Skip to main content
OpenTrials
Completed

NCT Number: NCT05771649

Recovery Strategies Based on Mindfulness and Physical Exercise on Levels of Stress and Inmunoglobulin A

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Health Wellness Behavior Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raquel Ruiz Iñiguez

Madrid, 28009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness-based Intervention

Behavioral

A mindfulness instructor will guide focused attention meditations that will last from 15 to 30 minutes. Participants will be instructed at the beginning of the intervention and will have audio files to guide the exercises during their practice.

Physical exercise

Behavioral

An instructor will guide to running with mental association strategies that will last from 15 to 30 minutes. Participants will be instructed at the beginning of the intervention and will have audio files to guide the exercises during their practice.

Primary outcomes

  1. Change in Salivary Immunoglobulin A (SIgA) with four time points data.

    Time frame: 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

    Biological measures. Salivary IgA levels as a biomarker of mucosal immunity.

  2. Change in General Health with four time points data.

    Time frame: 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

    The General Health Questionnaire (GHQ-12) consists of 12 items. It is a unidimensional measure of psychological distress. It is answered on a Likert-type scale from 1 to 4 (1 = Never and 4 = Always). The score was used to generate a total score ranging from 0 to 36. Total scores range from 0 to 36 with a score of 11 or 12 considered typical, scores > 15 suggesting evidence of distress, and scores > 20 are considered severe problems with psychological distress.

  3. Change in stress with four time points data.

    Time frame: 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

    A single item was used: Stress refers to a person's situation when they feel tense, restless, nervous, or anxious, or are unable to sleep at night because their mind is constantly preoccupied with work-related issues. Please indicate the extent to which you currently feel this type of stress. It has five possible responses on a Likert-type scale from 1 to 5 (being 1 nothing and 5 a lot), with higher scores indicating higher perceived stress

  4. Change in Need for Recovery with four time points data.

    Time frame: 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

    The Need for Recovery (NFR) Scale consists of 9 items. It facilitates the understanding of the factors that can lead to sustainable working and employability. It is answered on a Likert-type scale from 1 to 5 (1 = Never and 5 = Always).

    The score was used to generate a total score ranging from 1 to 100.Our research team will carry the validation of the Spanish version of NFR. The higher the score, the higher the fatigue symptoms presented by the worker.

  5. Change in Academic Performance with four time points data.

    Time frame: Pre-treatment (grades before the interventions start), 1 and 3-month follow-up (grades after the interventions finish)

    Academic performance will be measured directly through the grades obtained in the academy (by course and by subject).

  6. Change in Positive and Negative Affect with four time points data.

    Time frame: 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

    The PANAS Scales of Positive and Negative Affect (PANAS) - Spanish version has 20 items. It is the most widely used scale of affectivity. It has two dominant dimensions, positive affect (10 items) and negative affect (10 items) It is answered on a Likert-type scale from 1 to 5 (1 = Very slightly or Not at all and 5 = Extremely). The score was used to generate a total score ranging from 20 to 100. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.

Secondary outcomes

  1. Change in Fatigue (single-item measure from the Single-Item Fatigue Measure)

    Time frame: Time Frame: 4 days per week during the 4-week interventions

    Single-Item on fatigue level:" Indicate what level of fatigue you felt today". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".

  2. Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).

    Time frame: Time Frame: 4 days per week during the 4-week interventions

    Single-Item on Psychological distancing level: "After work, I have been able to disconnect". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".

  3. Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).

    Time frame: Time Frame: 4 days per week during the 4-week interventions

    Single-Item on Sleep: "How did you sleep last night?". The responses are articulated on a 5-point Likert scale varying from "very bad" to "very good".

  4. Change in Stress (single-item measure from the Single-item Measure of Stress Symptoms).

    Time frame: Time Frame: 4 days per week during the 4-week interventions

    Single-Item on work stress: "Indicate the extent to which you have felt stressed, tense, nervous, or anxious today". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".

  5. Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).

    Time frame: Time Frame: 4 days per week during the 4-week interventions

    Single-Item on attention: "Today it has been difficult for me to be attentive to what required my attention at all times". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Educación a Distancia

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain
  • Universidad Rey Juan Carlos

Registry information

Official study 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

Acronym: ERME-IgA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.