Mental Health WellnessNCT05779501
Efficacy of Internet-delivered Strengths Use Intervention
A study testing Internet-delivered strengths use intervention and Waiting-list in people with Mental Health Wellness and Professional Burnout, run by West University of Timisoara at 1 site in Romania.
Trial summary
The aim of the study will be to test the efficacy of a novel online-delivered gamification-based intervention for the identification, development, and use of strengths in the workplace. The program will be addressed to young employees and will have the aim of boosting their well-being and performance. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness, Professional Burnout
- What is being tested?
- Internet-delivered strengths use intervention and Waiting-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteRomania
- Study dates
- 15 Feb 2023to 15 Aug 2023
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not other than the age of the participants.
Who cannot join
- Lack of internet access during the period of the implementation of the program (prescreened during enrolment).
- Controlled variables:
- Participants levels of work engagement and work experience will be controlled for by stratified randomization. For each of the two factors we will created three strata (low level: lowest - 33rd percentile; moderate level: 34th - 66th percentile; high level: 67th percentile - highest), and the randomization will be applied for each stratum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of an Internet-delivered Strengths Use Intervention in Organizations A Waiting-list Randomized Trial
The aim of the study will be to test the efficacy of a novel online-delivered gamification-based intervention for the identification, development, and use of strengths in the workplace. The program will be addressed to young employees and will have the aim of boosting their well-being and performance.
- Conditions
- Mental Health Wellness, Professional Burnout
- Being tested
- Internet-delivered strengths use intervention, Waiting-list
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered strengths use interventionBehavioural
The online strengths use intervention program follows the theorized five stages of strengths use interventions: (1) preparation and commitment, (2) identification, (3) integration, (4) action, and (5) evaluation. To increase participant engagement and motivation, gamification components are embedded in several stages.
The intervention was previously tested through a feasibility and acceptability trial (NCT05474807).
The entire intervention will be delivered online via an LMS software solution.
Waiting-listBehavioural
The waiting-list arm will serve as the control group, filling in only the outcome measure at the same time as the intervention group participants.
After the intervention group finishes participating in the intervention, the waiting-list participants will benefit from the same internet-delivered strengths use program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental arm will receive the online strengths use intervention program over a period of 4 weeks, through an LMS software solution. Receives: Behavioral: Internet-delivered strengths use intervention |
| Waiting-list control group | Other | The waiting-list control arm will receive the same intervention immediately after the intervention group finishes and will have filled in the post-test outcomes measures. Receives: Behavioral: Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work engagement
Work engagement will be measured with the Utrecht Work Engagement Scale (UWES-9). It has 9 items that form three dimensions, each with 3 items: vigor (e.g., "At my work, I feel bursting with energy"), dedication (e.g., "I am enthusiastic about my job"), and absorption (e.g., "I am immersed in my work"). This measure uses a 7-point scale (0 =never, 6 = always). Higher scores represent higher work engagement.
Measured: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Psychological capital (PsyCap)
Psychological capital will be measured with the 12-item Psychological Capital Questionnaire. It has four subscales: hope ("At the moment, I feel quite fulfilled at work."), self-efficacy ("I feel confident presenting information to a group of colleagues."), resilience ("Usually, at work, I easily get over the stressful aspects."), and optimism ("I am optimistic about what will happen to me in the future regarding my job."). All 12-item are reported on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). Higher scores represent higher PsyCap.
Measured: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Strengths use
The Strengths Use subscale from the Strengths Use and Deficit Correction questionnaire (SUDCO). I has 6 items, rated on a 0 (almost never) to 6 (almost always) scale. A sample item is "I seek opportunities to do my work in a manner that best suits my strong points". Higher scores represent higher levels of strengths use.
Measured: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Strengths identification, use and development
A set of 18 items, rated on a 0 (almost never) to 6 (almost always) scale, was developed by the team of experts involved in this study. Higher scores represent higher levels of strengths use, identification, and development.
Measured: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Secondary outcomes (4)
Burnout
Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT). This questionnaire has four subscales: exhaustion (3 items; "At work, I feel mentally exhausted."), emotional impairment (3 items; "At work, I feel unable to control my emotions."), cognitive impairment (3 items; "At work, I have trouble staying focused.") and mental distance (3 items; "I struggle to find any enthusiasm for my work."). All items are scored on a 5-point scale ranging from 1(never) to 5 (always). Higher scores represent elevated symptoms of burnout.
Measured: Change from baseline to post-intervention (approximately 6 weeks).
Job satisfaction
Job satisfaction will be measured with the Michigan Organizational Assessment Questionnaire. The scale has three items with a response on a 7-point Likert scale (1 = total disagreement, 7 = total agreement). A sample item reads: "In general, I like working here.". Higher scores represent higher job satisfaction.
Measured: Change from baseline to post-intervention (approximately 6 weeks).
Job performance
Job performance will be assessed with a 7-item scale. Response options range on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). A sample item is "I adequately complete my assigned duties.". Higher scores represent higher performance.
Measured: Change from baseline to post-intervention (approximately 6 weeks).
Employability
Employability will be measured with the four-item Perceived Employability Scale. Each item is rated on a 5-point Likert scale (1 = totally disagree; 5 = totally agree). Higher scores represent higher levels of employability.
Measured: Change from baseline to post-intervention (approximately 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Feb 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies 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
- Sequential
- Model description
- Two-armed randomized trial with waiting-list control and pre-, mid-, and post-intervention measurements.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779501
- Sponsor's protocol ID
- MEGSIS S3 RCT
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Camman, C., Fichman, M., Jenkins, D., & Klesh, J. (1979). The Michigan Organizational Assessment Questionnaire(University of Michigan, Ann Arbor, Michigan).
Luthans, F. L., Avolio, B. J., & Avey, J. A. (2007). Psychological Capital Questionnaire (PsyCap) [Database record]. APAPsycTests. https://doi.org/10.1037/t06483-000
Schaufeli, W. B., Bakker, A. B., & Salanova, M. (2006). The measurement of work engagement with a short questionnaire: Across-national study. Educational and psychological measurement, 66(4), 701-716.https://doi.org/10.1177/0013164405282471
Schaufeli WB, Desart S, De Witte H. Burnout Assessment Tool (BAT)-Development, Validity, and Reliability. Int J Environ Res Public Health. 2020 Dec 18;17(24):9495. doi: 10.3390/ijerph17249495.
PubMed 33352940Tulbure BT, Rusu A, Sava FA, Salagean N, Farchione TJ. A Web-Based Transdiagnostic Intervention for Affective and Mood Disorders: Randomized Controlled Trial. JMIR Ment Health. 2018 May 24;5(2):e36. doi: 10.2196/mental.8901.
PubMed 29798831Van Woerkom, M., Mostert, K., Els, C., Bakker, A. B., De Beer, L., & Rothmann Jr, S. (2016). Strengths use and deficit correction in organizations: Development and validation of a questionnaire. European Journal of Work and Organizational Psychology, 25(6), 960-975. https://doi.org/10.1080/1359432X.2016.1193010
Watson D, Clark LA. Negative affectivity: the disposition to experience aversive emotional states. Psychol Bull. 1984 Nov;96(3):465-90. No abstract available.
PubMed 6393179Williams, L. J., & Anderson, S. E. (1991). Job satisfaction and organizational commitment as predictors of organizational citizenship and in-role behaviors. Journal of management, 17(3), 601-617. https://doi.org/10.1177/014920639101700305
Miglianico, M., Dubreuil, P., Miquelon, P., Bakker, A. B., & Martin-Krumm, C. (2020). Strength use in the workplace: aliterature review. Journal of Happiness Studies, 21(2), 737-764. https://doi.org/10.1007/s10902-019-00095-w
De Witte, H. (1992). Tussen optimisten en teruggetrokkenen. Een empirisch onderzoek naar het psychosociaal profiel vanlangdurig werklozen en deelnemers aan de Weer-Werkactie in Vlaanderen [Between optimists and withdrawns. An empiricalinvestigation of the psychosocial profile of longterm unemployed and participants of the Back-to-Work Program in Flanders].Leuven, Belgium: HIVA
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of an Internet-delivered Strengths Use Intervention in Organizations A Waiting-list Randomized Trial
- ClinicalTrials.gov ID
- NCT05779501
- Acronym / sponsor ID
- MEGSIS S3 RCT
- Conditions
- Mental Health Wellness, Professional Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 22 Mar 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.
The aim of the study will be to test the efficacy of a novel online-delivered gamification-based intervention for the identification, development, and use of strengths in the workplace. The program will be addressed to young employees and will have the aim of boosting their well-being and performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-armed randomized trial with waiting-list control and pre-, mid-, and post-intervention measurements.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Internet-delivered strengths use interventionThe experimental arm will receive the online strengths use intervention program over a period of 4 weeks, through an LMS software solution. |
| Waiting-list control group | Other | Behavioral: Waiting-listThe waiting-list control arm will receive the same intervention immediately after the intervention group finishes and will have filled in the post-test outcomes measures. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Not other than the age of the participants.
Key exclusion criteria (3 listed)
- Lack of internet access during the period of the implementation of the program (prescreened during enrolment).
- Participants levels of work engagement and work experience will be controlled for by stratified randomization. For each of the two factors we will created three strata (low level: lowest - 33rd percentile; moderate level: 34th - 66th percentile; high level: 67th percentile - highest), and the randomization will be applied for each stratum.
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 |
|---|---|---|
| Internet-delivered strengths use interventionThe online strengths use intervention program follows the theorized five stages of strengths use interventions: (1) preparation and commitment, (2) identification, (3) integration, (4) action, and (5) evaluation. To increase participant engagement and motivation, gamification components are embedded in several stages. The intervention was previously tested through a feasibility and acceptability trial (NCT05474807). The entire intervention will be delivered online via an LMS software solution. | Behavioural | Intervention group |
| Waiting-listThe waiting-list arm will serve as the control group, filling in only the outcome measure at the same time as the intervention group participants. After the intervention group finishes participating in the intervention, the waiting-list participants will benefit from the same internet-delivered strengths use program. | Behavioural | Waiting-list control group |
Primary outcome
Work engagement
Time frame: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Work engagement will be measured with the Utrecht Work Engagement Scale (UWES-9). It has 9 items that form three dimensions, each with 3 items: vigor (e.g., "At my work, I feel bursting with energy"), dedication (e.g., "I am enthusiastic about my job"), and absorption (e.g., "I am immersed in my work"). This measure uses a 7-point scale (0 =never, 6 = always). Higher scores represent higher work engagement.
Psychological capital (PsyCap)
Time frame: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
Psychological capital will be measured with the 12-item Psychological Capital Questionnaire. It has four subscales: hope ("At the moment, I feel quite fulfilled at work."), self-efficacy ("I feel confident presenting information to a group of colleagues."), resilience ("Usually, at work, I easily get over the stressful aspects."), and optimism ("I am optimistic about what will happen to me in the future regarding my job."). All 12-item are reported on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree). Higher scores represent higher PsyCap.
Strengths use
Time frame: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
The Strengths Use subscale from the Strengths Use and Deficit Correction questionnaire (SUDCO). I has 6 items, rated on a 0 (almost never) to 6 (almost always) scale. A sample item is "I seek opportunities to do my work in a manner that best suits my strong points". Higher scores represent higher levels of strengths use.
Strengths identification, use and development
Time frame: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).
A set of 18 items, rated on a 0 (almost never) to 6 (almost always) scale, was developed by the team of experts involved in this study. Higher scores represent higher levels of strengths use, identification, and development.
4 secondary outcomes
Burnout
Time frame: Change from baseline to post-intervention (approximately 6 weeks).
Job satisfaction
Time frame: Change from baseline to post-intervention (approximately 6 weeks).
Job performance
Time frame: Change from baseline to post-intervention (approximately 6 weeks).
Employability
Time frame: Change from baseline to post-intervention (approximately 6 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- BackgroundCamman, C., Fichman, M., Jenkins, D., & Klesh, J. (1979). The Michigan Organizational Assessment Questionnaire(University of Michigan, Ann Arbor, Michigan).
- BackgroundLuthans, F. L., Avolio, B. J., & Avey, J. A. (2007). Psychological Capital Questionnaire (PsyCap) [Database record]. APAPsycTests. https://doi.org/10.1037/t06483-000
- BackgroundSchaufeli, W. B., Bakker, A. B., & Salanova, M. (2006). The measurement of work engagement with a short questionnaire: Across-national study. Educational and psychological measurement, 66(4), 701-716.https://doi.org/10.1177/0013164405282471
- Background: PubMed 33352940Schaufeli WB, Desart S, De Witte H. Burnout Assessment Tool (BAT)-Development, Validity, and Reliability. Int J Environ Res Public Health. 2020 Dec 18;17(24):9495. doi: 10.3390/ijerph17249495.
- Background: PubMed 29798831Tulbure BT, Rusu A, Sava FA, Salagean N, Farchione TJ. A Web-Based Transdiagnostic Intervention for Affective and Mood Disorders: Randomized Controlled Trial. JMIR Ment Health. 2018 May 24;5(2):e36. doi: 10.2196/mental.8901.
- BackgroundVan Woerkom, M., Mostert, K., Els, C., Bakker, A. B., De Beer, L., & Rothmann Jr, S. (2016). Strengths use and deficit correction in organizations: Development and validation of a questionnaire. European Journal of Work and Organizational Psychology, 25(6), 960-975. https://doi.org/10.1080/1359432X.2016.1193010
- Background: PubMed 6393179Watson D, Clark LA. Negative affectivity: the disposition to experience aversive emotional states. Psychol Bull. 1984 Nov;96(3):465-90. No abstract available.
- BackgroundWilliams, L. J., & Anderson, S. E. (1991). Job satisfaction and organizational commitment as predictors of organizational citizenship and in-role behaviors. Journal of management, 17(3), 601-617. https://doi.org/10.1177/014920639101700305
- BackgroundMiglianico, M., Dubreuil, P., Miquelon, P., Bakker, A. B., & Martin-Krumm, C. (2020). Strength use in the workplace: aliterature review. Journal of Happiness Studies, 21(2), 737-764. https://doi.org/10.1007/s10902-019-00095-w
- BackgroundDe Witte, H. (1992). Tussen optimisten en teruggetrokkenen. Een empirisch onderzoek naar het psychosociaal profiel vanlangdurig werklozen en deelnemers aan de Weer-Werkactie in Vlaanderen [Between optimists and withdrawns. An empiricalinvestigation of the psychosocial profile of longterm unemployed and participants of the Back-to-Work Program in Flanders].Leuven, Belgium: HIVA
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered strengths use intervention and Waiting-list in people with Mental Health Wellness and Professional Burnout, run by West University of Timisoara at 1 site in Romania.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work engagement (time frame: Change from baseline to mid-intervention and post-intervention (approximately 3 weeks and 6 weeks).). The study lists 4 primary outcomes in all. 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 NCT05779501, which also lists 10 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 5 Oct 2023.