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

NCT05557266 | Withdrawn

• 1 other identifier: PID2019-110490RB-I00 (2)
• Study Type: interventional
• Target: N/A
• 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 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.

Conditions

Mental Health Wellness

Keywords

mindfulness; physical exercise; meditation; mental health; stress; recovery; inmunoglobulin A; cortisol

Outcome Measures

Primary Outcomes (8)

• Change in Salivary Immunoglobulin A (SIgA)

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

  Baseline 1 week before treatment, Pre-treatment the week the interventions begin, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up

• Change in Salivary cortisol with five points data

  Biological measures. Salivary cortisol levels as a biomarker of stress

  Baseline 1 week before treatment, Pre-treatment the week the interventions begin, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up

• Change in General Health with six 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.

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

• Change in stress with six 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)

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

• Change in Affective Job Satisfaction with six time points data.

  The Brief Index of Affective Job Satisfaction (BIAJS)-Spanish version (BIAJS) consists of 7 items. It is an overall measure of affective job satisfaction. It measures satisfaction in five facets: promotion, co-workers, work itself, supervision and salary. It is answered on a Likert-type scale from 1 to 5 (1 = Strongly disagree and 5 = Strongly agree). The score was used to generate a total score ranging from 7 to 35.

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

• Change in Need for Recovery with six 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.

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

• Change in Individual Work Performance with six time points data.

  The Individual Work Performance Questionnaire (IWPQ)-Brief Spanish version (IWPQ) has 18 items. It measures the three main dimensions of job performance: task performance, contextual performance, and counterproductive work behavior. It is answered on a Likert-type scale from 1 to 5 (1 = Never or Seldom and 5 = Always or Often). The score was used to generate a total score ranging from 18 to 90.

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

• Change in Positive and Negative Affect with six 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.

  Baseline 1 week before treatment, Mid-treatment 5 weeks from baseline, Post-treatment 9 weeks from baseline, 1-month follow-up, 3-months follow-up, and 6-months follow-up

Secondary Outcomes (5)

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

  4 days per week during the 8-week interventions

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

  4 days per week during the 8-week interventions

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

  4 days per week during the 8-week interventions

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

  4 days per week during the 8-week interventions

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

  4 days per week during the 8-week interventions

Study Arms (3)

Mindfulness-based intervention (MBI)

EXPERIMENTAL

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

Behavioral: Mindfulness-based intervention

Physical exercise (PE)

ACTIVE COMPARATOR

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

Behavioral: Physical exercise

Wait list (WL)

NO INTERVENTION

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

Interventions

Mindfulness-based intervention 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.

Mindfulness-based intervention (MBI)

Physical exercise 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.

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.
• To be a full-time worker (≥35 hours/week).

You may not qualify if:

• 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.

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 Officials

• Miguel A Santed, PhD

  UNED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Clinical Psychologist and Professor

Model Details: A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1,3, and 6 months.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 27, 2022
• Study Start: March 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

ES (1)