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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02541240
Other study ID # RARMUoHP063015
Secondary ID
Status Completed
Phase N/A
First received August 31, 2015
Last updated May 10, 2016
Start date September 2015
Est. completion date January 2016

Study information

Verified date May 2016
Source University of Indianapolis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Current enrollment in Doctor of Physical Therapy program at either Indiana University or the University of Indianapolis

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Resilience Curriculum
The Resilience Curriculum consists of 4 modules, with one 2-hour module presented each week.

Locations

Country Name City State
United States Indiana University Purdue University Indianapolis Indianapolis Indiana
United States University of Indianapolis Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
University of Indianapolis

Country where clinical trial is conducted

United States, 

References & Publications (8)

Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. — View Citation

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in symptoms of Illness at 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 No
Primary 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. Baseline and 8 weeks No
Secondary 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, Baseline and 8 weeks No
Secondary 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. Baseline and 8 weeks No
Secondary 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. Baseline and 8 weeks No
Secondary 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. Baseline and 8 weeks No
Secondary 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. Baseline and 8 weeks No
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