Mental Health WellnessERME-IgANCT05771649
Recovery Strategies Based on Mindfulness and Physical Exercise on Levels of Stress and Inmunoglobulin A
A study testing Mindfulness-based intervention and Physical exercise in people with Mental Health Wellness, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- Mindfulness-based intervention and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Mental Health Wellness
- Being tested
- Mindfulness-based intervention, Physical exercise
- Keywords
- mindfulness, physical exercise, mental health, stress, recovery, Inmunoglobulin A
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical exercise |
| Treatment as Usual (TAU) | No intervention | The participants will continue their daily activity and obligations in the academy as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Immunoglobulin A (SIgA) with four time points data.
Biological measures. Salivary IgA levels as a biomarker of mucosal immunity.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
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".
Measured: Time Frame: 4 days per week during the 4-week interventions
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".
Measured: Time Frame: 4 days per week during the 4-week interventions
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".
Measured: 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).
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".
Measured: Time Frame: 4 days per week during the 4-week interventions
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".
Measured: Time Frame: 4 days per week during the 4-week interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start6 Mar 2023
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- A non-randomized controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771649
- Sponsor's protocol ID
- PID2019-110490RB-I00 (3)
- Acronym
- ERME-IgA
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05771649
- Acronym / sponsor ID
- ERME-IgA / PID2019-110490RB-I00 (3)
- Conditions
- Mental Health Wellness
- Keywords
- mindfulness, physical exercise, mental health, stress, recovery, Inmunoglobulin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Ministerio de Ciencia e Innovación, Spain
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A non-randomized controlled trial of three groups is proposed, with pretest, posttest and two follow-ups at 1 and 3 months.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention (MBI) | Experimental | Behavioral: Mindfulness-based interventionA 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. |
| Physical exercise (PE) | Active comparator | Behavioral: Physical exerciseA 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. |
| Treatment as Usual (TAU) | No intervention | –The participants will continue their daily activity and obligations in the academy as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age from 18 to 65 years.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionA 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. | Behavioural | Mindfulness-based intervention (MBI) |
| Physical exerciseAn 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. | Behavioural | Physical exercise (PE) |
Primary outcome
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.
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.
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
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.
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).
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided. The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention and Physical exercise in people with Mental Health Wellness, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.