- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541240
Effects of an Intervention to Enhance Resilience in Physical Therapy Students
Health professional students experience high levels of psychological stress. Individuals with higher levels of resilience are better equipped to handle stress. The purpose of this study is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience, coping, protective factors, and symptomatology on students enrolled in a doctor of physical therapy (DPT) program.
Hypothesis: The curriculum will decrease stress levels, increase resilience, coping flexibility, protective factors (optimism, positive affect, and social support), and reduce symptomatology (negative affect, illness). Research on stress and its consequences experienced by physical therapy students in particular is limited. If the results of this study support this hypothesis, it may establish the benefit of adding a resilience component to the curriculum for students of physical therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study involves curriculum development and evaluation by randomized controlled trial. Participants will be randomized to the intervention group to receive a Resilience Curriculum or to a wait-list control group to receive a condensed version of the curriculum following the post-intervention assessments.
Pre- and post-intervention assessments will be administered to both groups, with baseline assessments administered in the first two weeks of the semester. The assessments will include measures of stress levels, levels of resilience, coping flexibility, optimism, positive and negative emotions, social support, and symptoms of illness. The intervention, the presentation of a resilience curriculum, will be delivered to the intervention group during the week following the baseline assessments and it will last for four weeks.
The resilience curriculum will provide education for participants about methods to increase protective factors against stress, the use of effective coping strategies, and the importance of accessing social support, with the goal of better managing stress and enhancing resilience. The intervention will include a didactic component, skills-building training, and homework exercises to encourage the application of the skills. The curriculum will be delivered in four 2-hour modules, with one module delivered each week. The follow-up assessments will occur after midterm examinations are concluded. An abbreviated curriculum which will last approximately two hours will be delivered to the wait-list control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46227
- University of Indianapolis
-
Indianapolis, Indiana, United States, 46202
- Indiana University Purdue University Indianapolis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current enrollment in Doctor of Physical Therapy program at either Indiana University or the University of Indianapolis
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resilience Curriculum
The intervention is exposure to an 8-hour Resilience Curriculum.
It will provide education for participants about methods to increase protective factors against stress, the use of effective coping strategies, and the importance of accessing social support, with the goal of better managing stress and enhancing resilience.
The curriculum will include a didactic component, skills-building training, and homework exercises to encourage the application of the skills.
|
The Resilience Curriculum consists of 4 modules, with one 2-hour module presented each week.
|
|
No Intervention: No Resilience Curriculum
The Waitlist Control group will receive no exposure to the Resilience Curriculum.
After the final data is collected, this group will be offered the opportunity to attend a condensed 2-hour version of the curriculum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in psychological resilience at 8 weeks
Time Frame: Baseline and 8 weeks
|
The 25-item Connor-Davidson Resilience Scale measures a variety of constructs of resilience including hardiness, personal competence, social bonds, patience, and spiritual influences.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in perceived psychological stress at 8 weeks
Time Frame: Baseline and 8 weeks
|
The 10-item Perceived Stress Scale was created to assess the perception of stress in the previous month,
|
Baseline and 8 weeks
|
|
Change from baseline in coping flexibility at 8 weeks
Time Frame: Baseline and 8 weeks
|
The Coping Flexibility Scale is a 10-item tool to measure the ability of an individual to effectively modify coping behavior.
|
Baseline and 8 weeks
|
|
Change from baseline in optimism at 8 weeks
Time Frame: Baseline and 8 weeks
|
The Revised Life Orientation Test is a 10-item scale designed to measure optimism in an individual.
|
Baseline and 8 weeks
|
|
Change from baseline in positive and negative emotions at 8 weeks
Time Frame: Baseline and 8 weeks
|
The 20-item Modified Differential Emotion Scale, an adaptation of the original Differential Emotion Scale, measures positive and negative emotions that an individual has experienced in the previous 2 weeks.
|
Baseline and 8 weeks
|
|
Change from baseline in social support at 8 weeks
Time Frame: Baseline and 8 weeks
|
The Social Provisions Scale is a 24-item assessment of six areas of social relationships (guidance, reliable alliance, attachment, social integration, reassurance of worth, and opportunity for nurturance) used to measure perceived social support.
|
Baseline and 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in symptoms of Illness at 8 weeks
Time Frame: Baseline and 8 weeks
|
The Symptoms of Illness Checklist is a 33-item tool designed to measure the number, frequency, and severity of physical symptoms experienced in the previous two-week period.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne M Mejia-Downs, PT, MPH, University of Indianapolis
Publications and helpful links
General Publications
- Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- 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.
- Tugade MM, Fredrickson BL. Resilient individuals use positive emotions to bounce back from negative emotional experiences. J Pers Soc Psychol. 2004 Feb;86(2):320-33. doi: 10.1037/0022-3514.86.2.320.
- O'Leary VE, Ickovics JR. Resilience and thriving in response to challenge: an opportunity for a paradigm shift in women's health. Womens Health. 1995 Summer;1(2):121-42.
- Walsh JM, Feeney C, Hussey J, Donnellan C. Sources of stress and psychological morbidity among undergraduate physiotherapy students. Physiotherapy. 2010 Sep;96(3):206-12. doi: 10.1016/j.physio.2010.01.005. Epub 2010 Apr 8.
- Jacob T, Itzchak EB, Raz O. Stress among healthcare students--a cross disciplinary perspective. Physiother Theory Pract. 2013 Jul;29(5):401-12. doi: 10.3109/09593985.2012.734011. Epub 2012 Oct 24.
- Steinhardt M, Dolbier C. Evaluation of a resilience intervention to enhance coping strategies and protective factors and decrease symptomatology. J Am Coll Health. 2008 Jan-Feb;56(4):445-53. doi: 10.3200/JACH.56.44.445-454.
- McAllister M, McKinnon J. The importance of teaching and learning resilience in the health disciplines: a critical review of the literature. Nurse Educ Today. 2009 May;29(4):371-9. doi: 10.1016/j.nedt.2008.10.011. Epub 2008 Dec 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RARMUoHP063015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Stress
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
Istanbul Medeniyet UniversityIstanbul Provincial Directorate of Family and Social ServicesNot yet recruitingBurnout, Professional | Stress, Psychological | Psychological Distress | Stress, Psychological, OccupationalTurkey (Türkiye)
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
New York State Psychiatric InstituteJohnson & JohnsonCompletedPsychological Stress in PregnancyUnited States
-
Hacettepe UniversityCompletedStressTurkey (Türkiye)
-
Baylor UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Psychological StressUnited States
-
Örebro University, SwedenCompletedPsychological Stress Due to SkydivingSweden
-
Universität Duisburg-EssenRecruitingStress | Burnout | Burnout Syndrome | Stress ResilienceGermany
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Amrita Vishwa VidyapeethamAmrita Viswa VidyapeethamCompletedCovid Related Psychological StressIndia
Clinical Trials on Resilience Curriculum
-
Göteborg UniversityIOGT-NTO's Junior AssociationCompletedResilience
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH)Completed
-
CorStoneDavid and Lucile Packard FoundationActive, not recruitingMental Health Wellness 1 | Resilience, PsychologicalIndia
-
University of California, IrvineNational Institute on Drug Abuse (NIDA); University of California, Los Angeles and other collaboratorsRecruitingFamily Functioning | Adverse Childhood ExperiencesUnited States
-
Penn State UniversityNational Institute on Drug Abuse (NIDA); Ohio State UniversityCompleted
-
University of ChicagoActive, not recruitingLanguage Environments of Children of Low-socioeconomic StatusUnited States
-
Johns Hopkins Bloomberg School of Public HealthFogarty International Center of the National Institute of HealthWithdrawnSelf Efficacy | Behavior ChangePakistan
-
University Hospitals Cleveland Medical CenterAmerican Academy of Pediatrics; Mt. Sinai Health Care FoundationCompleted
-
Brigham and Women's HospitalJohns Hopkins University; Massachusetts General Hospital; Washington University... and other collaboratorsCompletedResident Knowledge and Attitudes Regarding Cross-cultural Care | Interpersonal and Communication Skills in Patient-clinician Encounters | Patient-reported Satisfaction With Resident Physicians Involved in Their Care | Patients' Clinical Health Outcomes After SurgeryUnited States
-
Weill Medical College of Cornell UniversityCompletedPediatric Residents Rotating in Pediatric OncologyUnited States