COVID-19 - No Health Without Mental Health

Study Overview
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Brief Summary
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The Corona pandemic is affecting the whole world and since March 12.th 2020 there has been strict qurantene and social isolation interventions in Norway. The aim of this intervention is to reduce the negative and fatal effects of the pandemic. The pandemic and the restrictions that follows it is assumed to affect the mental health of the general population. In this research project we want to examine the use and the effects of a digital self-guided psychological intervention with the aim to increase coping and to reduce psychological problems during and after the pandemic. The participants will be randomized to either an intensive group (new module every 3rd day) or to an ordinary group (new module every 5th day).

Detailed Description
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The intervention was developed in a crossdiciplinary and cross-sectorial team within the framework of the research project INTROMAT, an ICT Lighthouse research project funded by the Norwegian Research Council. The content of the digital covid-19 intervention was based on four previously developed digital interventions, all based on systematic user-involvement and user-testing, from our group. The person-based approach inspired the development of the intervention. Based on the research literature and experience from our existing digital interventions we started the development with establishing guiding principles. The intervention consists of 8 modules.

Official Title
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COVID-19 - No Health Without Mental Health

Conditions
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Covid19, Anxiety

Intervention / Treatment
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* Behavioral: Co-mestring (co-coping)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: read and write norwegian above 18 years Mild and moderate stress Exclusion Criteria: current treatment for mental health disorders history or present severe mental health disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group one recieve a new module every three days. Group two recive a new module every 5 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive<br>This group recieve access to a new module every 3rd day. | Behavioral: Co-mestring (co-coping)<br>* 8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences<br>|
| Experimental: Ordinary<br>This group recieve access to a new module every 5th day. | Behavioral: Co-mestring (co-coping)<br>* 8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire | measures depression severity with nine items scored 0 (not at all) to 3 (nearly every day), corresponding to the criteria for major depression in the DSM-5. The sum of the scores for the nine items ranges from 0 to 27 | 6 months | 
| The Generalized Anxiety Disorder Scale | measures anxiety severity with seven items scored 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative affect | In the instructions to the PANAS scales in the current study, participants were asked, ''To what extent do you generally feel this way, that is, how do you feel on average?'' Each PANAS scale comprises 10 specific mood-related adjectives, rated on a 5-point scale from not at all to very much | 6 months | 
| Perceived Stress Scale | Widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. | 6 months | 
| Client Satisfaction Scale | structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction | 6 months |