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Mental WellbeingNCT06287216

Preliminary Evaluation of a Mental Health Program: a Comparison Study

A study testing Mental Hygiene and Self-Care in people with Mental Wellbeing, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Wellbeing
What is being tested?
Mental Hygiene and Self-Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
29 Feb 2024to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 18 years and above
  • can speak English

Who cannot join

  • Have previously participated in the mental hygiene challenge (exclusion for the control group).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • The Royal

    Ottawa, Ontario, K1Z7K4

    Ottawa, 613-345-1461, guillaume.tremblay@theroyal.ca

    Guillaume Tremblay, NP

    Recruiting

Other trials in Canada

About this study

The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices.

Study investigators also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group.

Read the detailed description

Although mental hygiene is a relatively novel idea, the term can be found in the early 20th century literature. Tremblay et al. {2021) essentially reintroduced the concept and proposed its framework in the scientific literature.

Within public health guidelines, there are standard recommendations given to the public in terms of maintenance of various dimensions of their health. For example, the Canadian Dental Association recommends 2 minutes of teeth brushing twice daily. The World Health Organization (WHO) recommends 150 minutes of moderate physical activity per week for the average adult to support physical health. Showering daily, and frequent hand washing have become embedded in public awareness. As of yet, there is no such well-defined equivalent vis-à-vis mental health in terms of a standardized universal recommendation. Tremblay et al. (2021) proposed a mental hygiene framework that seeks to address this gap and move towards a standardized public facing mental health recommendation equivalent to those that already exist for other dimensions of health. The mental hygiene toolkit is free, accessible and provided through a social equity lens so that anyone from any walk of life can engage in mental wellness without barriers such as cost or availability of time. The preliminary program evaluation findings of the survey data for both years (2022 and 2023) showed a promising signal, which is prompting the investigators to prepare this study that will be built into the 2024 Mental Hygiene Challenge that will involve a control group. It is imperative to continue acquiring empirical data on the impact daily mental hygiene practices has on one's mental wellbeing.

The mental hygiene framework is grounded in 5 main categories of mental training activities. They include: meditation (mindfulness and other techniques), positive psychology interventions, self-directed cognitive behavioral therapy exercises (CBT), pro-social prayer (referring to prayers of thanks and praying for others vs. ritualist/obligatory and supplication prayers), and nature exposure.

The investigators' objective is to gain a better understanding of the impact the mental hygiene challenge has on the wellbeing of its participants for the upcoming Mental Hygiene Challenge of March 2024. In order to do that, the investigators aim to conduct pre-post wellbeing surveys using validated psychometric measures for participants of the challenge. Moreover, the investigators intend to conduct the same pre-post wellbeing survey approach with a control group who will be given standard self-care recommendations. The comparison of the two groups will offer insight on the impact mental hygiene has on those who participate daily.

The investigators overall objective is to determine the impact on mental wellbeing as measured by the WHO-5 and WEMWBS that the mental hygiene challenge of March 2024 will have on its participants. Specifically, the investigators aim to:

  • Test the hypothesis that there is a statistically significant change (increase) in the mental wellbeing scores for those that completed the challenge and participated daily.
  • To test the hypothesis that the change (increase) in pre-post wellbeing scores in the mental hygiene group will be statistically significantly higher compared to any pre-post change in wellbeing scores of the control group.
  • Test the association between participation level and post wellbeing scores. Participation levels will be measured by asking in the post survey how many days they participated in mental hygiene (or self-care) as well as indexing the number of completed daily surveys as an indicator of participation.
Being tested
Mental Hygiene, Self-Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental HygieneBehavioural

    Mental hygiene are daily evidence based practices that support mental wellbeing.

  • Self-CareBehavioural

    Instructed to do 10 minutes of self-care daily.

Study groups in NCT06287216
Study groupRoleWhat they receive
Mental Hygiene GroupExperimentalThis is the group participating in the mental hygiene challenge that is willing to give informed consent and conduct pre-post as well as daily well-being surveys.
Receives: Behavioral: Mental Hygiene
Self-Care GroupActive comparatorSimilar to the above, instead of recommending mental hygiene, the investigators will be recommending daily self-care, and offer standard government issued resources, as well as resources from other reputable organizations.
Receives: Behavioral: Self-Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in level of mental wellbeing as measured by the World Health Organization (WHO)-5 wellbeing index.

    The psychometric index will be collected before and after the 30 days of mental hygiene or self-care. Higher scores indicate better outcomes (min score =0, max score =25).

    Measured: Over approximately a 30 day period.

  2. Change in level of mental wellbeing as measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    The psychometric index will be collected before and after the 30 days of mental hygiene or self-care. Higher scores indicate better outcomes (min score = 14, max score = 70).

    Measured: Over approximately a 30 day period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start29 Feb 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287216
Sponsor's protocol ID
2024001
Status last verified
Mar 2025
First submitted
5 Feb 2024
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mental Hygiene and Self-Care in people with Mental Wellbeing, run by The Royal Ottawa Mental Health Centre 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in level of mental wellbeing as measured by the World Health Organization (WHO)-5 wellbeing index. (time frame: Over approximately a 30 day period.). The study lists 2 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 12 Dec 2025.

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