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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
University of Social Sciences and Humanities, Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adherence, Treatment focused on measuring Job Stress, Adherence, Work engagement, Self-efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 18, 2023
    Last Updated
    May 30, 2023
    Sponsor
    University of Social Sciences and Humanities, Warsaw
    Collaborators
    Stockholm University
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    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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