACKGROUNDCarver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
PMID: 2926629BACKGROUNDCohen 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: 6668417BACKGROUNDCohen, S., & Williamson, G. (1988). Perceived stress in a probability sample of the United States. In S. Spacapam & S. Oskamp (Eds.) The Social Psychology of Health (pp. 31-67). Sage Publications.
BACKGROUNDLee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18.
PMID: 25031113BACKGROUNDRoberti, 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
BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Individual participants will only have knowledge of their own intervention protocol. The investigators will be blinded to the randomization process and will not have knowledge of the interventions assigned to individual participants.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Program Director
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 30, 2024
Study Start
January 31, 2024
Primary Completion
March 18, 2024
Study Completion
April 16, 2024
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share