Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784871
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2021-02-25
Brief Title:
Promoting Wellbeing The Five Ways to All Intervention
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Promoting Wellbeing A Randomized Controlled Trial of the Five Ways to All Intervention
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5WaysA
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 ie 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 ie 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 ie 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 ie is the effect moderated by eg gender age education
2 What mechanisms eg 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 n750 or to one of two wait-list control groups active control n375 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 GPower3 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 f01 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
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 ie 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 ie 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 ie is the effect moderated by eg gender age education
2 What mechanisms eg 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 n750 or to one of two wait-list control groups active control n375 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 GPower3 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 f01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None