Mental Health WellnessERME2NCT05557266
Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Stress and Biological Measures
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 and health variables (self-report means and IgA and cortisol 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
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2023to Dec 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.
- To be a full-time worker (≥35 hours/week).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effectiveness of Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress, Inmunoglobuline 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 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.
Read the detailed description
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
- Mental Health Wellness
- Being tested
- Mindfulness-based intervention, Physical exercise
- Keywords
- mindfulness, physical exercise, meditation, mental health, stress, recovery, inmunoglobulin A, cortisol
- 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
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Single-Item on fatigue level:" Indicate what level of fatigue you felt today". The response is rcorded on a 5-point Likert scale varying from "not at all" to "very much".
Measured: 4 days per week during the 8-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: 4 days per week during the 8-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 Likert-type scale from 1 to 5
(1 = very bad and 5 = very good)
Measured: 4 days per week during the 8-week interventions
Change in Work 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: 4 days per week during the 8-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: 4 days per week during the 8-week interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startMar 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Poor recruitment. The number of interested people did not allow reaching the necessary sample size.
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
- Randomised
- Intervention model
- Factorial
- Model description
- A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1,3, and 6 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 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
- Principal investigator, Miguel Ángel Santed Germán, Universidad Nacional de Educación a Distancia
- Investigators
- Miguel A Santed, PhD, Principal investigator, UNED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557266
- Sponsor's protocol ID
- PID2019-110490RB-I00 (2)
- Acronym
- ERME2
- Status last verified
- Feb 2023
- First submitted
- 21 Sep 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effectiveness of Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress, Inmunoglobuline A, and Cortisol. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05557266
- Acronym / sponsor ID
- ERME2 / PID2019-110490RB-I00 (2)
- Conditions
- Mental Health Wellness
- Keywords
- mindfulness, physical exercise, meditation, mental health, stress, recovery, inmunoglobulin A, cortisol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor recruitment. The number of interested people did not allow reaching the necessary sample size.
- Enrolment
- 0 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
- Mar 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Sep 2022 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled trial of three groups is proposed, with pretest, posttest and three follow-ups at 1,3, and 6 months.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention (MBI) | Experimental | Behavioral: Mindfulness-based interventionA 8-week mindfulness-based intervention. From 15 to 30 minutes of practice per session, three times/week through audio guided meditations. |
| Physical exercise (PE) | Active comparator | Behavioral: Physical exerciseA 8-week physical exercise intervention. From 15 to 30 minutes of practice per session, three times/week through workout videos. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 18 to 65 years.
- To be a full-time worker (≥35 hours/week).
Key exclusion criteria (5 listed)
- 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.
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 interventionAn 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. | Behavioural | Mindfulness-based intervention (MBI) |
| Physical exerciseAn 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. | Behavioural | Physical exercise (PE) |
Primary outcome
Change in Salivary Immunoglobulin A (SIgA)
Time frame: 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
Biological measures. Salivary IgA levels as a biomarker of mucosal inmunity. Salivary IgA levels as a biomarker of mucosal inmunity
Change in Salivary cortisol with five points data
Time frame: 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
Biological measures. Salivary cortisol levels as a biomarker of stress
Change in General Health with six time points data.
Time frame: 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
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.
Change in stress with six time points data.
Time frame: 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
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)
Change in Affective Job Satisfaction with six time points data.
Time frame: 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
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.
Change in Need for Recovery with six time points data.
Time frame: 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
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.
Change in Individual Work Performance with six time points data.
Time frame: 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
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.
Change in Positive and Negative Affect with six time points data.
Time frame: 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
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.
5 secondary outcomes
Change in Fatigue (single-item measure from the Single-Item Fatigue Measure)
Time frame: 4 days per week during the 8-week interventions
Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
Time frame: 4 days per week during the 8-week interventions
Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
Time frame: 4 days per week during the 8-week interventions
Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
Time frame: 4 days per week during the 8-week interventions
Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
Time frame: 4 days per week during the 8-week interventions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Miguel A Santed, PhD principal investigator
UNED
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Feb 2023. 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 was withdrawn before enrolling participants, so there are no results.
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) (time frame: 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). The study lists 8 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 24 Feb 2023.