NCT07846085

Brief Summary

The goal of this randomized control trial is to learn if regular administration of the Mindful Self Care Scale (MSCS) will improve graduate occupational therapy student overall psychological well being. It will also learn about specific coping skills students use, when, and how they use these. The main questions it aims to answer are: (1) Does completing regular self-care assessments improve students' overall psychological distress, resilience, or perceived social support state anxiety for the experimental group? 2\) To describe the experience of being prompted to reflect on coping behaviors during school including specific skills students use, when and how they use these. Researchers will compare regular administration of the MSCS every 3 weeks for 6 administrations to a control group who answered two generalized well being questions at the same interval. Participants will: Take the MSCS or a generalized 2 question survey every 3 weeks for a total of 6 surveys. A maximum of 20 intervention group participants will self-select to participate in a focus group upon completion of quantitative data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

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

Study Start

First participant enrolled

January 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 31, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Occupational TherapyGraduate StudentResilienceSelf-carePsychological distressSocial support

Outcome Measures

Primary Outcomes (6)

  • Brief Resilience Scale (BRS)

    The Brief Resilience Scale (BRS) is a 6-item self-report measure for adults aged 18 years and older designed to assess an individual's ability to bounce back or recover from stress, adversity, and challenging life circumstances. Minimum score is 6, maximum score is 30. Higher number means better outcome.

    From enrollment to the end of treatment at 5 months.

  • Multidimensional Scale of Perceived Social Support (MSPSS)

    The Multidimensional Scale of Perceived Social Support is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Minimum Value is 12, Maximum Value is 84. Higher score indicates better outcome.

    From enrollment to the end of treatment at 5 months.

  • Depression Anxiety Stress Scale (DASS-21)

    Depression Anxiety Stress Scale (DASS-21): The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of averaged self-report scales designed to measure the emotional states of depression, anxiety and stress. Minimum value is 0, Maximum value is 68. Lower score indicates better outcome.

    From enrollment to the end of treatment at 5 months.

  • Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index (PSQI) Total Score: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Minimum Value 0; Maximum Score 21. Lower Value indicates better outcome.

    From enrollment to the end of treatment at 5 months.

  • Perceived Stress Scale (PSS)

    Perceived Stress Scale (PSS): This self-report questionnaire is used to assess the degree to which a respondent finds circumstances in their life to be unpredictable, uncontrollable, and/or overwhelming. Minimum Value 0; Maximum Value 40. Lower score indicates better outcome.

    From enrollment to the end of treatment at 5 months.

  • The World Health Organization-Five Well-Being Index (WHO-5)

    The World Health Organization-Five Well-Being Index (WHO-5): The WHO-5 is a short questionnaire consisting of 5 positively formulated questions, which successfully detect when a disease impacts a person's subjective well-being. Minimum value 0, Maximum value 25. Higher score indicates better outcome.

    From enrollment to the end of treatment at 5 months.

Study Arms (2)

Intervention Group (MSCS)

EXPERIMENTAL

Will receive MSCS Survey every 3 weeks for a total of 6 administrations, an inspirational quote, and campus resources.

Behavioral: Mindful Self Care Survey (MSCS)

Control Group (Placebo)

PLACEBO COMPARATOR

Will receive two generic well-being questions, an inspirational quote, and campus resources at the same interval as the experimental group.

Other: Placebo

Interventions

Provided the Mindful Self Care Survey every 3 weeks for a total of 6 administrations.

Intervention Group (MSCS)
PlaceboOTHER

Will receive two generic well-being questions and an inspirational quote, and campus resources.

Control Group (Placebo)

Eligibility Criteria

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

You may qualify if:

  • + years old
  • Be enrolled in the MSOT or OTD programs at CSUDH and an active full-time student taking didactic courses.

You may not qualify if:

  • The investigators are excluding 17 and younger due to no one that young being in our program and them being minors.
  • The investigators are excluding part-time students due to the different stress experience that they would have compared to full-time students (due to the heavy academic load).
  • The investigators are excluding students from other OT programs due to complications with multiple IRBs and are piloting this study here first.
  • The investigators are excluding students from other graduate programs at CSUDH due to the unique program design and high number of units required in this cohorted program.
  • The investigators are excluding fieldwork 2 students because they are not taking the heavy didactic unit load and are off campus during these terms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSU Dominguez Hills

Carson, California, 90747, United States

Location

Study Officials

  • Lauren N Newhouse, OTD, OTR/L

    CSU Dominguez Hills

    PRINCIPAL INVESTIGATOR
  • Sheryl J Ryan, PhD, OTR/L

    CSU Dominguez Hills

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 29, 2026

Study Start

January 22, 2026

Primary Completion

July 29, 2026

Study Completion

July 29, 2026

Last Updated

September 29, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

1. This is not included in our IRB. 2. We are not intending to publish in an ICMJE Journal.

Locations