Health TrialsbyHealthPanel

Evaluating the Big Five Intervention in Norway

ConditionAnxiety Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHaukeland University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PHQ or GAD cutoff 5 or above

Residing in Norway and have a Norwegian national identity number

16 years or above

Disqualifiers

Reporting 2 or higher on PHQ item 9 (suicidality concerns)

Do not comprehend Norwegian or English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Big Five

    Other intervention

    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

    Other intervention

    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.

Treatment groups

410 Participants
are divided into 3 treatment groups
Group A: Big FiveExperimental treatment 1 intervention
Group B: GratitudeActive comparator 1 intervention
Group C: WaitlistNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At Screening
2

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.

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

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.

Time frame
At screening
4

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.

Time frame
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.

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

Other outcomes

1

Gratitude Questionnaire

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.

Time frame
From pre, peri intervention, post, and follow-up 3, 6 and 12 months
2

Things You Do-15 Questionnaire

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.

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

Motivation for change in daily life - Questionnaire

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

Time frame
day 8
4

Credibility

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.

Time frame
day 8, post

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

The Research Council of Norway

Collaborator

Source ClinicalTrials.gov
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