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Completed

NCT Number: NCT04421612

COVID-19 - No Health Without Mental Health

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).

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Key information

Conditions

Covid19 Anxiety Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Positive and negative affect

    Time frame: 6 months

    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

  2. Perceived Stress Scale

    Time frame: 6 months

    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.

  3. Client Satisfaction Scale

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Acronym: Co-COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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