COVID-19 - No Health Without Mental Health

NCT04421612 | Completed

• 1 other identifier: 126376
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Positive and negative affect

  6 months

• Perceived Stress Scale

  6 months

• Client Satisfaction Scale

  6 months

Study Arms (2)

Intensive

EXPERIMENTAL

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

Behavioral: Co-mestring (co-coping)

Ordinary

EXPERIMENTAL

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

Behavioral: Co-mestring (co-coping)

Interventions

Co-mestring (co-coping) BEHAVIORAL

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

Intensive; Ordinary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• read and write norwegian
• above 18 years
• Mild and moderate stress

You may not qualify if:

• current treatment for mental health disorders
• history or present severe mental health disorder

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group one recieve a new module every three days. Group two recive a new module every 5 days.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: April 2, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2020-08

Locations

NO (1)