Health and Wellbeing of Occupational Therapy StudentsNCT05956756
Resilience Programming for Occupational Therapy Students
A study testing Health and resiliency programming in people with Health and Wellbeing of Occupational Therapy Students, run by Loma Linda University at 1 site in United States.
Trial 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. Determine if students perceive health and resiliency programming as beneficial for their health and well-being 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health and Wellbeing of Occupational Therapy Students
- What is being tested?
- Health and resiliency programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda Universtiy
Loma Linda, California, 92350
Dragana Krpalek, PhD, 909-558-4628, dkrpalek@llu.edu
Dragana Krpalek, PhD
About this study
Official title: Effectiveness of Health and Resilience Programming for Occupational Therapy Students
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:
Read more
- Determine if students perceive health and resiliency programming as beneficial for their health and well-being
- Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
- Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs
Students will engage in resilience programming as part of their regular coursework and be invited to complete pre and post assessments to test the effectiveness of programming.
Read the detailed description
University students are experiencing more challenges with anxiety, depression, and mental health. Health and resiliency programs embedded into the 3-year course curriculum may improve student health and wellness.
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.
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.
Objectives:
Determine if students perceive health and resiliency programming as beneficial for their health and well-being
Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs
- Being tested
- Health and resiliency programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and resiliency programmingBehavioural
Students will engage in resilience programming as part of their regular coursework including mindfulness training, lifestyle medicine interventions, and creating a coping plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Occupational therapy students will engage in health and resiliency programming as part of their course work over their three year program. Receives: Behavioral: Health and resiliency programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start7 Aug 2023
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health and Wellbeing of Occupational Therapy StudentsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956756
- Sponsor's protocol ID
- 5220395
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share data from the overall group, reporting on averages, ranges and statistical output.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health and Resilience Programming for Occupational Therapy Students
- ClinicalTrials.gov ID
- NCT05956756
- Acronym / sponsor ID
- 5220395
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Jul 2023 (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.
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:
- Determine if students perceive health and resiliency programming as beneficial for their health and well-being
- Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
- Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs
Students will engage in resilience programming as part of their regular coursework and be invited to complete pre and post assessments to test the effectiveness of programming.
Detailed description
University students are experiencing more challenges with anxiety, depression, and mental health. Health and resiliency programs embedded into the 3-year course curriculum may improve student health and wellness.
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.
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.
Objectives:
Determine if students perceive health and resiliency programming as beneficial for their health and well-being
Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health and resiliency programmingOccupational therapy students will engage in health and resiliency programming as part of their course work over their three year program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Health and resiliency programmingStudents will engage in resilience programming as part of their regular coursework including mindfulness training, lifestyle medicine interventions, and creating a coping plan. | Behavioural | Intervention |
Primary outcome
Health Promoting Lifestyle II (Walker, Sechrist, & Pender, 1987)
Time frame: Three years
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".
Rosenberg Self-Esteem Scale (Rosenberg, 1989)
Time frame: Three years
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."
State Adult Attachment Measure (Gillath et al., 2009)
Time frame: Three years
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."
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)
Time frame: Three years
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."
General Anxiety Disorder (GAD-7; Williams, 2014)
Time frame: Three years
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."
15-Facet mindfulness questionnaire (Baer et al., 2008)
Time frame: Three years
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."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. We plan to share data from the overall group, reporting on averages, ranges and statistical output.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and resiliency programming in people with Health and Wellbeing of Occupational Therapy Students, run by Loma Linda 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 5 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dragana Krpalek, PhD (9095584628 ext. 41340, dkrpalek@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Promoting Lifestyle II (Walker, Sechrist, & Pender, 1987) (time frame: Three years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.