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NCT Number: NCT07151573

Evaluating the Big Five Intervention in Norway

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).

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Key information

Conditions

Anxiety Depression Anxiety Disorders Mental Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research centre for digital mental health services, Bergen, Vestland, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Big Five

Other

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 names: TYD

Gratitude

Other

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.

Primary outcomes

  1. Generalized Anxiety Disorder- 7

    Time frame: At Screening

    the scale measures measure anxiety symptoms over the last two weeks. The questionnaire consists of seven items on a 4-point Likert Scale ranging from 0 (Not at all) to 3 (Nearly every day), giving a minimum score of 0 and maximum 21. Higher scores indicate more anxiety symptoms.

  2. Patient Health Questionnaire - 2

    Time frame: At pre, day 8, day 15, day 22, post, follow-up 3, 6, and 12 months

    The scale measures depressive symptoms symptoms over the last two weeks. The questionnaire consists of two items on a 4-point Likert Scale ranging from 0 (Not at all) to 3 (Nearly every day), giving a minimum score of 0 and maxiumum 6. Higher scores indicate more depressive symptoms.

  3. Patient Health Questionnaire - 9

    Time frame: At screening

    The scale measures depressive symptoms symptoms over the last two weeks. The questionnaire consists of nineitems on a 4-point Likert Scale ranging from 0 (Not at all) to 3 (Nearly every day), giving a minimum score of 0 and maximum 27. Higher scores indicate more depressive symptoms.

  4. Generalized Anxiety Disorder - 2

    Time frame: At pre, day 8, day 15, day 22, post, follow-up 3, 6, and 12 months

    The scale measures anxiety symptoms symptoms over the last two weeks. The questionnaire consists of two items on a 4-point Likert Scale ranging from 0 (Not at all) to 3 (Nearly every day), giving a minimum score of 0 and maxiumum 6. Higher scores indicate more anxiety symptoms.

Secondary outcomes

  1. Satisfaction With Life Scale

    Time frame: From pre, peri intervention, post, and follow-up 3, 6 and 12 months

    The scale measure subjective well-being and life satisfaction. The questionnaire consists of five items on a 7-point Likert scale ranging from 1 (Strongly disagree) to 7 (Strongly agree), giving a minimum sum score of 5 and maximum 35. Higher scores indicate greater life satisfaction.

Other outcomes

  1. Gratitude Questionnaire

    Time frame: From pre, peri intervention, post, and follow-up 3, 6 and 12 months

    The scale measure their experience of gratitude. The questionnaire consists of 6 items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), with two of the questions being reversed scored, giving a minimum sum score of 6 and a maximum score of 42. Higher scores indicate greater experience of gratitude.

  2. Things You Do-15 Questionnaire

    Time frame: At screening, pre, peri intervention, post, and follow-up 3, 6 and 12 months

    TYD.15 measure their engagement in the daily actions that are associated with emotional wellbeing. The questionnaire comprises of 15 items on a scale from 0 to 4, giving a minimum sum score of 0 and maximum 60. Higher sum scores indicate greater engagement in daily actions.

  3. Motivation for change in daily life - Questionnaire

    Time frame: day 8

    The scale measure their motivation and the importance of making changes in habits, readiness to change, and confidence in that they can make changes. The questionnaire consists of total 4 items on a scale from 1 to 10. Higher score on each item indicate greater motivation

  4. Credibility

    Time frame: day 8, post

    Credibility is a 1-item assessment measuring whether they would recommend the intervention to a friend on a scale from 1 to 9. Higher score indicate greater credibility.

Study contacts

Contact information is provided by the study sponsor or research team.

Smiti Kahlon, PhD

CONTACT

[email protected]

+4798866640

Tine Nordgreen, Professor

CONTACT

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

5 Gode Vaner - En Randomisert Kontrollert Studie

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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