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

NCT05771649 | Completed

• 1 other identifier: PID2019-110490RB-I00 (3)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Keywords

mindfulness; physical exercise; mental health; stress; recovery; Inmunoglobulin A

Outcome Measures

Primary Outcomes (6)

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

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

  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

• Change in General Health with four time points data.

  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.

  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

• Change in stress with four time points data.

  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

  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

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

  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.

  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

• Change in Academic Performance with four time points data.

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

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

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

  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.

  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 (5)

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

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

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

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

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

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

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

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

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

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

Study Arms (3)

Mindfulness-based intervention (MBI)

EXPERIMENTAL

A 4-week mindfulness-based intervention comprised of focused attention meditations. From 15 to 30 minutes of practice per session, four times/week through audio guides.

Behavioral: Mindfulness-based intervention

Physical exercise (PE)

ACTIVE COMPARATOR

A 4-week physical exercise intervention comprised of running with mental association strategies. From 15 to 30 minutes of practice per session, three times/week through workout audio guides.

Behavioral: Physical exercise

Treatment as Usual (TAU)

NO INTERVENTION

The participants will continue their daily activity and obligations in the academy as usual.

Interventions

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.

Mindfulness-based intervention (MBI)

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.

Physical exercise (PE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• Universidad Rey Juan Carlos: collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (1)

Raquel Ruiz Iñiguez

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Motor Activity; Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of trial participants and care providers is not possible because of obvious differences between the interventions.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A non-randomized controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 16, 2023
• Study Start: March 6, 2023
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-02

Locations

ES (1)