Well-beingMindfulstudNCT03669016
MIndfulness for Students
A study testing Face-to-face group-based mindfulness and Internet-based mindfulness in people with Well-being and Functional Ability, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of the study is to find out, weather the students' wellbeing and functional ability can be enhanced by two different type of mindfulness interventions: 1) face-to-face group-based training, and 2) internet-based training based in mindfulness and acceptance and commitment therapy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Well-being, Functional Ability, Stress
- What is being tested?
- Face-to-face group-based mindfulness and Internet-based mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 22 Aug 2018to 15 Apr 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All undergraduate students of Faculty of Medicine, University of Helsinki who have started their studies in year 2009 or after that.
Who cannot join
- The participants that can not participate fully to the intervention (self-evaluated).
- Participants who have severe mental problems (like anxiety or depression) when the study starts,
- Participants who have hade a great loss or trauma in near past, or some other mental or physical health problem that could make participation difficult.
- This is evaluated based on how the participants answers to the base line questionnaire the following measures:
- answers to the CORE-OM questionnaire and
- answers to the questions where participants evaluate themselves their anxiety, depression, mental health.
- If participant tell they have some other mental disorder, they are not accepted to the study.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Helsinki
Helsinki, University of Helsinki, 00014
Saara Repo, PhD, +358405189456, saara.repo@helsinki.fi
Tiina Paunio, PhD, +358947163734, tiina.paunio@helsinki.fi
About this study
Official title: Mindfulness for Students
The aim of the study is to find out, weather the students' wellbeing and functional ability can be enhanced by two different type of mindfulness interventions: 1) face-to-face group-based training, and 2) internet-based training based in mindfulness and acceptance and commitment therapy. Study results may be used to decide whether it is worth offering mindfulness training for medical faculty students, and what kind of training would be most suitable and effective in the medical education context.
Read the detailed description
The hypotheses is that participating to the mindfulness intervention improves students well-being and decreases their level of stress. These are measured by self-evaluation questionnaires and with hair samples, before the intervention, immediately after intervention and four months after the intervention.
This is a randomized control trial. There are two different experiment groups and one waiting-list control group. The target group is all undergraduate students in the Faculty of Medicine, University of Helsinki. The participants are recruited with e-mail and informing students in different situations. The aimed amount of participants is 120-150 but the study will be conducted if 90 participants are recruited. The participants enroll to the study by signing consent format.
This is a follow-up research. The person register (name, university e-mail address, student number) are used to recruitment and to ensure the participants identity.
Time of data preservation is 10 years. The last student register data is going to be collected 2019. The data is preserved until age 2029.
The questionnaire with which the main data is been collected is Webropol questionnaire tool. The data is removed from the Webropol after three months of the end of the questionnaire answer time. The person responsible for the data removes the data from University's server after ten years.
Content of the register
- Mindfulness for Students questionnaire data
- Mindfulness for Students hair samples
- Mindfulness for students -observation log
- Mindfulness for students -interview data
- Data collected in Student Compass -internet environment
- Data of students' credits are collected from University's own credit register "Oodi", if participant has given a consent to that.
Students are being recruited in information meeting. They will be informed orally in that situation and given a written communication paper. The students who want to participate the course, will fill and sign a consent format. In format there is a research number code given to the student. The connection between the student identity and the research code number is known only by the persons that are responsible for the database.
- Conditions
- Well-being, Functional Ability, Stress, Mindfulness
- Being tested
- Face-to-face group-based mindfulness, Internet-based mindfulness
- Keywords
- well-being, functional ability, stress, mindfulness, undergaduate students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face group-based mindfulnessBehavioural
An eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. An eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. This training is based on Jon Kabat-Zinn's course Mindfulness Based Stress Reduction and book Williams \& Penman Mindfulness: a practical guide to finding peace in a frantic world and adapted for university students. In addition, a manual written in Cambridge University "Mindfulness Skills for Students" is utilized.
Internet-based mindfulnessBehavioural
An eight-week course, including 60 minutes starting and ending meeting. Participants are practicing mindfulness, doing other tasks (writing, reading, reflecting) on their own. This course is created in University of Jyväskylä, Finland. It is based on mindfulness and Acceptance and Commmitment Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face group-based mindfulness | Experimental | 8 weeks training. Receives: Behavioral: Face-to-face group-based mindfulness |
| Internet-based mindfulness | Experimental | 8 weeks training. Receives: Behavioral: Internet-based mindfulness |
| Waiting-list control group | No intervention | No training during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Secondary outcomes (25)
Change from Baseline rate of stress at post-intervention and 4-month follow-up.
Cortisol as an indicator of stress which is measured from hair samples. Stadler \& Kirschbaum 2012.
Measured: It is measured in the same day when the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of resilience in studies at post-intervention and 4-month follow-up.
Workplace Acceptance and Action Questionnaire (WAAQ) applied for students. Bond, Joda, and Guenole 2013; Asikainen, Hailikari, Mattson 2017.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of social support in studies at post-intervention and 4-month follow-up.
Application of questionnaires of social support from Sarason et al. 1987 and Pyörälä et al. 2015.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of study load in studies at post-intervention and 4-month follow-up.
Application of questionnaire of healthy work measure of Karasek \& Theorell 1990.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Students' possibilities to influence to their own studies
Application of measures of healthy work measure. Karasek \& Theorell 1990.
Measured: It is measured three weeks before the interventions start.
Change from Baseline rate of functional ability in studies at post-intervention and 4-month follow-up.
Application of functional ability at work. Tuomi et al. 1998.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of subjective experience of quality of life at post-intervention and 4-month follow-up.
Subjective experience of quality of life. One Likert-scale question adapted and modified from three different questionnaires. Koivumaa et al. 2000; Allardt 1973; Lundqvist \& Mäkiopas 2016)
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of mental well-being Scale at post-intervention and 4-month follow-up.
The Warwick-Edinburgh Mental Well-being Scale
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Personality at post-intervention and 4-month follow-up.
Parts of Big Five (Lang et al. 2011)
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of sense of coherence at post-intervention and 4-month follow-up.
Sence of coherence - SOC 3 (Antonovsky 1987; Schumann et al. 2003)
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Resilience at post-intervention and 4-month follow-up.
Resilience scale (Wagnild \& Young, 1993; Losoi et al 2013 modified)
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of experiences of own health at post-intervention and 4-month follow-up.
Questionnaire Kunttu et al. 2017
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of quality and length of sleep at post-intervention and 4-month follow-up.
Basic Nordic Sleep Questionnaire shortened (Partinen \& Gislason 1995)
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of fatigue in day-time at post-intervention and 4-month follow-up.
Questionnaire from Health 2000/2001 Research in Finland
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline amount of nightmares during previous month at post-intervention and 4-month follow-up.
Application of questionnaire Sandman et al 2015.
Measured: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Participant's own evaluation of his/her mental health
Participant's own evaluation of the symptoms of mental health during previous month.
Measured: Three weeks before the intervention starts
Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.
Questionnaire from Health 2000/2001 Research in Finland
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline regularity of eating habits at post-intervention and 4-month follow-up.
Participant's own evaluation of the regularity of eating habits.
Measured: It is measured before intervention, post-intervention and 4-month follow-up.
Change from Baseline approximate amount of caffeine used daily. at post-intervention and 4-month follow-up.
Participant's own evaluation of the amount of daily caffeine use.
Measured: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline approximate amount use of alcohol and cigarettes daily.
Participant's own evaluation of approximate amount use of alcohol and cigarettes daily.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Mindfulness skills at post-intervention and 4-month follow-up.
Freiburg Mindfulness Index (FMI) Walach, H., Buchheld, N., Buttenmüller, V., Kleinknecht, N., \& Schmidt, S. 2006; Lehto, Uusitalo-Malmivaara \& Repo 2015.
Measured: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.
Application of measures of healthy work measure of Lundqvist \& Mäkiopas 2016 and Elo et al. 1992.
Measured: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Previous experience in practicing of mindfulness and/or meditation
Participant's own evaluation of the amount of previous experience in practicing mindfulness and/or meditation
Measured: It is measured three weeks before the intervention starts.
Amount and quality of independent mindfulness practice
Participant's self-evaluation of amount and quality of independent mindfulness practice
Measured: Immediately after the 8-week intervention is finished.
Change from post-intervention amount and quality of independent mindfulness practice at 4-month follow-up.
Participant's self-evaluation of amount and quality of independent mindfulness practice.
Measured: Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start22 Aug 2018
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Jyvaskyla, Technische Universität Dresden
- Responsible party
- Principal investigator, Saara Repo, University of Helsinki
- Investigators
- Saara Repo, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669016
- Sponsor's protocol ID
- MIndfulness for Students
- Acronym
- Mindfulstud
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller R, Wankerl M, Stalder T, Kirschbaum C, Alexander N. The serotonin transporter gene-linked polymorphic region (5-HTTLPR) and cortisol stress reactivity: a meta-analysis. Mol Psychiatry. 2013 Sep;18(9):1018-24. doi: 10.1038/mp.2012.124. Epub 2012 Sep 4.
PubMed 22945032Daya Z, Hearn JH. Mindfulness interventions in medical education: A systematic review of their impact on medical student stress, depression, fatigue and burnout. Med Teach. 2018 Feb;40(2):146-153. doi: 10.1080/0142159X.2017.1394999. Epub 2017 Nov 7.
PubMed 29113526Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.
PubMed 29422189Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
PubMed 32691879
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Students
- ClinicalTrials.gov ID
- NCT03669016
- Acronym / sponsor ID
- Mindfulstud / MIndfulness for Students
- Conditions
- Well-being, Functional Ability, Stress, Mindfulness
- Keywords
- well-being, functional ability, stress, mindfulness, undergaduate students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Jyvaskyla, Technische Universität Dresden
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 13 Sep 2018 (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 aim of the study is to find out, weather the students' wellbeing and functional ability can be enhanced by two different type of mindfulness interventions: 1) face-to-face group-based training, and 2) internet-based training based in mindfulness and acceptance and commitment therapy. Study results may be used to decide whether it is worth offering mindfulness training for medical faculty students, and what kind of training would be most suitable and effective in the medical education context.
Detailed description
The hypotheses is that participating to the mindfulness intervention improves students well-being and decreases their level of stress. These are measured by self-evaluation questionnaires and with hair samples, before the intervention, immediately after intervention and four months after the intervention.
This is a randomized control trial. There are two different experiment groups and one waiting-list control group. The target group is all undergraduate students in the Faculty of Medicine, University of Helsinki. The participants are recruited with e-mail and informing students in different situations. The aimed amount of participants is 120-150 but the study will be conducted if 90 participants are recruited. The participants enroll to the study by signing consent format.
This is a follow-up research. The person register (name, university e-mail address, student number) are used to recruitment and to ensure the participants identity.
Time of data preservation is 10 years. The last student register data is going to be collected 2019. The data is preserved until age 2029.
The questionnaire with which the main data is been collected is Webropol questionnaire tool. The data is removed from the Webropol after three months of the end of the questionnaire answer time. The person responsible for the data removes the data from University's server after ten years.
Content of the register
- Mindfulness for Students questionnaire data
- Mindfulness for Students hair samples
- Mindfulness for students -observation log
- Mindfulness for students -interview data
- Data collected in Student Compass -internet environment
- Data of students' credits are collected from University's own credit register "Oodi", if participant has given a consent to that.
Students are being recruited in information meeting. They will be informed orally in that situation and given a written communication paper. The students who want to participate the course, will fill and sign a consent format. In format there is a research number code given to the student. The connection between the student identity and the research code number is known only by the persons that are responsible for the database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face group-based mindfulness | Experimental | Behavioral: Face-to-face group-based mindfulness8 weeks training. |
| Internet-based mindfulness | Experimental | Behavioral: Internet-based mindfulness8 weeks training. |
| Waiting-list control group | No intervention | –No training during the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All undergraduate students of Faculty of Medicine, University of Helsinki who have started their studies in year 2009 or after that.
Key exclusion criteria (7 listed)
- The participants that can not participate fully to the intervention (self-evaluated).
- Participants who have severe mental problems (like anxiety or depression) when the study starts,
- Participants who have hade a great loss or trauma in near past, or some other mental or physical health problem that could make participation difficult.
- This is evaluated based on how the participants answers to the base line questionnaire the following measures:
- answers to the CORE-OM questionnaire and
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 |
|---|---|---|
| Face-to-face group-based mindfulnessAn eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. An eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. This training is based on Jon Kabat-Zinn's course Mindfulness Based Stress Reduction and book Williams \& Penman Mindfulness: a practical guide to finding peace in a frantic world and adapted for university students. In addition, a manual written in Cambridge University "Mindfulness Skills for Students" is utilized. | Behavioural | Face-to-face group-based mindfulness |
| Internet-based mindfulnessAn eight-week course, including 60 minutes starting and ending meeting. Participants are practicing mindfulness, doing other tasks (writing, reading, reflecting) on their own. This course is created in University of Jyväskylä, Finland. It is based on mindfulness and Acceptance and Commmitment Therapy. | Behavioural | Internet-based mindfulness |
Primary outcome
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure.
25 secondary outcomes
Change from Baseline rate of stress at post-intervention and 4-month follow-up.
Time frame: It is measured in the same day when the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of resilience in studies at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of social support in studies at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of study load in studies at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Students' possibilities to influence to their own studies
Time frame: It is measured three weeks before the interventions start.
Change from Baseline rate of functional ability in studies at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of subjective experience of quality of life at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of mental well-being Scale at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Personality at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of sense of coherence at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Resilience at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of experiences of own health at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of quality and length of sleep at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of fatigue in day-time at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline amount of nightmares during previous month at post-intervention and 4-month follow-up.
Time frame: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Participant's own evaluation of his/her mental health
Time frame: Three weeks before the intervention starts
Change from Baseline approximate amount of exercise at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline regularity of eating habits at post-intervention and 4-month follow-up.
Time frame: It is measured before intervention, post-intervention and 4-month follow-up.
Change from Baseline approximate amount of caffeine used daily. at post-intervention and 4-month follow-up.
Time frame: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline approximate amount use of alcohol and cigarettes daily.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of Mindfulness skills at post-intervention and 4-month follow-up.
Time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Change from Baseline rate of stress and recovery of it at post-intervention and 4-month follow-up.
Time frame: IIt is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Previous experience in practicing of mindfulness and/or meditation
Time frame: It is measured three weeks before the intervention starts.
Amount and quality of independent mindfulness practice
Time frame: Immediately after the 8-week intervention is finished.
Change from post-intervention amount and quality of independent mindfulness practice at 4-month follow-up.
Time frame: Immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 22945032Miller R, Wankerl M, Stalder T, Kirschbaum C, Alexander N. The serotonin transporter gene-linked polymorphic region (5-HTTLPR) and cortisol stress reactivity: a meta-analysis. Mol Psychiatry. 2013 Sep;18(9):1018-24. doi: 10.1038/mp.2012.124. Epub 2012 Sep 4.
- Background: PubMed 29113526Daya Z, Hearn JH. Mindfulness interventions in medical education: A systematic review of their impact on medical student stress, depression, fatigue and burnout. Med Teach. 2018 Feb;40(2):146-153. doi: 10.1080/0142159X.2017.1394999. Epub 2017 Nov 7.
- Results publication: PubMed 29422189Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.
- Derived from this study: PubMed 32691879Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
- Individual participant dataSharing planned: Undecided
Related trials for Well-being
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruiting
Short, Wordless Animated Storytelling to Promote Mental Health Help-Seeking in Young Adults: A U.S. Online Randomized Controlled Trial
Mental Health Help-Seeking
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Active, not recruiting
MEST : A School- Based Health Literacy Intervention Trial
Health Literacy, Adolescent Health
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.
Saara Repo, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face group-based mindfulness and Internet-based mindfulness in people with Well-being and Functional Ability, run by University of Helsinki at 1 site in Finland.
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 7 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 13 Sep 2018. 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 Finland. 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?
Contact Saara Repo, PhD (+358405189456, saara.repo@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. (time frame: It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.). 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 NCT03669016, which also lists 4 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 13 Sep 2018.