Clinical trial NCT05557266: Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Stress and Biological Measures
Official title: Differential Effectiveness of Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress, Inmunoglobuline A, and Cortisol. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Health Wellness
Keywords: mindfulness
physical exercise
meditation
mental health
stress
recovery
inmunoglobulin A
cortisol
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
name: Ministerio de Ciencia e Innovación, Spain
First posted: 2022-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1,3, and 6 months.
Primary purpose: TREATMENT

Brief summary: The present study aims to compare the differential effects of mindfulness meditation (MBI) and physical exercise (PE) on different stress and health variables (self-report means and IgA and cortisol levels). A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1, 3 and 6 months that would be developed among the Guardia Civil (Spanish military police) office staff.

Detailed description: Recovery from fatigue and daily work stress involves mentally disconnecting from work. To achieve this disconnection (or psychological detachment), research has shown that engaging in a variety of interesting and motivating activities for individuals after the workday allows them to achieve this disconnected state of mind and, consequently, facilitates recovery from work. Previous research has shown that two of the most effective recovery activities are physical exercise (PE) and mindfulness meditation (MBI), although the results on the differential effects of the two are not conclusive (Karabinski et al, 2021; Steed et al., 2021; Wendsche et al., 2021).

Thus, the present study aims to compare the differential effects of MBI and PE on different stress and health variables (self-report means and IgA and cortisol levels). A randomized controlled trial of three groups is proposed, with pretest, midtest, posttest and three follow-ups at 1, 3 and 6 months that would be developed among the Guardia Civil (Spanish military police) office staff (N ≥ 150). An MBI, an aerobic PE program and an inactive control / waiting list (LE) condition will be contrasted.

The dependent variables considered are: 1) recovery experiences; 2) perceived stress; 3) general health; 4) job satisfaction; 5) work performance; 6) positive and negative affect; 7) daily states of fatigue, stress, psychological distancing, mindfulness, and sleep; 8) IgA levels in saliva; 9) cortisol levels in saliva.

The intervention program is structured for two months, during which the two intervention groups will carry out their recovery strategy (MBI or PE), starting and increasing the practice 5 minutes every two weeks. The control group will continue as usual.

The investigators believe that this study is a quasi-pioneering initiative because of its theme, uses a robust methodology, and will have an important scientific-technical impact. The importance of the topic addressed in terms of health and business productivity is associated with important contributions in terms of knowledge transfer to companies and society in general.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* To be a full-time worker (≥35 hours/week).

Exclusion Criteria:

* Currently practicing any type of meditation regularly.
* Currently practicing physical activity (aerobic or anaerobic) more than once a week.
* To have a physical or mental illness that prevents moderate exercise or mindfulness practice.
* Very low self-perceived work load, responsability, stress levels.
* To take medication that interferes with salivary inmunoglobulin A (SIgA), i.e., pharmacological treatment that can influence the psychological state.

Primary outcomes:
measure: Change in Salivary Immunoglobulin A (SIgA)
timeFrame: Baseline 1 week before treatment, Pre-treatment the week the interventions begin, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up
measure: Change in Salivary cortisol with five points data
timeFrame: Baseline 1 week before treatment, Pre-treatment the week the interventions begin, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up
measure: Change in General Health with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
measure: Change in stress with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
measure: Change in Affective Job Satisfaction with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
measure: Change in Need for Recovery with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
measure: Change in Individual Work Performance with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
measure: Change in Positive and Negative Affect with six time points data.
timeFrame: Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up
Secondary outcomes:
measure: Change in Fatigue (single-item measure from the Single-Item Fatigue Measure)
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
timeFrame: 4 days per week during the 8-week interventions
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Raquel Ruiz Iñiguez
Study officials:
affiliation: UNED
name: Miguel A Santed, PhD
role: PRINCIPAL_INVESTIGATOR
References: