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CompletedNCT05771649ERME-IgAUpdated Jan 9, 2024

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

An interventional study of Mindfulness-based intervention and Physical exercise in Mental Health Wellness, sponsored by Universidad Nacional de Educación a Distancia. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Universidad Nacional de Educación a Distancia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mental Health Wellness

Keywords

  • mindfulness
  • physical exercise
  • mental health
  • stress
  • recovery
  • Inmunoglobulin A
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 150 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Universidad Nacional de Educación a Distancia is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age from 18 to 65 years.

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Mindfulness-based intervention (MBI)

    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

  • Active comparator
    Physical exercise (PE)

    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

  • No intervention
    Treatment as Usual (TAU)

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

Interventions

  • BehavioralMindfulness-based intervention

    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.

  • BehavioralPhysical exercise

    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.

06

What researchers measure

Primary outcomes

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

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

    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

  2. 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.

    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

  3. 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

    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

  4. 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.

    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

  5. 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).

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

  6. 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.

    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

Secondary outcomes

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

    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".

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

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

    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".

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

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

    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".

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

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

    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".

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

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

    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".

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

07

Study locations

1 site
  • Raquel Ruiz Iñiguez
    Madrid, 28009, Spain
08

References and documents

Individual participant data

Plan to share: Undecided — The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05771649
Lead sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad Rey Juan Carlos, Ministerio de Ciencia e Innovación, Spain
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Mar 6, 2023
Primary completion
Mar 30, 2023
Completion
Jun 30, 2023
Last update
Jan 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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