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

Adherence, Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05881161
• Other study ID #: Adherence
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 8, 2025
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: Ewelina A Smoktunowicz, PhD
• Phone: +48506354565
• Email: esmoktunowicz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 952
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Job Stress
• Occupational Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw	Stockholm University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)