- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06773468
Evaluating Knowledge Mobilization Vehicles
Evaluating Knowledge Mobilization for Stress Management in University Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
University students have been reporting high levels of stress, which have been found to negatively impact their academic performance and overall well-being. Given these elevated levels of stress, a large number of students report using unhealthy coping behaviours such as alcohol and drug use or risky sexual behaviours to cope with daily stressors. High levels of stress can be harmful to students' quality of life and well-being (both physical and mental), as well as elevated stress over an extended period can hinder academic performance. To address the overwhelming demands for wellness services, online approaches to delivering stress management and well-being supports are being used on campuses as supplemental means of promoting student stress management, coping capacity, and well-being.
Growing research on the barriers associated with help-seeking and changes due to the pandemic have spurred a shift from in-person supports to online self-directed modalities. Evidence from research measuring the acceptability of digital mental health interventions in university students suggests that students rate these interventions with moderate to high acceptability, but students report concerns around the use of certain digital modalities such as privacy, credibility, and lack of guidance on how to get started and use the interventions. Research has demonstrated how these types of online support can be effective at enhancing university student well-being and decreasing stress. For example, an umbrella review of systematic reviews and meta-analyses to synthesize the literature on digital mental health interventions in higher education found that most interventions were effective at decreasing depression symptoms, anxiety, and stress in this context. Specifically, skills-training and cognitive behavioral therapy (CBT)-based interventions were found to be effective. However, it is important to highlight that the authors found that the effectiveness depended on the modality or delivery format of the intervention. Although there is evidence for their individual effectiveness when compared to inactive control groups, it is crucial to have a better theoretical understanding of their relative effectiveness to one another to make research-informed decisions in selecting instructional approaches to support students' coping capacity in higher education.
Therefore, the overarching objective of the current study is to investigate how stress management knowledge can be effectively put into action within the university context by comparing different modalities. The study seeks to investigate differences in response to self-directed vs. non self-directed approaches to sharing stress management knowledge with students against a control group, specifically in terms of acceptability and change over time on wellness outcomes while accounting for the role of strategy use frequency. Specifically, the first objective (1.1) was to compare and evaluate self-directed, non self-directed, and an inactive control group by assessing effectiveness as demonstrated in changes (pre/post/follow-up) on wellness outcomes (i.e., perceived stress, coping capacity, mindfulness, coping self-efficacy, and well-being), while (1.2) examining the role of strategy use frequency. The second objective (2) is to further examine specific differences between commonly used knowledge mobilization modalities for stress management strategies (workshop, video, infographic) and an inactive control group by assessing (2.1) acceptability (i.e., likelihood of use, satisfaction) and (2.2) effectiveness as demonstrated in changes (pre/post/follow-up) on the same wellness outcomes while (2.3) examining the role of strategy use frequency.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada
- McGill University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current university student
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Workshop
30-minute online stress management workshop providing psychoeducation and strategy practice with links to strategies shared at the end
|
These different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of strategies.
Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support.
|
|
Experimental: Video
a short 10-minute stress management video providing psychoeducation and strategy practice with links to strategies shared at the end
|
These different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of strategies.
Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support.
|
|
Experimental: Infographic
a brief 3-page stress management interactive infographic (i.e., with psychoeducation and embedded links for strategy practice)
|
These different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of strategies.
Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support.
|
|
No Intervention: Inactive control
Waitlist inactive control that will receive all stress management materials at the end of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stress
Time Frame: Week 0, 4, and 7
|
The Perceived Stress Scale (PSS) is a widely used self-report measure of individuals' perception of stress.
This measure contains 10 items in which participants indicate their experience of stress on a 5-point Likert scale (0 = never to 4 = very often).
Items were adapted to reflect experiences during the past week and include statements such as "In the past week, how often have you felt difficulties were piling up so high that you could not overcome them?"
Ratings were averaged across items such that higher scores represented greater perceived stress.
The PSS has good reliability (Cronbach's α = .89),
construct validity, and predictive validity with reports of psychological and physical symptoms.
|
Week 0, 4, and 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Satisfaction
Time Frame: Week 4 and 7
|
The Response to Training is a researcher-developed questionnaire assessing participants' satisfaction with the intervention content and delivery.
The questions were delivered according to the three levels of Kirkpatrick's New World Model (Kirkpatrick & Kirkpatrick, 2016) as follows: (1) student viewers' response (i.e., satisfaction, engagement, relevance); (2) learning (i.e., knowledge, skills, attitude, confidence, commitment); (3) use of skills (i.e., willingness to use, frequency of use).
All items are scored on a 6-point Likert-scales except for the strategy use item described below, where higher scores represent a better response to training.
Sample items include "I would recommend the stress management resource to other university students" or "I am planning to use the strategies in the future..."
|
Week 4 and 7
|
|
Change in coping capacity
Time Frame: Week 0, 4, and 7
|
The Coping Index (CI; (Stallman, 2017), a 20-item measure of engagement with healthy and unhealthy coping strategies that are aligned with the health theory of coping framework (Stallman, 2020).
The measure consists of items that list common healthy and unhealthy coping behaviours such as 'talk things over with family or friends', 'do relaxing activities', or 'have negative self-talk'.
Participants are asked to indicate how often they engage in each behaviour listed when they feel stressed or distressed on a 4-point Likert scale (0 = I don't do this at all to 3 = I do this most of the time).
This measure has been found to have satisfactory test-retest reliability with alpha = 0.71 (Stallman, 2019).
|
Week 0, 4, and 7
|
|
Change in mindfulness
Time Frame: Week 0, 4, and 7
|
The Five Facets of Mindfulness Questionnaire short form (FFMQ-15; (Baer et al., 2006, 2008) which is a 15-item self-report measure consisting of five subscales each assessing a specific facet of dispositional mindfulness: acting with awareness, describing, observing, non-reactivity, and non-judgmental acceptance.
Items include "I'm good at finding words to describe my feelings" and "When I have distressing thoughts or images, I am able just to notice them without reacting".
Participants rate their responses on a 5-point Likert scale (1 = never or very rarely true to 5 = very often or always true).
The FFMQ-15 has good internal consistency with Cronbach alphas ranging from .64 to .83, as well as convergent validity (Gu et al., 2016).
Higher scores on the FFMQ-15 represent higher mindfulness.
|
Week 0, 4, and 7
|
|
Change in coping self-efficacy
Time Frame: Week 0, 4, and 7
|
The Coping Self-Efficacy Scale (CSES; Chesney et al., 2006) which is a measure of one's confidence in effectively engaging in coping behaviors in the face of challenges.
This measure contains 26 items in which participants indicate confidence in their coping strategies when it comes to handling challenges and stressors on an 11-point Likert scale (0 = cannot do at all to 10 = certain can do).
The CSES states, "When things aren't going well for you, or when you're having problems, how confident or certain are you that you can do the following:" and include statements such as "find solutions to your most difficult problems" and "see things from the other person's point of view during a heated argument."
Higher scores on the CSES represent higher coping-self efficacy.
|
Week 0, 4, and 7
|
|
Change in well-being
Time Frame: Week 0, 4, and 7
|
The Warwick-Edinburg Mental Well-Being Scale (WEMWBS; Tennant et al., 2007), which is a measure of positive mental health and consists of 14 positively worded items.
Participants are asked to rate statements such as "I've been feeling good about yourself" on a 5-point Likert scale according to their experience over the past 2 weeks (1= none of the time; 5= all of the time).
The WEMWBS has demonstrated good internal consistency in student (α = .89)
and general population samples (α = .91)
and was found to be psychometrically robust in validation studies (Stewart-Brown et al., 2011; Tennant et al., 2007).
|
Week 0, 4, and 7
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lattie EG, Adkins EC, Winquist N, Stiles-Shields C, Wafford QE, Graham AK. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. J Med Internet Res. 2019 Jul 22;21(7):e12869. doi: 10.2196/12869.
- Harrer M, Adam SH, Baumeister H, Cuijpers P, Karyotaki E, Auerbach RP, Kessler RC, Bruffaerts R, Berking M, Ebert DD. Internet interventions for mental health in university students: A systematic review and meta-analysis. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1759. doi: 10.1002/mpr.1759. Epub 2018 Dec 26.
- Harith S, Backhaus I, Mohbin N, Ngo HT, Khoo S. Effectiveness of digital mental health interventions for university students: an umbrella review. PeerJ. 2022 Mar 31;10:e13111. doi: 10.7717/peerj.13111. eCollection 2022.
- Bourdon JL, Moore AA, Long EC, Kendler KS, Dick DM. The relationship between on-campus service utilization and common mental health concerns in undergraduate college students. Psychol Serv. 2020 Feb;17(1):118-126. doi: 10.1037/ser0000296. Epub 2018 Oct 8.
- LaMontagne LG, Doty JL, Diehl DC, Nesbit TS, Gage NA, Kumbkarni N, Leon SP. Acceptability, usage, and efficacy of mindfulness apps for college student mental health: A systematic review and meta-analysis of RCTs. J Affect Disord. 2024 Dec 15;367:951-971. doi: 10.1016/j.jad.2024.09.014. Epub 2024 Sep 10.
- Kern A, Hong V, Song J, Lipson SK, Eisenberg D. Mental health apps in a college setting: openness, usage, and attitudes. Mhealth. 2018 Jun 30;4:20. doi: 10.21037/mhealth.2018.06.01. eCollection 2018.
- Frazier P, Gabriel A, Merians A, Lust K. Understanding stress as an impediment to academic performance. J Am Coll Health. 2019 Aug-Sep;67(6):562-570. doi: 10.1080/07448481.2018.1499649. Epub 2018 Oct 4.
- Metzger IW, Blevins C, Calhoun CD, Ritchwood TD, Gilmore AK, Stewart R, Bountress KE. An examination of the impact of maladaptive coping on the association between stressor type and alcohol use in college. J Am Coll Health. 2017 Nov-Dec;65(8):534-541. doi: 10.1080/07448481.2017.1351445. Epub 2017 Jul 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-11-006
- SSHRC 430-2022-00172 (Other Grant/Funding Number: Social Sciences and Humanities Research Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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