NCT06230874

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

January 19, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

MindfulnessStressEngagementStudentOccupation

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

EXPERIMENTAL

Will receive the HOME Protocol Intervention

Behavioral: HOME Protocol

Control Journaling Protocol

ACTIVE COMPARATOR

Will receive the Control Journaling Protocol

Behavioral: Control Journaling Protocol

Interventions

HOME ProtocolBEHAVIORAL

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).

HOME Protocol

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).

Control Journaling Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Huntington University

Fort Wayne, Indiana, 46805, United States

Location

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

    BACKGROUND
  • Carver 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: 2926629BACKGROUND
  • 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: 6668417BACKGROUND
  • Cohen, 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.

    BACKGROUND
  • Lee 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: 25031113BACKGROUND
  • 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

    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
Model Details: Study participants will be randomly assigned to one of two groups in parallel for the duration of the study.
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

Locations