Adherence, TreatmentNCT05881161
Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol
A study testing Adherence self-efficacy-enhancing exercise and Med-Stress Student in people with Adherence, Treatment and Job Stress, run by University of Social Sciences and Humanities, Warsaw.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence, Treatment, Job Stress
- What is being tested?
- Adherence self-efficacy-enhancing exercise and Med-Stress Student
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Adherence, Treatment, Job Stress
- Being tested
- Adherence self-efficacy-enhancing exercise, Med-Stress Student
- Keywords
- Job Stress, Adherence, Work engagement, Self-efficacy
- Medical subject headings
- Treatment Adherence and Compliance, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence self-efficacy-enhancing exerciseBehavioural
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 StudentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student) | Experimental | Not described Receives: Behavioral: Adherence self-efficacy-enhancing exercise; Behavioral: Med-Stress Student |
| Internet intervention (Med-Stress Student) | Active comparator | Not described Receives: Behavioral: Med-Stress Student |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?".
Measured: Change from baseline: 4 weeks (posttest)
Secondary outcomes (6)
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.
Measured: 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.
Measured: Change from baseline: 1-year 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline: 4 weeks (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start8 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 952 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Principal investigator, Ewelina Smoktunowicz, University of Social Sciences and Humanities, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881161
- Sponsor's protocol ID
- Adherence
- Status last verified
- May 2024
- First submitted
- 18 May 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 847061Karyotaki 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 25881626Smoktunowicz 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Study Protocol Investigating Context-Specific Self-Efficacy
- ClinicalTrials.gov ID
- NCT05881161
- Acronym / sponsor ID
- Adherence
- Conditions
- Adherence, Treatment, Job Stress
- Keywords
- Job Stress, Adherence, Work engagement, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 952 participants (estimated)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student) | Experimental | Behavioral: Adherence self-efficacy-enhancing exercise, Behavioral: Med-Stress Student |
| Internet intervention (Med-Stress Student) | Active comparator | Behavioral: Med-Stress Student |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence self-efficacy-enhancing exerciseThis 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. | Behavioural | Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student) |
| Med-Stress StudentMed-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. | Behavioural | Adherence self-efficacy-enhancing exercise followed by internet intervention (Med-Stress Student), Internet intervention (Med-Stress Student) |
Primary outcome
Adherence
Time frame: Change from baseline: 4 weeks (posttest)
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?".
6 secondary outcomes
Job Stress (Perceived Stress Scale; PSS-4)
Time frame: Change from baseline: 4 weeks (posttest)
Job Stress (Perceived Stress Scale; PSS-4)
Time frame: Change from baseline: 1-year follow-up
Job Stress (Perceived Stress Scale; PSS-4)
Time frame: Change from baseline: 6-month follow-up
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Time frame: Change from baseline: 6-month follow-up
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Time frame: Change from baseline: 1-year follow-up
Work Engagement (Utrecht Work Engagement Scale; UWES-9)
Time frame: Change from baseline: 4 weeks (posttest)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 847061Bandura 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.
- Background: PubMed 25881626Karyotaki 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.
- Background: PubMed 33427674Smoktunowicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence self-efficacy-enhancing exercise and Med-Stress Student in people with Adherence, Treatment and Job Stress, run by University of Social Sciences and Humanities, Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ewelina A Smoktunowicz, PhD (+48506354565, esmoktunowicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Change from baseline: 4 weeks (posttest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881161, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.