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Not yet recruitingNCT05881161Updated May 8, 2024

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

An interventional study of Adherence self-efficacy-enhancing exercise and Med-Stress Student in Adherence, Treatment and Job Stress, sponsored by University of Social Sciences and Humanities, Warsaw. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Social Sciences and Humanities, Warsaw · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
952
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Adherence, Treatment
  • Job Stress

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Keywords

  • Job Stress
  • Adherence
  • Work engagement
  • Self-efficacy
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In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's planned enrollment of 952 is above the median of 89 across 167 interventional studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

University of Social Sciences and Humanities, Warsaw is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
952 participants (estimated)

Study arms

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

    Behavioral: Adherence self-efficacy-enhancing exercise · Behavioral: Med-Stress Student

  • Active comparator
    Internet intervention (Med-Stress Student)

    Behavioral: Med-Stress Student

Interventions

  • BehavioralAdherence 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.

  • BehavioralMed-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.

06

What researchers measure

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?".

    Time frame: Change from baseline: 4 weeks (posttest)

Secondary outcomes

  1. 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.

    Time frame: Change from baseline: 4 weeks (posttest)

  2. 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.

    Time frame: Change from baseline: 1-year follow-up

  3. 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.

    Time frame: Change from baseline: 6-month follow-up

  4. 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.

    Time frame: Change from baseline: 6-month follow-up

  5. 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.

    Time frame: Change from baseline: 1-year follow-up

  6. 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.

    Time frame: Change from baseline: 4 weeks (posttest)

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 847061 ↗
  • 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. PubMed 25881626 ↗
  • 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. PubMed 33427674 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881161
Lead sponsor
University of Social Sciences and Humanities, Warsaw
Collaborators
Stockholm University
Responsible party
Ewelina Smoktunowicz (Principal Investigator; Head of StresLab Research Centre, University of Social Sciences and Humanities, Warsaw) — Principal investigator
First posted
May 31, 2023
Start date
Jan 8, 2025 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
May 8, 2024

Study contacts

Ewelina A Smoktunowicz, PhD
Contact
esmoktunowicz@gmail.com
+48506354565

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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