StressMPSNCT04334642
Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team
A study testing A mindfulness based intervention in people with Stress, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
Trial summary
The approach of the Tokyo 2020 Paralympic Games brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of Paralympic Boccia Brazilian Team. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- A mindfulness based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2019to 25 Apr 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be an Athlete from the Paralympic Boccia Brazilian Team
Who cannot join
- Diagnosis of an active mental disorder, such as depression and anxiety, in the initial phase of treatment
- Diagnosis of an active mental disorder, such as depression and anxiety, with severe symptoms
- Having previous experience with mindfulness (regular practice in the last 6 months)
- Athletes without access to the internet or electronic means to access audio practices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team (MPS)
The approach of the Tokyo 2020 Paralympic Games brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of Paralympic Boccia Brazilian Team. Mindfulness means being aware and describes a natural human capacity that can be trained and previous researches indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context. Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study). The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes.
Read the detailed description
Since the participation of an athlete with a disability in the Olympic Games in 1904, a long road has been traveled until the Paralympic sport was understood as a standard of high performance, in which Brazil stands out when occupying the eighth place in the overall ranking of medals in the Rio 2016 Games, as well as consecutive leader in the Pan American Games (2007, 2011, 2015 and 2019). The approach of the Tokyo 2020 Paralympics brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of these athletes.
Mindfulness means being aware and describes a natural human capacity that can be trained. The option of the Paralympic Boccia Brazilian Team for a research on mindfulness is because of the identification of previous researches that indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context.
Considering that sports performance is composed of several pillars, such as physical, technical, tactical and psychological, there is an opportunity to investigate the following findings of mindfulness-based interventions in a complex population:
Mindfulness practice consistently and significantly improves levels of mindfulness across various sports disciplines.
Physiological and psychological performance improved significantly until the practice of mindfulness.
Based on the available evidence, the practice of mindfulness can be considered as a supplementary training approach to improve performance in precision sports disciplines.
Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention (MBI) on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is an exploratory study (pilot) to verify if the intervention will be well accepted by the participants (feasibility) and if it will be effective to reproduce the expected effects (preliminary effectiveness) composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study).
The research will have as a convenience sample 11 Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. This study includes the category called "Other participants" formed by staff, freshmen, technicians and other professionals who are present during the interventions. In this way, the participants totalize 25 people: there are eleven athletes categorized as "Athletes" and 14 professionals in the "Other Participants" category. The measure instruments used in the Athletes category will be the same in the Other participants category, with the exception of Performance Evaluation applied only to Athletes.
The methodological procedures of the present work were prepared within the fundamental ethical and scientific procedures, as provided for in Resolution No. 466 of December 12, 2012 of the National Health Council of Ministry of Health, being approved by the Research Ethics Committee (CEP), by protocol 19577519.2.0000.5505.
The intervention will take place at the Brazilian Paralympic Training Center - CTPB, in the City of São Paulo, SP, where an certified instructor with extensive experience in leading groups by Centro Mente Aberta - UNIFESP will conduct the MBI and recommend to athletes to incorporate formal and informal care practices into their daily lives.
It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes. In this sense, it produces practical scientific knowledge that can pave the way for the subsequent realization of a large-scale trial that will benefit the greatest number of people.
The investigation is limited by the lack of additional comparison groups and the small sample size to detect effects. However, this is justified by being Paralympic medalists who have a series of unique characteristics, according to the functional classification that includes people with severe or severe motor disabilities, caused basically by cerebral palsy, cervical spinal cord injuries and muscular dystrophies.
The relevance of this research is in its pioneering spirit and originality when evaluating the first intervention based on mindfulness with Paralympic athletes held in Brazil.
- Conditions
- Stress
- Being tested
- A mindfulness based intervention
- Keywords
- Paralympic Games, Mindfulness, Sport, Athletes, Boccia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mindfulness based interventionOther
Also called Mindfulness Training, MBHP
It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study).
| Study group | Role | What they receive |
|---|---|---|
| Athletes from the Paralympic Boccia Brazilian Team | Experimental | The research will have as a convenience sample 11 Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. This study includes the category called Other participants formed by staff, freshmen, technicians and other professionals who are present during the interventions. Receives: Other: A mindfulness based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
WHOQOL-bref means World Health Organization Quality of Life Assessment - bref. This Scale assesses quality of life: it is an abbreviated version of the WHOQOL-100 with 26 questions divided into four domains, namely, physical, psychological, social relations and the environment. The answers follow a Likert scale (from 1 to 5, how much the higher the score the better the quality of life).
Measured: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)
Secondary outcomes (2)
Change of sports performance
The Pitch Accuracy Test used by the Brazilian Boccia Team in a regular basis.
Measured: T0 (baseline), T4 (12 months)
Change of sports performance (II)
The Ball Speed Test used by the Brazilian Boccia Team in a regular basis.
Measured: T0 (baseline), T4 (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start30 Jun 2019
- Primary completion10 Dec 2020
- Study completion25 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Mente Aberta de Mindfulness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness
- Investigators
- Marlúcia S Jesus, Student, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334642
- Sponsor's protocol ID
- 19577519.2.0000.5505
- Acronym
- MPS
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared by research gate.
Publications
Rothlin P, Birrer D, Horvath S, Grosse Holtforth M. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment. BMC Psychol. 2016 Jul 26;4(1):39. doi: 10.1186/s40359-016-0147-y.
PubMed 27457721Buhlmayer L, Birrer D, Rothlin P, Faude O, Donath L. Effects of Mindfulness Practice on Performance-Relevant Parameters and Performance Outcomes in Sports: A Meta-Analytical Review. Sports Med. 2017 Nov;47(11):2309-2321. doi: 10.1007/s40279-017-0752-9.
PubMed 28664327Kozasa EH, Sato JR, Lacerda SS, Barreiros MA, Radvany J, Russell TA, Sanches LG, Mello LE, Amaro E Jr. Meditation training increases brain efficiency in an attention task. Neuroimage. 2012 Jan 2;59(1):745-9. doi: 10.1016/j.neuroimage.2011.06.088. Epub 2011 Jul 7.
PubMed 21763432Jones G. More than just a game: research developments and issues in competitive anxiety in sport. Br J Psychol. 1995 Nov;86 ( Pt 4):449-78. doi: 10.1111/j.2044-8295.1995.tb02565.x.
PubMed 8542197Hardy L, Jones G. Current issues and future directions for performance-related research in sport psychology. J Sports Sci. 1994 Feb;12(1):61-92. doi: 10.1080/02640419408732158.
PubMed 8158748Burns L, Weissensteiner JR, Cohen M. Lifestyles and mindsets of Olympic, Paralympic and world champions: is an integrated approach the key to elite performance? Br J Sports Med. 2019 Jul;53(13):818-824. doi: 10.1136/bjsports-2018-099217. Epub 2018 Oct 23.
PubMed 30352862Navarro-Haro MV, Lopez-Del-Hoyo Y, Campos D, Linehan MM, Hoffman HG, Garcia-Palacios A, Modrego-Alarcon M, Borao L, Garcia-Campayo J. Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. PLoS One. 2017 Nov 22;12(11):e0187777. doi: 10.1371/journal.pone.0187777. eCollection 2017.
PubMed 29166665Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10.
PubMed 18329323
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team (MPS)
- ClinicalTrials.gov ID
- NCT04334642
- Acronym / sponsor ID
- MPS / 19577519.2.0000.5505
- Conditions
- Stress
- Keywords
- Paralympic Games, Mindfulness, Sport, Athletes, Boccia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centro Mente Aberta de MindfulnessUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 25 Apr 2021 (estimated)
- First posted
- 6 Apr 2020 (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 approach of the Tokyo 2020 Paralympic Games brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of Paralympic Boccia Brazilian Team. Mindfulness means being aware and describes a natural human capacity that can be trained and previous researches indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context. Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study). The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes.
Detailed description
Since the participation of an athlete with a disability in the Olympic Games in 1904, a long road has been traveled until the Paralympic sport was understood as a standard of high performance, in which Brazil stands out when occupying the eighth place in the overall ranking of medals in the Rio 2016 Games, as well as consecutive leader in the Pan American Games (2007, 2011, 2015 and 2019). The approach of the Tokyo 2020 Paralympics brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of these athletes.
Mindfulness means being aware and describes a natural human capacity that can be trained. The option of the Paralympic Boccia Brazilian Team for a research on mindfulness is because of the identification of previous researches that indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context.
Considering that sports performance is composed of several pillars, such as physical, technical, tactical and psychological, there is an opportunity to investigate the following findings of mindfulness-based interventions in a complex population:
Mindfulness practice consistently and significantly improves levels of mindfulness across various sports disciplines.
Physiological and psychological performance improved significantly until the practice of mindfulness.
Based on the available evidence, the practice of mindfulness can be considered as a supplementary training approach to improve performance in precision sports disciplines.
Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention (MBI) on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is an exploratory study (pilot) to verify if the intervention will be well accepted by the participants (feasibility) and if it will be effective to reproduce the expected effects (preliminary effectiveness) composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study).
The research will have as a convenience sample 11 Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. This study includes the category called "Other participants" formed by staff, freshmen, technicians and other professionals who are present during the interventions. In this way, the participants totalize 25 people: there are eleven athletes categorized as "Athletes" and 14 professionals in the "Other Participants" category. The measure instruments used in the Athletes category will be the same in the Other participants category, with the exception of Performance Evaluation applied only to Athletes.
The methodological procedures of the present work were prepared within the fundamental ethical and scientific procedures, as provided for in Resolution No. 466 of December 12, 2012 of the National Health Council of Ministry of Health, being approved by the Research Ethics Committee (CEP), by protocol 19577519.2.0000.5505.
The intervention will take place at the Brazilian Paralympic Training Center - CTPB, in the City of São Paulo, SP, where an certified instructor with extensive experience in leading groups by Centro Mente Aberta - UNIFESP will conduct the MBI and recommend to athletes to incorporate formal and informal care practices into their daily lives.
It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes. In this sense, it produces practical scientific knowledge that can pave the way for the subsequent realization of a large-scale trial that will benefit the greatest number of people.
The investigation is limited by the lack of additional comparison groups and the small sample size to detect effects. However, this is justified by being Paralympic medalists who have a series of unique characteristics, according to the functional classification that includes people with severe or severe motor disabilities, caused basically by cerebral palsy, cervical spinal cord injuries and muscular dystrophies.
The relevance of this research is in its pioneering spirit and originality when evaluating the first intervention based on mindfulness with Paralympic athletes held in Brazil.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis.
| Arm | Type | Receives |
|---|---|---|
| Athletes from the Paralympic Boccia Brazilian Team | Experimental | Other: A mindfulness based interventionThe research will have as a convenience sample 11 Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. This study includes the category called Other participants formed by staff, freshmen, technicians and other professionals who are present during the interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be an Athlete from the Paralympic Boccia Brazilian Team
Key exclusion criteria (4 listed)
- Diagnosis of an active mental disorder, such as depression and anxiety, in the initial phase of treatment
- Diagnosis of an active mental disorder, such as depression and anxiety, with severe symptoms
- Having previous experience with mindfulness (regular practice in the last 6 months)
- Athletes without access to the internet or electronic means to access audio practices
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 |
|---|---|---|
| A mindfulness based interventionAlso: Mindfulness Training, MBHPIt is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study). | Other | Athletes from the Paralympic Boccia Brazilian Team |
Primary outcome
Change in quality of life
Time frame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)
WHOQOL-bref means World Health Organization Quality of Life Assessment - bref. This Scale assesses quality of life: it is an abbreviated version of the WHOQOL-100 with 26 questions divided into four domains, namely, physical, psychological, social relations and the environment. The answers follow a Likert scale (from 1 to 5, how much the higher the score the better the quality of life).
2 secondary outcomes
Change of sports performance
Time frame: T0 (baseline), T4 (12 months)
Change of sports performance (II)
Time frame: T0 (baseline), T4 (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 27457721Rothlin P, Birrer D, Horvath S, Grosse Holtforth M. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment. BMC Psychol. 2016 Jul 26;4(1):39. doi: 10.1186/s40359-016-0147-y.
- Background: PubMed 28664327Buhlmayer L, Birrer D, Rothlin P, Faude O, Donath L. Effects of Mindfulness Practice on Performance-Relevant Parameters and Performance Outcomes in Sports: A Meta-Analytical Review. Sports Med. 2017 Nov;47(11):2309-2321. doi: 10.1007/s40279-017-0752-9.
- Background: PubMed 21763432Kozasa EH, Sato JR, Lacerda SS, Barreiros MA, Radvany J, Russell TA, Sanches LG, Mello LE, Amaro E Jr. Meditation training increases brain efficiency in an attention task. Neuroimage. 2012 Jan 2;59(1):745-9. doi: 10.1016/j.neuroimage.2011.06.088. Epub 2011 Jul 7.
- Background: PubMed 8542197Jones G. More than just a game: research developments and issues in competitive anxiety in sport. Br J Psychol. 1995 Nov;86 ( Pt 4):449-78. doi: 10.1111/j.2044-8295.1995.tb02565.x.
- Background: PubMed 8158748Hardy L, Jones G. Current issues and future directions for performance-related research in sport psychology. J Sports Sci. 1994 Feb;12(1):61-92. doi: 10.1080/02640419408732158.
- Background: PubMed 30352862Burns L, Weissensteiner JR, Cohen M. Lifestyles and mindsets of Olympic, Paralympic and world champions: is an integrated approach the key to elite performance? Br J Sports Med. 2019 Jul;53(13):818-824. doi: 10.1136/bjsports-2018-099217. Epub 2018 Oct 23.
- Background: PubMed 29166665Navarro-Haro MV, Lopez-Del-Hoyo Y, Campos D, Linehan MM, Hoffman HG, Garcia-Palacios A, Modrego-Alarcon M, Borao L, Garcia-Campayo J. Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. PLoS One. 2017 Nov 22;12(11):e0187777. doi: 10.1371/journal.pone.0187777. eCollection 2017.
- Background: PubMed 18329323Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10.
- Conde, AJM. Memória Paralímpica. vol. I São Paulo: Comitê Paralímpico Brasileiro; 2018. Accessed June 15, 2019.Link provided by the sponsor.
- Winckler C, Oliveira MC. O esporte Paralímpico e os caminhos para a inclusão social. Revista Científica Virtual da ESA, v. 27, p. 176-186, 2018. Accessed June 15, 2019Link provided by the sponsor.
- BISFed International Boccia Rules - 2018 (v.3). Accessed May 15, 2019.Link provided by the sponsor.
- O que é Bocha. Accessed May 10, 2019.Link provided by the sponsor.
- Kabat-Zinn J. Mindfulness-Based Interventions in Context: Past, Present, and Future. Clin Psychi-Sci Pract. 2003;10:144-56. Doi: 10.1093/clipsy.bpg0.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared by research gate.
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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.
Marlúcia S Jesus, Student principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mindfulness based intervention in people with Stress, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Brazil. 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?
Results are not available in the source record.
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 quality of life (time frame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334642, which also lists 8 linked publications.
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 10 Feb 2021.