Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Stress and Biological Measures

NCT ID: NCT05557266

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-12-31

Brief Summary

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The present study aims to compare the differential effects of mindfulness meditation (MBI) and physical exercise (PE) on different stress and health variables (self-report means and IgA and cortisol levels). A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1, 3 and 6 months that would be developed among the Guardia Civil (Spanish military police) office staff.

Detailed Description

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Recovery from fatigue and daily work stress involves mentally disconnecting from work. To achieve this disconnection (or psychological detachment), research has shown that engaging in a variety of interesting and motivating activities for individuals after the workday 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 and health variables (self-report means and IgA and cortisol levels). A randomized controlled trial of three groups is proposed, with pretest, midtest, posttest and three follow-ups at 1, 3 and 6 months that would be developed among the Guardia Civil (Spanish military police) office staff (N ≥ 150). An MBI, an aerobic PE program 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) job satisfaction; 5) work performance; 6) positive and negative affect; 7) daily states of fatigue, stress, psychological distancing, mindfulness, and sleep; 8) IgA levels in saliva; 9) cortisol levels in saliva.

The intervention program is structured for two months, 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, uses a robust methodology, and will have an important scientific-technical impact. The importance of the topic addressed in terms of health and business productivity is associated with important contributions in terms of knowledge transfer to companies and society in general.

Conditions

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Mental Health Wellness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1,3, and 6 months.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Blinding of trial participants and care providers is not possible because of obvious differences between the interventions.

Study Groups

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Mindfulness-based intervention (MBI)

A 8-week mindfulness-based intervention. From 15 to 30 minutes of practice per session, three times/week through audio guided meditations.

Group Type EXPERIMENTAL

Mindfulness-based intervention

Intervention Type BEHAVIORAL

An mindfulness instructor will conduct meditations lasting 15 to 30 minutes. The first day of each week the intervention will be given in streaming and the rest of the days the participants will have audio files designed ad hoc with the practice of the week so they can do it individually at home.

Physical exercise (PE)

A 8-week physical exercise intervention. From 15 to 30 minutes of practice per session, three times/week through workout videos.

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type BEHAVIORAL

An aerobic and fitness trainer will conduct aerobic exercise lasting 15 to 30 minutes. The first day of each week the intervention will be given in streaming and the rest of the days the participants will have video files designed ad hoc with the practice of the week so they can do it individually at home.The intensity of the chosen exercise will be moderate, maintaining between 120-140 beats per minute.

Wait list (WL)

The participants will continue their work activity as usual. This arm will be invited to a mindfulness training once the study finished.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based intervention

An mindfulness instructor will conduct meditations lasting 15 to 30 minutes. The first day of each week the intervention will be given in streaming and the rest of the days the participants will have audio files designed ad hoc with the practice of the week so they can do it individually at home.

Intervention Type BEHAVIORAL

Physical exercise

An aerobic and fitness trainer will conduct aerobic exercise lasting 15 to 30 minutes. The first day of each week the intervention will be given in streaming and the rest of the days the participants will have video files designed ad hoc with the practice of the week so they can do it individually at home.The intensity of the chosen exercise will be moderate, maintaining between 120-140 beats per minute.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age from 18 to 65 years.
* To be a full-time worker (≥35 hours/week).

Exclusion Criteria

* Currently practicing any type of meditation regularly.
* Currently practicing physical activity (aerobic or anaerobic) more than once a week.
* To have a physical or mental illness that prevents moderate exercise or mindfulness practice.
* Very low self-perceived work load, responsability, stress levels.
* To take medication that interferes with salivary inmunoglobulin A (SIgA), i.e., pharmacological treatment that can influence the psychological state.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role lead

Responsible Party

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Miguel Ángel Santed Germán

PhD, Clinical Psychologist and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel A Santed, PhD

Role: PRINCIPAL_INVESTIGATOR

UNED

Locations

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Raquel Ruiz Iñiguez

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PID2019-110490RB-I00 (2)

Identifier Type: -

Identifier Source: org_study_id

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