Psychological StressNCT02541240
Effects of an Intervention to Enhance Resilience in Physical Therapy Students
A study testing Resilience Curriculum in people with Psychological Stress, run by University of Indianapolis at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Resilience Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Current enrollment in Doctor of Physical Therapy program at either Indiana University or the University of Indianapolis
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Purdue University Indianapolis
Indianapolis, Indiana, 46202
University of Indianapolis
Indianapolis, Indiana, 46227
About this study
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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- Resilience Curriculum
- Keywords
- resilience, optimism, stress, coping, curriculum
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience CurriculumOther
The Resilience Curriculum consists of 4 modules, with one 2-hour module presented each week.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Curriculum | Experimental | 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. Receives: Other: Resilience Curriculum |
| No Resilience Curriculum | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in psychological resilience at 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.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change from baseline in perceived psychological stress at 8 weeks
The 10-item Perceived Stress Scale was created to assess the perception of stress in the previous month,
Measured: Baseline and 8 weeks
Change from baseline in coping flexibility at 8 weeks
The Coping Flexibility Scale is a 10-item tool to measure the ability of an individual to effectively modify coping behavior.
Measured: Baseline and 8 weeks
Change from baseline in optimism at 8 weeks
The Revised Life Orientation Test is a 10-item scale designed to measure optimism in an individual.
Measured: Baseline and 8 weeks
Change from baseline in positive and negative emotions at 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.
Measured: Baseline and 8 weeks
Change from baseline in social support at 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Mejia-Downs, University of Indianapolis
- Investigators
- Anne M Mejia-Downs, PT, MPH, Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541240
- Sponsor's protocol ID
- RARMUoHP063015
- Status last verified
- May 2016
- First submitted
- 31 Aug 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data will not be shared.
Publications
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.
PubMed 9373376Walsh 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.
PubMed 20674652Jacob 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.
PubMed 23094641Carver 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.
PubMed 2926629Tugade 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.
PubMed 14769087Steinhardt 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.
PubMed 18316290McAllister 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.
PubMed 19056153Connor 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.
PubMed 12964174
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intervention to Enhance Resilience in Physical Therapy Students
- ClinicalTrials.gov ID
- NCT02541240
- Acronym / sponsor ID
- RARMUoHP063015
- Conditions
- Psychological Stress
- Keywords
- resilience, optimism, stress, coping, curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience Curriculum | Experimental | Other: Resilience CurriculumThe 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. |
| No Resilience Curriculum | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Current enrollment in Doctor of Physical Therapy program at either Indiana University or the University of Indianapolis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Resilience CurriculumThe Resilience Curriculum consists of 4 modules, with one 2-hour module presented each week. | Other | Resilience Curriculum |
Primary outcome
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.
5 secondary outcomes
Change from baseline in perceived psychological stress at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline in coping flexibility at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline in optimism at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline in positive and negative emotions at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline in social support at 8 weeks
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 9373376O'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.
- Background: PubMed 20674652Walsh 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.
- Background: PubMed 23094641Jacob 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.
- Background: PubMed 2926629Carver 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.
- Background: PubMed 14769087Tugade 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.
- Background: PubMed 18316290Steinhardt 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.
- Background: PubMed 19056153McAllister 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.
- Background: PubMed 12964174Connor 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.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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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. This study is not recruiting at the moment.
Anne M Mejia-Downs, PT, MPH principal investigator
University of Indianapolis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Curriculum in people with Psychological Stress, run by University of Indianapolis at 2 sites 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 1 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: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in psychological resilience at 8 weeks (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541240, which also lists 8 linked publications.
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 11 May 2016.