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Testing daily smartphone-delivered interventions in individuals with workstress


- candidate number19356
- NTR NumberNTR4758
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-aug-2014
- Secondary IDs2865487857 Registration number of Ethics Commission of Leiden University
- Public TitleTesting daily smartphone-delivered interventions in individuals with workstress
- Scientific TitleTesting and comparing two interventions directed at reducing unconscious perseverative cognition and prolonged cardiovascular activity
- ACRONYM
- hypothesis•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.
- Healt Condition(s) or Problem(s) studiedStress, Work load
- Inclusion criteriaDutch speaking individuals who are employed, are 18 years or older, have an effort-reward imbalance ratio of >1, and who have sufficient knowledge of how to work with a smartphone.
- Exclusion criteriaPerson 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-sep-2014
- planned closingdate30-jun-2016
- Target number of participants180
- InterventionsExperimental 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
- Primary outcomeAmbulatory 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.
- TimepointsAt the start of the intervention, after two weeks and after 4 weeks the cardiovascular activity and psychological measures will be completed.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Versluis
- CONTACT for SCIENTIFIC QUERIES J.F. Brosschot
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryPsychosocial 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.
- Main changes (audit trail)24-aug-2015: CHANGE

Inclusion NEW:
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.
- RECORD27-aug-2014 - 19-jan-2016


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