NCT07151573

Evaluating the Big Five Intervention in Norway

5 Gode Vaner - En Randomisert Kontrollert Studie

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate the Norwegian adaptation of the Big Five intervention (Things You Do; TYD) for individuals with self-reported anxiety and/or depressive symptoms. The study will compare the Big Five intervention with a Gratitude intervention and a waitlist control. A total of 410 participants will be recruited online and randomized to one of three groups. Intervention groups will receive a brief module and daily SMS reminders (Monday-Friday for four weeks) encouraging engagement in either the five daily actions or gratitude practices. The primary aim is to replicate findings from the Australian trial by comparing TYD to a waitlist control. A secondary aim is to examine whether TYD yields better outcomes than the active Gratitude control. This study will provide evidence on the effectiveness and cross-cultural applicability of a low-cost, scalable intervention for improving mental health. Data from the study will also be used to evaluate the psychometric properties of the Norwegian translation of the Things You Do-15 instrument (TYD-15).

Detailed description

Researchers in Australia have identified five central daily actions that are associated with mental health and may account for 37 % of the variance in anxiety and depressive symptoms: Healthy thinking, Meaningful Activities, Goals and Plans, Healthy Habits, and Social Connections. Conducting these actions more than three to four times a week may improve symptoms of anxiety and depression. Aim: The current study aims to replicate the findings from the Australian developers by adapting the intervention to a Norwegian context in a randomized controlled trial.

Conditions

• Anxiety Depression

Interventions

Type	Name	Description
OTHER	Big Five	The intervention is self-guided and consists of a brief 14-page psychoeducation module that they are introduced to in the beginning of a 4-week intervention period (day 0). The module starts with a general introduction to mental health and Things you do action and how it promotes mental health. The final section presents the five core actions: 1) healthy thinking, 2) meaningful activities, 3) goals and plans, 4) healthy habits, and 5) social connections. Participants are advised to engage in the five daily actions throughout the intervention period. They are also encouraged to fill out a weekly planner and monitor their progress by keeping an overview of the number of daily activities in "My Week".The participants receive the module on a Sunday (Day 0). They receive text reminders Monday to Friday for four weeks, encouraging them to engage in the actions.
OTHER	Gratitude	The intervention is self-guided and consists of a brief 14-page psychoeducation module that they are introduced to in the beginning of a 4-week intervention period (day 0). The module starts with a general introduction to mental health and Gratitude and how it promotes mental health, followed by a short summary on the benefits of gratitude. The final section introduces practical strategies for cultivating gratitude by focusing on five key gratitude activities: 1) keeping a gratitude journal, 2) expressing gratitude to others, 3) finding gratitude in misfortune or difficult situations, 4) appreciating good things and 5) another perspective. The participants receive the module on a Sunday (Day 0). They receive text reminders Monday to Friday for four weeks, encouraging them to engage in the actions.

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-06-30
• Completion: 2027-09-30
• First posted: 2025-09-03
• Last updated: 2025-10-01

Locations

2 sites across 1 country: Norway