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Clinical Trials/NCT04421612
NCT04421612
Completed
N/A

COVID-19 - No Health Without Mental Health

Haukeland University Hospital1 site in 1 country91 target enrollmentApril 2, 2020
ConditionsCovid19Anxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Haukeland University Hospital
Enrollment
91
Locations
1
Primary Endpoint
The Generalized Anxiety Disorder Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2020
End Date
January 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Generalized Anxiety Disorder Scale

Time Frame: 6 months

measures anxiety severity with seven items scored 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 21

The Patient Health Questionnaire

Time Frame: 6 months

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

Secondary Outcomes

  • Positive and negative affect(6 months)
  • Perceived Stress Scale(6 months)
  • Client Satisfaction Scale(6 months)

Study Sites (1)

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