Evaluating the Big Five Intervention in Norway

Not Applicable

Not yet recruiting

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).

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder- 7	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	From pre, peri-intervention, post, and 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	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	From pre, peri intervention, post, and 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 Outcome Measures

Name	Time	Method
Satisfaction With Life Scale	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.

Locations (1): Research centre for digital mental health services
🇳🇴
Bergen, Vestland, Norway
Research centre for digital mental health services
🇳🇴Bergen, Vestland, Norway

WithdrawnPhase 3

Posted 4/12/2006

Updated 3/10/2015