NCT05956756

Brief Summary

The purpose of this study is to explore the effectiveness of integrated health and resiliency programs into the Entry-Level Doctor of Occupational therapy curriculum. The objectives are to:

  1. 1.Determine if students perceive health and resiliency programming as beneficial for their health and well-being
  2. 2.Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
  3. 3.Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress44%
Aug 2023Dec 2029

First Submitted

Initial submission to the registry

July 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5.9 years

First QC Date

July 12, 2023

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Health Promoting Lifestyle II (Walker, Sechrist, & Pender, 1987)

    This questionnaire contains 52 statements about respondents' present way of life or personal habits. Respondents are asked to respond to each item as accurately as possible on a 4-point Likert scale (never, sometimes, often, routinely). Example items include "Inspect my body at least monthly for physical changes/danger signs".

    Three years

  • Rosenberg Self-Esteem Scale (Rosenberg, 1989)

    Include a list of 10 statements dealing with general feelings about oneself. Respondents are asked to indicate how strongly they agree or disagree with each statement on a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). An example item is "I am able to do things as well as most other people."

    Three years

  • State Adult Attachment Measure (Gillath et al., 2009)

    Contains 21 statements concerning how the respondent feels right now in their relationship with others and self. Respondents indicate how much they agree or disagree with the statement as it reflects their current feelings on a 7-point sliding scale with 7 indicating 'agree strongly'. An example statement is "I wish someone close could see me now."

    Three years

  • Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)

    Asks respondents to indicate how often they have been bothered by any of the following nine problems listed, over the last 2 weeks. Respondents use a 4-point Likert scale (not at all, several days, more than half the days, nearly everyday). An example statement is "Poor appetite or overeating."

    Three years

  • General Anxiety Disorder (GAD-7; Williams, 2014)

    Asks respondents to indicate how often they have been bothered by any of the following seven problems listed, over the last 2 weeks. Respondents use a 4-point Likert scale (not at all, several days, more than half the days, nearly everyday). An example problem is "Not being able to stop or control worrying."

    Three years

  • 15-Facet mindfulness questionnaire (Baer et al., 2008)

    Contains 15-items related to mindfulness. Respondents rate how much they agree with each item on a 5-point Likert scale (very often or always, often true, sometimes true, rarely true, very rarely true). An example item is "When I have distressing thoughts or images I just notice them and let them go."

    Three years

Study Arms (1)

Intervention

EXPERIMENTAL

Occupational therapy students will engage in health and resiliency programming as part of their course work over their three year program.

Behavioral: Health and resiliency programming

Interventions

Students will engage in resilience programming as part of their regular coursework including mindfulness training, lifestyle medicine interventions, and creating a coping plan.

Intervention

Eligibility Criteria

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

You may qualify if:

  • students enrolled in the Entry Level Doctor of Occupational Therapy program at Loma Linda University
  • Enrolled during June 2023 to June 2029
  • Between 18-65 years of age
  • Of any gender
  • Of any ethnic background

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda Universtiy

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Central Study Contacts

Dragana Krpalek, PhD

CONTACT

Heather Javaherian, OTD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study will utilize a quasi-experimental design to explore the effectiveness of health and resilience programming for occupational therapy students while they are enrolled in the program. Pre and post data will be gathered through questionnaires. Additionally, qualitative data will be obtained from student discussion board posts/assignments, interviews or focus groups will be used to supplement the quantitative data.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 21, 2023

Study Start

August 7, 2023

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

We plan to share data from the overall group, reporting on averages, ranges and statistical output.

Locations