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

NCT ID: NCT05881161

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-01-31

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.

Conditions

Adherence, Treatment; Job Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student)

Group Type: EXPERIMENTAL

Adherence self-efficacy-enhancing exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Internet intervention (Med-Stress Student)

Group Type: ACTIVE_COMPARATOR

Med-Stress Student

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

University of Social Sciences and Humanities, Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Ewelina Smoktunowicz

Principal Investigator; Head of StresLab Research Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ewelina A Smoktunowicz, PhD

Role: CONTACT

esmoktunowicz@gmail.com

+48506354565

References

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.

Reference Type: BACKGROUND

PMID: 847061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25881626 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33427674 (View on PubMed)

Other Identifiers

Adherence

Identifier Type: -

Identifier Source: org_study_id