Skip to content

COVID-19 - No Health Without Mental Health

COVID-19 - No Health Without Mental Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421612
Acronym
Co-COVID-19
Enrollment
91
Registered
2020-06-09
Start date
2020-04-02
Completion date
2021-01-01
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Covid19

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.

Interventions

BEHAVIORALCo-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

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Patient Health Questionnaire6 monthsmeasures 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
The Generalized Anxiety Disorder Scale6 monthsmeasures anxiety severity with seven items scored 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21

Secondary

MeasureTime frameDescription
Positive and negative affect6 monthsIn 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
Perceived Stress Scale6 monthsWidely 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.
Client Satisfaction Scale6 monthsstructured 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026