Clinical trial NCT04784871: Promoting Wellbeing: The Five Ways to All Intervention
Official title: Promoting Wellbeing: A Randomized Controlled Trial of the Five Ways to All Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellbeing
Health Attitude
Quality of Life
Keywords: Wellbeing
Health promotion
Web-based intervention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Norwegian Council for Mental Health
name: The Dam Foundation
First posted: 2021-03-05
Enrollment: 970
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a randomized controlled trial (RCT) with one intervention group and two wait-list control groups. The goal with this design is to demonstrate the initial efficacy and feasibility of the 5WaysA intervention. We have one active control group writing activity log and one inactive not getting any tasks while waiting. The effect analysis will involve a comparison of self-reported wellbeing at different measurement points, using a two-way mixed measures ANOVA. In addition, PI will run a longitudinal analysis using linear mixed (multilevel) models on the data from all 5-6 measurement time points. Mixed modelling is a flexible way to handle unbalanced data in case of non-registration and repeated observations. The models allow PI to investigate the effects of the intervention and test the hypotheses of group and individual development in wellbeing while controlling for both stable and time-varying covariates.
Primary purpose: PREVENTION

Brief summary: This project is funded by Stiftelsen Dam and is a cooperation between The Norwegian Council for Mental Health (NCMH) and PROMENTA research group at the University of Oslo. Low-cost and evidence-based health promoting public health tools are urgently needed in Norwegian municipalities, to meet both current and future challenges with mental health and wellbeing. The aim in this randomized controlled trail is to test if a shorter, 10 week web-based version (The Five Ways to All, "5WaysA"), of an already established course (Five Ways to Wellbeing course), can promote wellbeing and mastery in the general population. The principal investigator will investigate to what extend the effects are short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention).

Detailed description: Background:

The need for effective, low-cost and evidence-based tools to prevent illness and promote health in the population is paramount. Norway, along with other countries in the Western world, is currently facing major health and welfare-related challenges. Demographic changes, lifestyle related diseases and work absence are threatening the sustainability of the Norwegian welfare state. Non-communicable diseases, including mental illness, currently account for 65% of the total disease burden in Norway and 50% of Norwegians are likely to meet diagnostic criteria for a mental disorder some time during their life span. Traditional treatment and care options tend to be costly and time consuming, and to depend on highly skilled specialist human resources. Systematic findings also indicate that population-based (i.e., universal, targeting the general population) measures often result in larger population health gains than selective and indicated measures targeting only those with excess risk. According to the paradox of prevention, when disease risk is common, universal interventions directed towards the whole population before illness occurs, are more effective than interventions targeting high risk groups after symptoms have emerged. The Covid-19 pandemic and associated social distancing measures have corroborated the need for digital solutions. Web-based interventions may reach a large number of participants, utilizing a very modest amount of both human and financial resources.

The aim:

This study aims to test a potentially effective low-cost health and wellbeing promotive web-based intervention targeting the general population in Norwegian municipalities. The intervention is based on the Five Ways to Wellbeing framework developed for British health authorities in 2008. This framework, and the intervention to be tested, provides participants with knowledge on simple, sustainable activities that may strengthen their subjective wellbeing (SWB), mastery, health and social relations, thereby also reducing the risk of common mental health problems such as depression and anxiety. The study will be conducted in close collaboration with municipal stakeholders and important user groups. Thus, the principal investigator (PI) will investigate effects of a low-cost health and wellbeing promotive public health tool based on the evidence-base of Five Ways to Wellbeing. To date, nobody has tested the Five Ways-concept in such a format. Proved effective, this web-based 5WaysA intervention, may have a significant impact on the public health of inhabitants in the municipalities.

Main hypothesis:

The web-based intervention 5WaysA will improve wellbeing and mastery and hence provide the municipalities with an effective measure for mental health promotion.

Research questions:

1. To what extent does participation in the web-based 5WaysA intervention lead to improved wellbeing, mental health and mastery in the general population?
2. To what extent are the effects short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention)?
3. What mechanisms explain potential improvements in wellbeing?

   1. For whom is this intervention effective (i.e., is the effect moderated by e.g. gender, age, education)?
   2. What mechanisms (e.g., regular practicing of 5Ways actions, increased social activity or support) explain intervention effects?

Sample and recruitment:

The PI plan to recruit a minimum of 1500 participants from the general population in Norwegian municipalities. The participants will be randomized to either an intervention group (n=750), or to one of two wait-list control groups (active control, n=375) (inactive control, n =375). The wait-list control groups will receive the intervention three to five months later. The PI expect high drop-out (up to 50 %) since this has been the situation in other studies investigating online interventions in a general population. The PI is also unsure about how much time the municipalities have to help PI with the recruitment process, because of a high work load in the municipalities during the pandemic of Covid-19.

Note (June 19, 2021): PI was only able to recruit 226 participants in spring 2021. PI will continue the recruitment process and do another round of the intervention in fall 2021. This will not be registered as a new study, and is regarded as part of the current study

Procedures:

The web-based 10 week intervention consist of one main webinar (two hours at Zoom), a booster session webinar five weeks later and SMS messages twice a week in the the six following weeks. The webinars will be live lectures with an independent trained facilitator. The SMS messages will be sent out by the PI (via Nettskjema) to all participants while they are in the interventions period. Questionnaires will be administrated and distributed by the PI by using the Nettskjema and Services for sensitive data (TSD) tools. The measurements will also be conducted use of Nettskjema and TSD.

Power analysis:

The PI assume that we can recruit a minimum of 1500 participants, but high drop-out is expected. An a priori power analysis was conducted using G\*Power3 to test the interaction effect in a mixed ANOVA, using a two-tailed test, assuming a small effect size (f = .10), and an alpha of .05. The assumed effect size (f=0.1) was chosen as it is of the same magnitude (lower bound) as has been reported by other universal interventions with wellbeing as the outcome measure. The result showed that if PI attained a total sample of 750 participants at the second measurement point (attrition of 50%), PI would have power of .999 to detect a group by time interaction. The high level of statistical power will enable PI to investigate both moderators and mediators of the treatment effect.

Eligibility criteria: Inclusion Criteria:

* over 18 years old

Exclusion Criteria:

* under 18 years old

Primary outcomes:
measure: Wellbeing (Subjective wellbeing, global life satisfaction)
timeFrame: 12 months
measure: Wellbeing (Psychological wellbeing, self-perceived success in different aspects of life)
timeFrame: 12 months
Secondary outcomes:
measure: Mastery
timeFrame: 12 months
measure: Mental health (symptoms of depression and anxiety,)
timeFrame: 12 months
measure: Social life
timeFrame: 12 months
measure: Physical health
timeFrame: 12 months
Other outcomes:
measure: Work participation
timeFrame: 12 months
measure: Five ways to wellbeing- activities: connect, keep learning, take notice and give.
timeFrame: 12 months
measure: Five ways to wellbeing- activity: be active. Frequency, duration and intensity.
timeFrame: 12 months
measure: Basic feelings
timeFrame: 12 months
measure: Optimistic about the future
timeFrame: 12 months
Locations:
city: Asker
country: Norway
facility: Monica Beer Prydz
state: Norge
Study officials:
affiliation: University of Oslos
name: Monica B Prydz, Cand.psychol
role: PRINCIPAL_INVESTIGATOR
References: