Mental Health Wellness 1NCT05772650
The Online Mood Booster Challenge to Support Physical and Mental Health
An observational study of Mental Health Wellness 1, run by McGill University at 1 site in Canada.
Trial summary
Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- e-Health Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2023to 30 Jun 2023
- Phase
- Observational
- 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
Study population: McGill University faculty, staff, students and invited family members
Who may be able to join
- Affiliated with McGill University or family member
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, h3a 0g4
Dr. Steven Grover, MD, 514-791-5688, steven.grover@mcGill.ca
Violette Berberian, B.S.C., MBA, 514-715-2827, violette.berberian@affiliate.mcgill.ca
About this study
Official title: Healthier Together Mood Booster Challenge
Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.
Read the detailed description
An 8-week web-based health promotion program to learn strategies and use digital tools that will give participants a physical, mental, and emotional boost, with exercise remaining a key component of the mission.
Each week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health.
Techniques will be focused on: spending time exercising outdoors, practicing daily gratitude, practicing good posture, building social connection, deep breathing, listening to music, limiting time on social media and focusing on better sleep.
- Conditions
- Mental Health Wellness 1
- Being tested
- e-Health Program
- Keywords
- web based health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Health ProgramBehavioural
Lifestyle modification for health and disease management using digital solutions
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physical Activity Levels
8 week program to create healthy habits of incorporating increased physical activity in daily life.
Self-reported physical activity levels using the International Physical Activity Questionnaire (IPAQ) (weekly metabolic equivalents (METs); using an estimate of 4 METs/ min moderate exercise and 8 METs/ min vigorous exercise)
Measured: Feb 20 - April 16, 2023
Adherence to Program
8 Week program to help change behaviour for healthy habit creation. Adherence will be measured as the number of days tracking physical activity levels and answering the behaviour change questions.
Less than 7 days = very poor adherence 7-21 days = poor adherence 22-42 days = moderate adherence 43-49 days = good adherence Greater than 49 days = excellent adherence
Measured: Feb 20 - April 16, 2023
Improvement in Stress
The following methodology will be used to measure the above metric:
- Stress score - Perceived Stress Scale. 10 questions; Total score from 0 to 40; ≥18 high stress (1 standard deviation above the mean)
Measured: Feb 20 - April 16, 2023
Improvement in Sleep
The following methodology will be used to measure the above metric:
- Sleep score - Insomnia Severity Index. 7 questions; Total score from 0 to 28; ≥ 8 subthreshold insomnia
Measured: Feb 20 - April 16, 2023
Improvement in Mood
The following methodology will be used to measure the above metric:
- Depression score - Centre for Epidemiological Studies - Depression questionnaire 20 questions; Total score 0-40; ≥16 subthreshold depressive symptoms
Measured: Feb 20 - April 16, 2023
Improvement in Burnout
The following methodology will be used to measure the above metric:
- Burnout - Oldenburg burnout assessment. <2.89 no or little sign of burnout; 2.89 to 3.51 may be at risk of burnout; >3.51 at very high risk of burnout
Measured: Feb 20 - April 16, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start6 Feb 2023
- Primary completion16 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Grover, MD, McGill University
- Investigators
- Dr. Steven Grover, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772650
- Sponsor's protocol ID
- CLIN1903
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregate data analysis
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthier Together Mood Booster Challenge
- ClinicalTrials.gov ID
- NCT05772650
- Acronym / sponsor ID
- CLIN1903
- Conditions
- Mental Health Wellness 1
- Keywords
- web based health promotion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 16 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Mar 2023 (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.
Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.
Detailed description
An 8-week web-based health promotion program to learn strategies and use digital tools that will give participants a physical, mental, and emotional boost, with exercise remaining a key component of the mission.
Each week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health.
Techniques will be focused on: spending time exercising outdoors, practicing daily gratitude, practicing good posture, building social connection, deep breathing, listening to music, limiting time on social media and focusing on better sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- McGill University faculty, staff, students and invited family members
Key inclusion criteria (1 listed)
- Affiliated with McGill University or family member
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| e-Health ProgramLifestyle modification for health and disease management using digital solutions | Behavioural | – |
Primary outcome
Improvement in Physical Activity Levels
Time frame: Feb 20 - April 16, 2023
8 week program to create healthy habits of incorporating increased physical activity in daily life. Self-reported physical activity levels using the International Physical Activity Questionnaire (IPAQ) (weekly metabolic equivalents (METs); using an estimate of 4 METs/ min moderate exercise and 8 METs/ min vigorous exercise)
Adherence to Program
Time frame: Feb 20 - April 16, 2023
8 Week program to help change behaviour for healthy habit creation. Adherence will be measured as the number of days tracking physical activity levels and answering the behaviour change questions. Less than 7 days = very poor adherence 7-21 days = poor adherence 22-42 days = moderate adherence 43-49 days = good adherence Greater than 49 days = excellent adherence
Improvement in Stress
Time frame: Feb 20 - April 16, 2023
The following methodology will be used to measure the above metric: - Stress score - Perceived Stress Scale. 10 questions; Total score from 0 to 40; ≥18 high stress (1 standard deviation above the mean)
Improvement in Sleep
Time frame: Feb 20 - April 16, 2023
The following methodology will be used to measure the above metric: - Sleep score - Insomnia Severity Index. 7 questions; Total score from 0 to 28; ≥ 8 subthreshold insomnia
Improvement in Mood
Time frame: Feb 20 - April 16, 2023
The following methodology will be used to measure the above metric: - Depression score - Centre for Epidemiological Studies - Depression questionnaire 20 questions; Total score 0-40; ≥16 subthreshold depressive symptoms
Improvement in Burnout
Time frame: Feb 20 - April 16, 2023
The following methodology will be used to measure the above metric: - Burnout - Oldenburg burnout assessment. <2.89 no or little sign of burnout; 2.89 to 3.51 may be at risk of burnout; >3.51 at very high risk of burnout
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided. Aggregate data analysis
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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.
Dr. Steven Grover, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1, run by McGill University 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 0 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 16 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Steven Grover, MD (514-846-7973 ext. 223, steven.grover@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Physical Activity Levels (time frame: Feb 20 - April 16, 2023). The study lists 6 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 16 Mar 2023.