NCT04784871

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
970

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 25, 2021

Last Update Submit

March 22, 2023

Conditions

WellbeingHealth AttitudeQuality of Life

Keywords

WellbeingHealth promotionWeb-based intervention

Outcome Measures

Primary Outcomes (2)

  • Wellbeing (Subjective wellbeing, global life satisfaction)

    Satisfaction With Life Scale (Diener, 2009) Scoring: 31 - 35 Extremely satisfied, 26 - 30 Satisfied, 21 - 25 Slightly satisfied, 20 Neutral,15 - 19 Slightly dissatisfied, 10 - 14 Dissatisfied and 5 - 9 Extremely dissatisfied

    12 months

  • Wellbeing (Psychological wellbeing, self-perceived success in different aspects of life)

    Flourishing Scale (Diener et. al 2009). Scores from 8 (lowest possible wellbeing) to 56 (highest possible wellbeing).

    12 months

Secondary Outcomes (4)

  • Mastery

    12 months

  • Mental health (symptoms of depression and anxiety,)

    12 months

  • Social life

    12 months

  • Physical health

    12 months

Other Outcomes (5)

  • Work participation

    12 months

  • Five ways to wellbeing- activities: connect, keep learning, take notice and give.

    12 months

  • Five ways to wellbeing- activity: be active. Frequency, duration and intensity.

    12 months

  • +2 more other outcomes

Study Arms (3)

5waysA Intervention

EXPERIMENTAL

The intervention, 5WaysA, is a 10 week modified web-based version of the original Five Ways to Wellbeing course. The intervention consists of a two-hour main webinar with live lecturing from a facilitator introducing the Five Ways to Wellbeing framework and teaching the participants how to implement the five health promotive activities in life, a booster session webinar four weeks later, as well as an SMS message twice a week in the six following weeks. Each SMS encourages participants to engage in one of the five activities, register activities/goals and queries about the degree of participation in the activity introduced in the previous SMS.

Behavioral: 5waysA Intervention

5waysA Active wait-list control

OTHER

The active wait-list control group will get the same intervention as the interventions group, five months later. The active wait-list control group will be encouraged (in SMS messages) to write down an activity log once a week in ten weeks, while waiting. The participants in this group will also answer questionnaires after the intervention group has finished the intervention

Behavioral: 5waysA Active wait-list control

5waysA Inactive wait-list control

OTHER

The inactive wait-list control group will get the same intervention as the interventions group, five months later. The inactive wait-list control group will not do anything specific while waiting for the intervention. The participants in this group will also answer questionnaires after the intervention group has finished the intervention

Behavioral: 5waysA Inactive wait-list control

Interventions

5waysA InterventionBEHAVIORAL

Web-based 10 week intervention, encouraging participants engaging in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

5waysA Intervention
5waysA Active wait-list controlBEHAVIORAL

Writing activity log in the waiting time. Then, after five months and the writing of activity log, the participants get the web-based intervention and SMS massages, which encourage the participants to engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

5waysA Active wait-list control
5waysA Inactive wait-list controlBEHAVIORAL

No activity while the participants wait. After five months of waiting, the participants get the web-based intervention and SMS messages, which encourage participants engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

5waysA Inactive wait-list control

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years old

You may not qualify if:

  • under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monica Beer Prydz

Asker, Norge, 1397, Norway

Location

Related Publications (1)

  • Prydz MB, Czajkowski NO, Eilertsen M, Roysamb E, Nes RB. A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial. JMIR Ment Health. 2024 May 20;11:e49050. doi: 10.2196/49050.

    PMID: 38767958DERIVED

Study Officials

  • Monica B Prydz, Cand.psychol

    University of Oslos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 5, 2021

Study Start

March 4, 2021

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)