Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol
Primary Purpose
Adherence, Treatment, Job Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adherence self-efficacy-enhancing exercise
Med-Stress Student
Sponsored by
About this trial
This is an interventional prevention trial for Adherence, Treatment focused on measuring Job Stress, Adherence, Work engagement, Self-efficacy
Eligibility Criteria
Inclusion Criteria: must be at least 18 years old must be a medical student or intern who already has direct contact with patients There are no criteria for exclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student)
Internet intervention (Med-Stress Student)
Arm Description
Outcomes
Primary Outcome Measures
Adherence
Objective adherence will be based on quantifiable metrics, specifically the absolute number and percentage of completed exercises within the program. Subjective adherence will be evaluated with the following question that participants will respond to after each weekly set of exercises: "In your opinion, how accurately have you completed all tasks: have you followed the instructions, reflected on the questions, and responded to them exhaustively?".
Job Stress (Perceived Stress Scale; PSS-4)
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Job Stress (Perceived Stress Scale; PSS-4)
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Job Stress (Perceived Stress Scale; PSS-4)
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
A 9-item scale will be used to assess work engagement. The response range varies between 0 (never) to 6 (always), with a higher total score indicating a higher work engagement.
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
A 9-item variant of the scale will be used to assess work engagement. The response range varies between 0 (never) and 6 (always), with a higher total score signifying greater work engagement.
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
A 9-item variant of the scale will be used to assess work engagement. The response range varies between 0 (never) and 6 (always), with a higher total score signifying greater work engagement.
Secondary Outcome Measures
Full Information
NCT ID
NCT05881161
First Posted
May 18, 2023
Last Updated
May 30, 2023
Sponsor
University of Social Sciences and Humanities, Warsaw
Collaborators
Stockholm University
1. Study Identification
Unique Protocol Identification Number
NCT05881161
Brief Title
Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol
Official Title
Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Study Protocol Investigating Context-Specific Self-Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 8, 2024 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Social Sciences and Humanities, Warsaw
Collaborators
Stockholm University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low adherence in self-guided internet interventions might lead to worse outcomes. This randomized controlled trial aims to test whether adherence can be improved if self-efficacy regarding adherence to internet interventions is boosted before the intervention starts. It is expected that enhancing this specific type of self-efficacy will increase people's adherence and help them fully benefit from the intervention, namely experience lower job stress and higher work engagement.
Detailed Description
Low adherence can lead to poor outcomes in self-guided (i.e., self-administered) internet interventions that is psychological programs designed to improve mental health. One modifiable personal factor that may improve adherence is context-specific self-efficacy. In this two-arm randomized controlled trial, participants (medical students, N = 720) will undergo an internet intervention called Med-Stress Student designed to enhance resources such as self-efficacy to cope with stress and perceived social support. In the experimental group, Med-Stress Student will be preceded by an exercise designed to boost self-efficacy to adhere to this internet intervention. In the control condition, participants will only access Med-Stress Student. Conditions will be compared on adherence as well as on the intervention outcomes (i.e., job stress and work engagement) at posttest, and at six-month, and one-year follow-ups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Treatment, Job Stress
Keywords
Job Stress, Adherence, Work engagement, Self-efficacy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will not be informed about condition allocation. Both groups will undergo the same internet intervention (Med-Stress Student) but the experimental group will complete additional procedure at the start of the intervention.
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student)
Arm Type
Experimental
Arm Title
Internet intervention (Med-Stress Student)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Adherence self-efficacy-enhancing exercise
Intervention Description
This exercise aims to increase self-efficacy to adhere to an internet intervention. It consists of a video and two text-based tasks. The contents are grounded in Social-Cognitive Theory.
Intervention Type
Behavioral
Intervention Name(s)
Med-Stress Student
Intervention Description
Med-Stress Student is an intervention that spans over 4 weeks and aims to enhance resources to cope with job stress and promote well-being in medical students.
Primary Outcome Measure Information:
Title
Adherence
Description
Objective adherence will be based on quantifiable metrics, specifically the absolute number and percentage of completed exercises within the program. Subjective adherence will be evaluated with the following question that participants will respond to after each weekly set of exercises: "In your opinion, how accurately have you completed all tasks: have you followed the instructions, reflected on the questions, and responded to them exhaustively?".
Time Frame
Change from baseline: 4 weeks (posttest)
Title
Job Stress (Perceived Stress Scale; PSS-4)
Description
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Time Frame
Change from baseline: 4 weeks (posttest)
Title
Job Stress (Perceived Stress Scale; PSS-4)
Description
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Time Frame
Change from baseline: 6-month follow-up
Title
Job Stress (Perceived Stress Scale; PSS-4)
Description
The brief version of the scale consists of four items, rated on a scale ranging from 0 (never) to 4 (very often). It will be applied to measure job stress, with a higher total score indicating a heightened level of stress perception. The questionnaire's instructions have been modified to align with the occupational context.
Time Frame
Change from baseline: 1-year follow-up
Title
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Description
A 9-item scale will be used to assess work engagement. The response range varies between 0 (never) to 6 (always), with a higher total score indicating a higher work engagement.
Time Frame
Change from baseline: 4 weeks (posttest)
Title
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Description
A 9-item variant of the scale will be used to assess work engagement. The response range varies between 0 (never) and 6 (always), with a higher total score signifying greater work engagement.
Time Frame
Change from baseline: 6-month follow-up
Title
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Description
A 9-item variant of the scale will be used to assess work engagement. The response range varies between 0 (never) and 6 (always), with a higher total score signifying greater work engagement.
Time Frame
Change from baseline: 1-year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
must be at least 18 years old
must be a medical student or intern who already has direct contact with patients
There are no criteria for exclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewelina A Smoktunowicz, PhD
Phone
+48506354565
Email
esmoktunowicz@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
847061
Citation
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
Results Reference
background
PubMed Identifier
25881626
Citation
Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.
Results Reference
background
PubMed Identifier
33427674
Citation
Smoktunowicz E, Lesnierowska M, Carlbring P, Andersson G, Cieslak R. Resource-Based Internet Intervention (Med-Stress) to Improve Well-Being Among Medical Professionals: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 11;23(1):e21445. doi: 10.2196/21445.
Results Reference
background
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Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol
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