Evaluating the Big Five Intervention in Norway

NCT07151573 | Recruiting DMC

• 1 other identifier: 911669
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Anxiety Depression

Keywords

Anxiety; Internet interventions; Big Five; DIgital Mental Health Intervention; Preventive interventions

Outcome Measures

Primary Outcomes (4)

• Generalized Anxiety Disorder- 7

  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.

  At Screening

• Patient Health Questionnaire - 2

  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.

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

• Patient Health Questionnaire - 9

  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.

  At screening

• Generalized Anxiety Disorder - 2

  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.

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

Secondary Outcomes (1)

• Satisfaction With Life Scale

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

Other Outcomes (4)

• Gratitude Questionnaire

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

• Things You Do-15 Questionnaire

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

• Motivation for change in daily life - Questionnaire

  day 8

Study Arms (3)

Big Five

EXPERIMENTAL

Other: Big Five

Gratitude

ACTIVE COMPARATOR

Other: Gratitude

Waitlist

NO INTERVENTION

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

Interventions

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.

Also known as: TYD

Big Five

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.

Gratitude

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PHQ or GAD cutoff 5 or above
• Residing in Norway and have a Norwegian national identity number
• years or above

You may not qualify if:

• Reporting 2 or higher on PHQ item 9 (suicidality concerns)
• Do not comprehend Norwegian or English

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (2)

Research centre for digital mental health services

Bergen, Vestland, 5009, Norway

NOT YET RECRUITING

Research Centre For Digital Mental Health Services - Haukeland University Hospital

Bergen, 5009, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Smiti Kahlon, PhD

CONTACT

+4798866640; smiti.kahlon@helse-bergen.no

Tine Nordgreen, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-armed randomized controlled study

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 3, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: When data collection ends
• Access Criteria: IPD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations

Locations

NO (2)