Evaluating the Big Five Intervention in Norway

NCT ID: NCT07151573

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three-armed randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Big Five

Group Type EXPERIMENTAL

Big Five

Intervention Type 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.

Gratitude

Group Type ACTIVE_COMPARATOR

Gratitude

Intervention Type 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.

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 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.

Intervention Type 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) 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.

Intervention Type OTHER

Other Intervention Names

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TYD

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research centre for digital mental health services

Bergen, Vestland, Norway

Site Status NOT_YET_RECRUITING

Research Centre For Digital Mental Health Services - Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Smiti Kahlon, PhD

Role: CONTACT

+4798866640

Tine Nordgreen, Professor

Role: CONTACT

Facility Contacts

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Smiti Kahlon, PhD

Role: primary

+47 98866640

Other Identifiers

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911669

Identifier Type: -

Identifier Source: org_study_id

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