COVID-19 - No Health Without Mental Health

NCT ID: NCT04421612

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-02
• Study Completion Date: 2021-01-01

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.

Conditions

Covid19; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intensive

This group recieve access to a new module every 3rd day.

Group Type: EXPERIMENTAL

Co-mestring (co-coping)

Intervention Type: BEHAVIORAL

8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences

Ordinary

This group recieve access to a new module every 5th day.

Group Type: EXPERIMENTAL

Co-mestring (co-coping)

Intervention Type: BEHAVIORAL

8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences

Interventions

Co-mestring (co-coping)

8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

126376

Identifier Type: -

Identifier Source: org_study_id