Evaluating the Big Five Intervention in Norway
Recruiting · NCT07151573 · Interventional (participants receive a specific treatment) · Lead sponsor: Haukeland University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- PHQ or GAD cutoff 5 or above
- Residing in Norway and have a Norwegian national identity number
- 16 years or above
Exclusion criteria
- Reporting 2 or higher on PHQ item 9 (suicidality concerns)
- Do not comprehend Norwegian or English
Where it is running
4 locations listed.
- Research Centre For Digital Mental Health Services - Haukeland University Hospital - Bergen, Norway
- Research Centre For Digital Mental Health Services - Haukeland University Hospital - Bergen, Norway
- Research centre for digital mental health services - Bergen, Vestland, Norway
- Research centre for digital mental health services - Bergen, Vestland, Norway