Evaluating the Big Five Intervention in Norway

Haukeland University Hospital

Status: Enrolling

Conditions: Anxiety Depression

Treatments: Other: Big Five; Other: Gratitude

Study type: Interventional

Funder types: Other

Identifiers

NCT07151573

911669

Details and patient eligibility

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).

Full 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.

Enrollment: 410 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

410 participants in 3 patient groups

Big Five

Experimental group

Treatment:

Other: Big Five

Gratitude

Active Comparator group

Treatment:

Other: Gratitude

Waitlist

No Intervention group

Description:

Waitlist during the intervention period, and receive Big Five on week 5.