Actively Recruiting
5 Gode Vaner - En Randomisert Kontrollert Studie Evaluating the Norwegian Big Five Intervention for Anxiety and Depression
Led by Haukeland University Hospital · Updated on 2025-10-01
410
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
T
The Research Council of Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Norwegian adaptation of the Big Five intervention, called Things You Do (TYD), for individuals experiencing self-reported symptoms of anxiety and depression. This randomized controlled trial aims to replicate findings from an Australian study by comparing TYD to a waitlist control group and an active Gratitude intervention. The study will also assess the Norwegian version of the TYD-15 instrument for measuring daily actions related to mental health. Participants will be randomly assigned to one of three groups: the Big Five intervention, the Gratitude intervention, or a waitlist control. Both intervention groups receive a brief 14-page psychoeducation module at the start of a 4-week period. They will get daily text reminders Monday through Friday encouraging engagement in either the five core daily actions or gratitude practices. The waitlist group will receive the Big Five intervention after the initial 4 weeks. During the study, participants will complete assessments including the Generalized Anxiety Disorder scales (GAD-7 and GAD-2) and the Patient Health Questionnaire (PHQ-2 and PHQ-9) at multiple time points from screening through 12 months follow-up. The Satisfaction With Life Scale will also be used. This study will monitor participant progress through weekly planners and self-report, with the total participation lasting up to a year for follow-up evaluations.
CONDITIONS
Brief Title
Evaluating the Big Five Intervention in Norway
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PHQ or GAD score of 5 or above
- Living in Norway with a Norwegian national identity number
- Age 16 years or older
You will not qualify if you...
- Reporting a score of 2 or higher on PHQ item 9 indicating suicidal thoughts
- Not understanding Norwegian or English
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 4 weeks
Participants receive a self-guided psychoeducation module introducing daily mental health actions. They engage in these actions and receive text reminders Monday to Friday for four weeks to encourage participation.
1 baseline visit and weekly check-ins via text reminders
Duration - Up to 12 months
Participants are monitored for ongoing effects of the intervention with assessments at multiple timepoints after treatment ends.
Visits at 3, 6, and 12 months post-intervention
Trial Site Locations
Total: 2 locations
1
Research centre for digital mental health services
Bergen, Vestland, Norway, 5009
Not Yet Recruiting
2
Research Centre For Digital Mental Health Services - Haukeland University Hospital
Bergen, Norway, 5009
Actively Recruiting
Research Team
S
Smiti Kahlon, PhD
T
Tine Nordgreen, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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