Clinical trial NCT05771649: Recovery Strategies Based on Mindfulness and Physical Exercise on Levels of Stress and Inmunoglobulin A
Official title: Differential Effectiveness of Two Recovery Strategies, Based on Mindfulness and Physical Exercise, on Levels of Stress, Academic Performance, and Inmunoglobulin A. A Controlled Trial. A, and Cortisol. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Keywords: mindfulness
physical exercise
mental health
stress
recovery
Inmunoglobulin A
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: 2023-03-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A non-randomized controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 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, academic performance and health variables (self-report means and biological measure of IgA levels). A controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months that would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies.

Detailed description: Recovery from fatigue and daily stress involves mentally disconnecting from the journal. To achieve this disconnection (or psychological detachment), research has shown that engaging in a variety of interesting and motivating activities for individuals after the day 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, academic performance and health variables (self-report means and biological measure of IgA salivary levels). A non-randomized controlled trial (participant chooses to take of three groups proposed) with pretest, posttest and two follow-ups at 1 and 3 months. It would be developed among the Guardia Civil (Spanish military police) non-commissioned officers and officers academies (N ≥ 150). An MBI (focused attention meditations), an aerobic PE program (running with mental association strategies) 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) academic performance; 5) positive and negative affect; 7) daily states of fatigue, stress, psychological distancing, mindfulness, and sleep; 8) IgA levels in saliva. The intervention program is structured for four weeks, 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, and will have an important scientific and technical impact. The importance of the topic addressed in terms of health and academic performance is associated with important contributions in terms of knowledge transfer to the educational field and society in general.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.

Exclusion Criteria:

* Currently practicing any type of meditation regularly.
* To have a physical or mental illness that prevents mindfulness practice.
* To take medication that interferes with salivary inmunoglobulin A (SIgA).

Primary outcomes:
measure: Change in Salivary Immunoglobulin A (SIgA) with four time points data.
timeFrame: Baseline (1 week before interventions), Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up
measure: Change in General Health with four time points data.
timeFrame: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up
measure: Change in stress with four time points data.
timeFrame: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up
measure: Change in Need for Recovery with four time points data.
timeFrame: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up
measure: Change in Academic Performance with four time points data.
timeFrame: Pre-treatment (grades before the interventions start), 1 and 3-month follow-up (grades after the interventions finish)
measure: Change in Positive and Negative Affect with four time points data.
timeFrame: Pre-treatment (the day the interventions start), Post-treatment (4 weeks from the start of the interventions), 1-month follow-up, 3-month follow-up
Secondary outcomes:
measure: Change in Fatigue (single-item measure from the Single-Item Fatigue Measure)
timeFrame: Time Frame: 4 days per week during the 4-week interventions
measure: Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
timeFrame: Time Frame: 4 days per week during the 4-week interventions
measure: Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
timeFrame: Time Frame: 4 days per week during the 4-week interventions
measure: Change in Stress (single-item measure from the Single-item Measure of Stress Symptoms).
timeFrame: Time Frame: 4 days per week during the 4-week interventions
measure: Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
timeFrame: Time Frame: 4 days per week during the 4-week interventions
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Raquel Ruiz Iñiguez
Study officials:
References: