Stress, PsychologicalNCT04612387
Online Wellness Intervention in Medical Students
A study testing Mind-body therapy in people with Stress, Psychological and Mind Body Therapy, run by University of Alberta at 1 site in Canada.
Trial summary
Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological, Mind Body Therapy, Wellbeing
- What is being tested?
- Mind-body therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2020to 30 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical students in any year of medical school
Who cannot join
- Hospital Anxiety and Depression Scale (HADS) Depression score >10
- Active psychosis
- Post-traumatic stress disorder or frequent suicidal ideation
- Major medical co-morbidity
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study
Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. The program is delivered online and each week is made of an introduction video, 7-8 minutes of yoga, 5-7 minutes of meditation and nutrition tips. At the beginning and the end of the 12-week research study, we will be using surveys to ask students about their stress, anxiety, depression, sense of control over their own life, quality of life, and pain levels. After the program, the research team will conduct interviews with the medical student to allow them to share their other feedback about the program. The researchers will also send surveys to the medical students one month after the program ends to asses their continued satisfaction with and adherence to the program.
- Conditions
- Stress, Psychological, Mind Body Therapy, Wellbeing
- Being tested
- Mind-body therapy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body therapyBehavioural
Online yoga, meditation and nutrition tips.
| Study group | Role | What they receive |
|---|---|---|
| Mind-body Intervention arm | Experimental | Online yoga, meditation and nutrition tips. Receives: Behavioral: Mind-body therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The degree to which situations in one's life are appraised as stressful will be assessed using the Perceived Stress Scale. The minimum score is 0, the maximum score is 40, and higher scores indicate a worse outcome.
Measured: 12 weeks
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) will be used to measure depression. The minimum score is 0, the maximum is 27, and higher scores indicate a worse outcome.
Measured: 12 weeks
Psychological Wellbeing Scale
The Psychological Wellbeing Scale will be sued to measure well being. Higher scores mean higher levels of psychological well-being
Measured: 12 weeks
Five Facet Mindfulness Questionnaire
Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire.
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start25 Oct 2020
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612387
- Sponsor's protocol ID
- Pro00098576
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study
- ClinicalTrials.gov ID
- NCT04612387
- Acronym / sponsor ID
- Pro00098576
- Conditions
- Stress, Psychological, Mind Body Therapy, Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Nov 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.
Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. The program is delivered online and each week is made of an introduction video, 7-8 minutes of yoga, 5-7 minutes of meditation and nutrition tips. At the beginning and the end of the 12-week research study, we will be using surveys to ask students about their stress, anxiety, depression, sense of control over their own life, quality of life, and pain levels. After the program, the research team will conduct interviews with the medical student to allow them to share their other feedback about the program. The researchers will also send surveys to the medical students one month after the program ends to asses their continued satisfaction with and adherence to the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mind-body Intervention arm | Experimental | Behavioral: Mind-body therapyOnline yoga, meditation and nutrition tips. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students in any year of medical school
Key exclusion criteria (5 listed)
- Hospital Anxiety and Depression Scale (HADS) Depression score >10
- Active psychosis
- Post-traumatic stress disorder or frequent suicidal ideation
- Major medical co-morbidity
- Inability to provide written informed consent
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 |
|---|---|---|
| Mind-body therapyOnline yoga, meditation and nutrition tips. | Behavioural | Mind-body Intervention arm |
Primary outcome
Perceived Stress Scale
Time frame: 12 weeks
The degree to which situations in one's life are appraised as stressful will be assessed using the Perceived Stress Scale. The minimum score is 0, the maximum score is 40, and higher scores indicate a worse outcome.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 12 weeks
Psychological Wellbeing Scale
Time frame: 12 weeks
Five Facet Mindfulness Questionnaire
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body therapy in people with Stress, Psychological and Mind Body Therapy, run by University of Alberta at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 5 Apr 2022. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Scale (time frame: 12 weeks). 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 5 Apr 2022.