NCT05881161

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
952

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 8, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 18, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

Job StressAdherenceWork engagementSelf-efficacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Job Stress (Perceived Stress Scale; PSS-4)

    Change from baseline: 4 weeks (posttest)

  • Job Stress (Perceived Stress Scale; PSS-4)

    Change from baseline: 1-year follow-up

  • Job Stress (Perceived Stress Scale; PSS-4)

    Change from baseline: 6-month follow-up

  • Work Engagement (Utrecht Work Engagement Scale; UWES-9)

    Change from baseline: 6-month follow-up

  • Work Engagement (Utrecht Work Engagement Scale; UWES-9)

    Change from baseline: 1-year follow-up

  • +1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Behavioral: Adherence self-efficacy-enhancing exerciseBehavioral: Med-Stress Student

Internet intervention (Med-Stress Student)

ACTIVE COMPARATOR
Behavioral: Med-Stress Student

Interventions

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.

Adherence self-efficacy-enhancing exercise followed by internet intervention (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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be at least 18 years old
  • must be a medical student or intern who already has direct contact with patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 847061BACKGROUND
  • 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.

    PMID: 25881626BACKGROUND
  • 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.

    PMID: 33427674BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and ComplianceOccupational Stress

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorOccupational DiseasesStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Ewelina A Smoktunowicz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Head of StresLab Research Centre

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 31, 2023

Study Start

January 8, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share