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ID
Source
Health condition
Individuals who experience work stress, defined as an effort-reward imbalance ratio of >1
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ambulatory measured heart rate variability, timepoint: post-intervention (i.e., 4-weeks)
Secondary outcome
• Ambulatory measured heart rate variability, timepoint: 2-weeks.
• Ambulatory measured heart rate, timepoint: 2-weeks, post-intervention.
• Implicit Positive and Negative Affect as measured with Implicit Positive and Negative Affect Test, timepoint: 2-weeks, post-intervention.
• Implicit stress as measured with the Implicit Association Test, timepoint: 2-weeks, post-intervention.
• Explicit positive and negative affect as measured with the four basic emotions, timepoint: 2-weeks, post-intervention.
• Five Facet Mindfulness Questionnaire score, timepoint: 2-weeks, post-intervention.
• Effort-Reward Imbalance score, timepoint: post-intervention
• Trait worry, as measured by Penn State Worry Questionnaire, timepoint: 2-weeks, post-intervention.
• Anxiety symptoms as measured by GAD-7, timepoint: 2-weeks, post-intervention.
• Depressive symptoms as measured by PHQ-9, timepoint: 2-weeks, post-intervention.
Background summary
Psychosocial stress is a widespread problem and a substantial co-determinant of organic disease, including cardiovascular disease (CVD). One of the most important stressors are work stressors, that increase CVD risk up to 3.6 times (Bosma, Peter, & Siegrist, 1998; Matthews & Gump, 2002) in a dose response fashion (Chandola et al., 2008), with follow-up times between 4-12 years. There is a general agreement that stressors exert their unhealthy effects in the long run via prolonged physiological stress responses (e.g., lower heart rate variability, prolonged blood pressure, excessive cortisol excretion). In recent years, a new hypothesis has been put forward stating that a large part of these prolonged physiological stress responses is due to implicit or unconscious stress (Brosschot, Verkuil, & Thayer, 2010). The best way to show that unconscious stress causes prolonged activity in real life, which is the main premise of this new theory, is to manipulate unconscious stress, in this case to decrease it, since the reverse would be unethical. To our knowledge however, no intervention exists that reduces unconscious stress. In this project we therefore want to study the effect of a smartphone-programmed mindfulness-based therapy on conscious (e.g., effort-reward imbalance) and unconscious (work) stress (i.e., Implicit Positive and Negative Affect Test and Implicit Association Test) and physiological stress (i.e., heart rate variability and heart rate) in daily life. More specifically, we expect that administering an evidence-based intervention (mindfulness) reduces the prolonged physiological stress response, and conscious as well as unconscious stress.
Study objective
•Participants in the experimental (i.e., mindfulness exercises) and control (i.e., emotion registration) condition will experience a decrease in prolonged cardiovascular activity, indicated by a increase in heart rate variability and an decrease in heart rate
•Participants in the experimental (i.e., mindfulness exercises) and control (i.e., emotion registration) condition will experience a decrease on the implicit negative affect scale of the Implicit Positive and Negative Affect Test and a decrease on implicit stress as measured by the Implicit Association Test.
•The decrease in both physiological and psychological complaints will be larger in the experimental and control condition, compared to the waitlist condition.
•The decrease in both physiological and psychological complaints will be larger in the experimental condition, compared to the control condition.
Study design
At the start of the intervention, after two weeks and after 4 weeks the cardiovascular activity and psychological measures will be completed.
Intervention
Experimental condition: Problem-solving techniques, worry postponement, mindfulness exercises
- Dose: daily, 5 times a day (between 9 AM – 11 PM)
- Duration: 4 weeks (29 days)
- Mode of administration: via an application on a smartphone
Active control condition: daily registration of basic emotions
- Dose: daily, 5 times a day (between 9 AM – 11 PM)
- Duration: 4 weeks (29 days)
- Mode of administration: via an application on a smartphone
Waitlist condition: No treatment
Inclusion criteria
Dutch speaking individuals who are employed, are 18 years or older, have an effort-reward imbalance ratio of >.89, and who have sufficient knowledge of how to work with a smartphone.
Exclusion criteria
Person is not currently employed, has a latex allergy, currently being treated for a psychological or psychiatric disorder, has or has had a cardiovascular disease, substance abuse, no current or recent reports of suicidal ideation, history or presence of severe psychological disorders.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4607 |
| NTR-old | NTR4758 |
| Other | Registration number of Ethics Commission of Leiden University : 2865487857 |