Anxiety DepressionNCT07151573
Evaluating the Big Five Intervention in Norway
A study testing Big Five and Gratitude in people with Anxiety Depression, run by Haukeland University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Big Five and Gratitude
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesNorway
- Study dates
- 10 Sep 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PHQ or GAD cutoff 5 or above
- Residing in Norway and have a Norwegian national identity number
- 16 years or above
Who cannot join
- Reporting 2 or higher on PHQ item 9 (suicidality concerns)
- Do not comprehend Norwegian or English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tine Nordgreen, Professor contact
Norway2 sites, 2 recruiting
- Not yet recruiting
Research centre for digital mental health services
Bergen, Vestland, 5009
- Recruiting
Research Centre For Digital Mental Health Services - Haukeland University Hospital
Bergen, 5009
Smiti Kahlon, PhD, +47 98866640
Smiti Kahlon, PhD
About this study
Official title: 5 Gode Vaner - En Randomisert Kontrollert Studie
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).
Read the 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.
- Conditions
- Anxiety Depression
- Being tested
- Big Five, Gratitude
- Keywords
- Anxiety, Internet interventions, Big Five, DIgital Mental Health Intervention, Preventive interventions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Big FiveOther
Also called TYD
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.
GratitudeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Big Five | Experimental | Not described Receives: Other: Big Five |
| Gratitude | Active comparator | Not described Receives: Other: Gratitude |
| Waitlist | No intervention | Waitlist during the intervention period, and receive Big Five on week 5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At pre, day 8, day 15, day 22, post, follow-up 3, 6, and 12 months
Secondary outcomes (1)
Satisfaction With Life Scale
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.
Measured: From pre, peri intervention, post, and follow-up 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start10 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-armed randomized controlled study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151573
- Sponsor's protocol ID
- 911669
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Gode Vaner - En Randomisert Kontrollert Studie
- ClinicalTrials.gov ID
- NCT07151573
- Acronym / sponsor ID
- 911669
- Conditions
- Anxiety Depression
- Keywords
- Anxiety, Internet interventions, Big Five, DIgital Mental Health Intervention, Preventive interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three-armed randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PHQ or GAD cutoff 5 or above
- Residing in Norway and have a Norwegian national identity number
- 16 years or above
Key exclusion criteria (2 listed)
- Reporting 2 or higher on PHQ item 9 (suicidality concerns)
- Do not comprehend Norwegian or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Big FiveAlso: TYDThe 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 | Big Five |
| GratitudeThe 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. | Other | Gratitude |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Satisfaction With Life Scale
Time frame: From pre, peri intervention, post, and follow-up 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tine Nordgreen, Professor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Big Five and Gratitude in people with Anxiety Depression, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smiti Kahlon, PhD (+4798866640, smiti.kahlon@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder- 7 (time frame: At Screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.