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Burnout, ProfessionalsNCT07583420

Development and Validation of Single-Session Digital Self-Guided Intervention to Prevent Burnout & Improve Wellness

A study testing Single-Session Intervention to Prevent Burnout & Enhance Psychological Wellness and Creative Writing in people with Burnout, Professionals and Wellness, Psychological, run by Saint Mary's University (Canada).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study develops and evaluates a self-guided digital single-session mental health intervention designed to reduce workplace burnout and enhance psychological well-being among employed Canadian adults. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Single-Session Intervention to Prevent Burnout & Enhance Psychological Wellness and Creative Writing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
Apr 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 19 years of age or older
  • Currently employed full-time
  • Reside in Canada
  • Not currently receiving treatment for a significant physical or mental health condition (e.g., ongoing psychotherapy or psychiatric care)
  • Sufficient English proficiency to understand the intervention materials and complete all study assessments

Who cannot join

  • Being under 19 years of age
  • Being unemployed, retired, or a student who is not concurrently employed
  • Residing outside Canada
  • Currently engaging in significant mental health treatment

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Development and Validation of an Evidence-Based, Self-Guided, Single Session Digital Intervention to Prevent Workplace Burnout & Enhance Psychological Wellness

This study develops and evaluates a self-guided digital single-session mental health intervention designed to reduce workplace burnout and enhance psychological well-being among employed Canadian adults. Workplace burnout, characterized by emotional exhaustion, cynicism, and reduced professional efficacy, affects approximately 40% of Canadian employees and leads to increased absenteeism, reduced productivity, and higher disability claims. Traditional mental health supports face barriers including long wait times, stigma, and accessibility issues. Single-Session Interventions (SSIs) offer a practical, cost-effective, and scalable complement to traditional services.

This is a randomized, double-arm, online trial. Participants are recruited via Prolific and randomly assigned (1:1) to either the experimental single-session burnout intervention or an active control condition focused on creative writing. The intervention focuses on its unique delivery of content focused on the evidence-based techniques, such as cognitive reframing, stress management, and behavioural strategies. The active control matches the intervention in length, structure, and user experience but omits the specific therapeutic ingredients.

Read more

All procedures are conducted entirely online through Qualtrics. Participants are compensated for their participation. Participants complete three sessions over approximately 30 days:

A baseline survey (about 10 minutes); A program session and immediate follow-up (about 40 minutes); And a 30-day follow-up survey (about 10 minutes).

Outcome measures include burnout (MBI-16), perceived stress (PSS-10), depressive symptoms (PHQ-8), anxiety (GAD-7), general health (GHQ-12), well-being (WHO-5), work engagement (UWES-3), readiness to change, perceived impact, and program feedback/acceptability. Main outcomes are examined using mixed-effects linear regression with a participant-level random intercept to test the group × time interaction across baseline, post-intervention, and follow-up.

Read the detailed description

This study is a randomized, double-arm, online clinical trial evaluating a self-guided, single-session digital intervention for burnout in employed adults. The research is conducted as part of a Ph.D. dissertation of Ehsan Etezad, PhD Candidate in Applied Organizational Psychology at Saint Mary's University under the supervision of Dr. John Fiset (faculty member at Saint Mary's University), with co-investigator Dr. Raghid Al-Hajj (Gulf University for Science and Technology, Kuwait).

The intervention was developed based on a comprehensive systematic review (Phase 1 of the dissertation) that screened 2,349 records and included 27 final studies examining self-guided digital mental health interventions. The design and content of the current intervention are grounded in the best practices identified through that systematic review.

Participants are recruited through Prolific, a third-party online survey panel designed for academic research. The research team posts a study listing that includes a brief description, estimated completion time, compensation, and general eligibility requirements. All recruitment occurs through the Prolific platform with no direct contact between investigators and potential participants.

Eligible participants are presented with an electronic informed consent form describing study procedures, expected time commitment, risks and benefits, confidentiality, voluntary participation, and contact information for the study team and local crisis resources. Consented participants complete a baseline assessment comprising demographic questions and validated outcome measures.

After baseline assessment, participants are randomized (1:1) to the experimental intervention or the active control. Allocation is concealed from participants until they begin their assigned module. The active control condition matches the intervention arm in length, structure, and user experience while intentionally omitting the specific therapeutic ingredients. The active control focuses on creative writing and is non-therapeutic, ensuring that any observed effects can be attributed to the intervention's active components rather than general factors such as time spent, format, attention, or digital engagement. After completing the T3 follow-up survey, all participants in the active control group receive access to the full intervention to ensure equitable access to the intervention's potential benefits.

Data collection occurs at three time points: T1 (baseline), T2 (immediately post-intervention), and T3 (30-day follow-up). The full outcome battery is completed at baseline and immediately post-intervention; follow-up assessments repeat all primary and secondary outcomes to evaluate maintenance of intervention effects.

The main outcomes (burnout, stress, depression, anxiety, wellness, engagement) are examined using mixed-effects linear regression with a participant-level random intercept to test the group × time interaction across baseline, post-intervention, and follow-up. The main comparison focuses on the change from baseline to immediate post-intervention between the two study arms.

Being tested
Single-Session Intervention to Prevent Burnout & Enhance Psychological Wellness, Creative Writing
Keywords
Workplace burnout, single-session intervention, self-guided digital intervention, psychological well-being, occupational stress, burnout prevention, employee mental health
Medical subject headings
Burnout, Psychological, Psychological Well-Being, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-Session Intervention to Prevent Burnout & Enhance Psychological WellnessBehavioural

    The intervention was developed based on a comprehensive systematic review (Phase 1 of the dissertation) that screened 2,349 records and included 27 final studies examining self-guided digital mental health interventions. The design and content of the current intervention are grounded in the best practices identified through that systematic review. Testimonials serve as the core delivery method for the intervention's "active ingredients." The systematic review showed that testimonials communicate information through narrative, enhance engagement and memory retention, leverage mechanisms such as mirror-neuron activation, reduce resistance, and promote behavioural activation. Each testimonial is purposefully designed to deliver specific therapeutic content, including cognitive reframing strategies to manage workplace stress, behavioural techniques for setting boundaries, and self-care practices for daily work routines.

  • Creative WritingBehavioural

    A matched-length, structurally parallel module focused on creative writing. Matches the intervention in layout, pacing, and aesthetic style but intentionally omits therapeutic ingredients.

Study groups in NCT07583420
Study groupRoleWhat they receive
Single-Session Burnout InterventionExperimentalA self-guided digital program that delivers evidence-based therapeutic content, including cognitive reframing, stress management, behavioural boundary-setting techniques, and self-care practices.
Receives: Behavioral: Single-Session Intervention to Prevent Burnout & Enhance Psychological Wellness
Creative WritingActive comparatorA matched-length, structurally parallel module focused on creative writing. Matches the intervention in layout, pacing, and aesthetic style but intentionally omits therapeutic ingredients.
Receives: Behavioral: Creative Writing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout - Maslach Burnout Inventory (MBI-16)

    The Maslach Burnout Inventory-General Survey (MBI-GS) is a 16-item self-report measure of occupational burnout, comprising three subscales: Exhaustion (5 items), Cynicism (5 items), and Professional Efficacy (6 items). Each item is rated on a 7-point frequency scale ranging from 1 ("never") to 7 ("every day").

    Subscale scores are calculated as the sum of items within each subscale. Possible ranges are: Exhaustion 5-35, Cynicism 5-35, and Professional Efficacy 6-42. Higher scores on the Exhaustion and Cynicism subscales indicate greater burnout (worse outcome). Higher scores on the Professional Efficacy subscale indicate greater perceived effectiveness (better outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  2. Perceived Stress - Perceived Stress Scale (PSS-10)

    The Perceived Stress Scale-10 (PSS-10; Cohen, Kamarck, \& Mermelstein, 1983) is a 10-item self-report measure of the degree to which situations in one's life are appraised as unpredictable, uncontrollable, and overloaded. Each item is rated on a 5-point scale from 0 ("never") to 5 ("very often"). Four positively-worded items are reverse-scored prior to summation. Total scores range from 0 to 50. Higher scores indicate greater perceived stress (worse outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  3. Depressive Symptoms - Patient Health Questionnaire (PHQ-8)

    The Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2009) is an 8-item self-report measure of depressive symptom severity over the past two weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"). The total score is the sum of all items. Total scores range from 0 to 24. Higher scores indicate greater depressive symptom severity (worse outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  4. Anxiety - Generalized Anxiety Disorder scale (GAD-7)

    The Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006) is a 7-item self-report measure of anxiety symptom severity over the past two weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"). The total score is the sum of all items. Total scores range from 0 to 21. Higher scores indicate greater anxiety symptom severity (worse outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  5. General Health - General Health Questionnaire (GHQ-12)

    The General Health Questionnaire-12 (GHQ-12; Goldberg et al., 1997) is a 12-item self-report screen for psychological distress and general mental health over the past few weeks. Each item is rated on a 4-point response scale (e.g., "more so than usual," "about the same as usual," "less so than usual," "much less than usual"). Items are scored using the Likert method (0-1-2-3 per item), with negatively-worded items reverse-coded so that higher item scores reflect worse health. Total scores range from 0 to 36. Higher scores indicate greater psychological distress and worse general mental health (worse outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  6. Well-Being - WHO Well-Being Index (WHO-5)

    The World Health Organization-Five Well-Being Index (WHO-5; WHO, 1998) is a 5-item self-report measure of subjective psychological well-being over the past two weeks. Each item is rated on a 6-point scale from 0 ("at no time") to 5 ("all of the time"). The raw total score (0-25) is multiplied by 4 to yield a percentage-based score. Final scores range from 0 to 100. Higher scores indicate greater subjective well-being (better outcome). A score below 50 is conventionally considered to indicate reduced well-being.

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

  7. Work Engagement - Utrecht Work Engagement Scale (UWES-3)

    The Utrecht Work Engagement Scale-3 (UWES-3; Schaufeli, Shimazu, Hakanen, Salanova, \& De Witte, 2019) is a 3-item ultra-short self-report measure of work engagement, with one item each for vigor, dedication, and absorption. Each item is rated on a 7-point frequency scale from 0 ("never") to 6 ("always / every day"). The total score is computed as the mean of the three items. The total score ranges from 0 to 6. Higher scores indicate greater work engagement (better outcome).

    Measured: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583420
Sponsor's protocol ID
26-088
Status last verified
May 2026
First submitted
27 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Single-Session Intervention to Prevent Burnout & Enhance Psychological Wellness and Creative Writing in people with Burnout, Professionals and Wellness, Psychological, run by Saint Mary's University (Canada).

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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ehsan Etezad (902-420-5400, ehsan@ehsanetezad.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout - Maslach Burnout Inventory (MBI-16) (time frame: T1 - Baseline Pre-Intervention (Day 1); T2 - Post-Intervention Assessment (Day 2); T3 - Follow-up Assessment (Day 30)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 May 2026.

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