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

Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Study Protocol Investigating Context-Specific Self-Efficacy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adherence, Treatment; Job Stress
• Intervention / Treatment: Behavioral: Adherence self-efficacy-enhancing exercise; Behavioral: Med-Stress Student

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 Type: Interventional
• Enrollment (Estimated): 952
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ewelina A Smoktunowicz, PhD; Phone Number: +48506354565; Email: esmoktunowicz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?".	Change from baseline: 4 weeks (posttest)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline: 4 weeks (posttest)
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.	Change from baseline: 6-month follow-up
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.	Change from baseline: 1-year follow-up
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.	Change from baseline: 4 weeks (posttest)
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.	Change from baseline: 6-month follow-up
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.	Change from baseline: 1-year follow-up

Collaborators and Investigators

• Sponsor: University of Social Sciences and Humanities, Warsaw
• Collaborators: Stockholm University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 8, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Self-efficacy; Job Stress; Work engagement
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: Adherence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No