Testing a daily smartphone-delivered intervention in individuals with work stress|
|- candidate number||19585|
|- NTR Number||NTR4827|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2014|
|- Secondary IDs||5097802079 Registration number of Ethics Commission of Leiden University|
|- Public Title||Testing a daily smartphone-delivered intervention in individuals with work stress|
|- Scientific Title||Testing an intervention directed at reducing unconscious perseverative cognition|
|- hypothesis||• Participants in the experimental condition (i.e., mindfulness exercises) will experience a larger decrease on the implicit negative affect scale of the Implicit Positive and Negative Affect Test compared to the waitlist condition |
• Participants in the experimental condition will experience a larger decrease on implicit stress, as measured by the Implicit Association Test, compared to the waitlist condition.
|- Healt Condition(s) or Problem(s) studied||Stress, Work load|
|- Inclusion criteria||Dutch 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 criteria||Person is not currently employed, currently being treated for a psychological or psychiatric disorder, substance abuse, no current or recent reports of suicidal ideation, history or presence of severe psychological disorders|
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2014|
|- planned closingdate||30-jun-2016|
|- Target number of participants||120|
|- Interventions||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
Waitlist condition: no treatment
|- Primary outcome||•Implicit Positive and Negative Affect as measured with Implicit Positive and Negative Affect Test, time-point: post-intervention (i.e., 4-weeks).|
•Implicit stress as measured with the Implicit Association Test, time-point: post-intervention.
|- Secondary outcome||•Implicit Positive and Negative Affect as measured with Implicit Positive and Negative Affect Test, time-point: 2-weeks.|
•Implicit stress as measured with the Implicit Association Test, time-point: 2-weeks.
•Explicit positive and negative affect as measured with the four basic emotions, time-point: 2-weeks, post-intervention.
•Five Facet Mindfulness Questionnaire score, time-point: 2-weeks, post-intervention.
•Effort-Reward Imbalance score, time-point: post-intervention
•Trait worry, as measured by Penn State Worry Questionnaire, time-point: 2-weeks, post-intervention.
•Anxiety symptoms as measured by GAD-7, time-point: 2-weeks, post-intervention.
•Depressive symptoms as measured by PHQ-9, time-point: 2-weeks, post-intervention.
|- Timepoints||At the start of the intervention, after two weeks and after 4 weeks the psychological questionnaires and tasks will be completed.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| A. Versluis|
|- CONTACT for SCIENTIFIC QUERIES|| J.F. Brosschot|
|- Sponsor/Initiator ||Leiden University|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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) in daily life. More specifically, we expect that administering an evidence-based intervention (mindfulness) reduces conscious as well as unconscious stress. |
|- Main changes (audit trail)||29-Oct-2014: Studydesign reviewed by ethical committee Leiden University. No approval of METC required. - AB
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.
|- RECORD||1-okt-2014 - 19-jan-2016|
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