Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol

Sponsor
University of Social Sciences and Humanities, Warsaw (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05881161
Collaborator
Stockholm University (Other)
720
2
12.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adherence self-efficacy-enhancing exercise
  • Behavioral: Med-Stress Student
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Primary Purpose:
Prevention
Official Title:
Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Study Protocol Investigating Context-Specific Self-Efficacy
Anticipated Study Start Date :
Jan 8, 2024
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student)

Behavioral: Adherence self-efficacy-enhancing exercise
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.

Behavioral: Med-Stress Student
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.

Active Comparator: Internet intervention (Med-Stress Student)

Behavioral: Med-Stress Student
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.

Outcome Measures

Primary Outcome Measures

  1. Adherence [Change from baseline: 4 weeks (posttest)]

    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?".

  2. Job Stress (Perceived Stress Scale; PSS-4) [Change from baseline: 4 weeks (posttest)]

    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.

  3. Job Stress (Perceived Stress Scale; PSS-4) [Change from baseline: 6-month follow-up]

    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.

  4. Job Stress (Perceived Stress Scale; PSS-4) [Change from baseline: 1-year follow-up]

    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.

  5. Work Engagement (Utrecht Work Engagement Scale; UWES-9) [Change from baseline: 4 weeks (posttest)]

    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.

  6. Work Engagement (Utrecht Work Engagement Scale; UWES-9) [Change from baseline: 6-month follow-up]

    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.

  7. Work Engagement (Utrecht Work Engagement Scale; UWES-9) [Change from baseline: 1-year follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Social Sciences and Humanities, Warsaw
  • Stockholm University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ewelina Smoktunowicz, Principal Investigator; Head of StresLab Research Centre, University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier:
NCT05881161
Other Study ID Numbers:
  • Adherence
First Posted:
May 31, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ewelina Smoktunowicz, Principal Investigator; Head of StresLab Research Centre, University of Social Sciences and Humanities, Warsaw
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023