Evaluating the Big Five Intervention in Norway
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Big Five, Gratitude.
- Who it may be relevant to
- Registry conditions: Anxiety Depression. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
5 Gode Vaner - En Randomisert Kontrollert Studie
Overview
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.
Interventions
- 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 - 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)
Primary outcome measures
- Generalized Anxiety Disorder- 7 [Time frame: At Screening]
- Patient Health Questionnaire - 2 [Time frame: At pre, day 8, day 15, day 22, post, follow-up 3, 6, and 12 months]
- Patient Health Questionnaire - 9 [Time frame: At screening]
- Generalized Anxiety Disorder - 2 [Time frame: At pre, day 8, day 15, day 22, post, follow-up 3, 6, and 12 months]
Secondary outcome measures (1)
- Satisfaction With Life Scale [Time frame: From pre, peri intervention, post, and follow-up 3, 6 and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Norway · 2 centers
- Research centre for digital mental health services — Bergen
- Research Centre For Digital Mental Health Services - Haukeland University Hospital — Bergen
Identifiers
NCT: NCT07151573 · 911669