COVID-19 - No Health Without Mental Health (Co-COVID-19)
Primary Purpose
Covid19, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Co-mestring (co-coping)
Sponsored by

About this trial
This is an interventional supportive care trial for Covid19
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
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intensive
Ordinary
Arm Description
This group recieve access to a new module every 3rd day.
This group recieve access to a new module every 5th day.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Positive and negative affect
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
Perceived Stress Scale
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.
Client Satisfaction Scale
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
Full Information
NCT ID
NCT04421612
First Posted
June 4, 2020
Last Updated
May 5, 2021
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04421612
Brief Title
COVID-19 - No Health Without Mental Health
Acronym
Co-COVID-19
Official Title
COVID-19 - No Health Without Mental Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group one recieve a new module every three days. Group two recive a new module every 5 days.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive
Arm Type
Experimental
Arm Description
This group recieve access to a new module every 3rd day.
Arm Title
Ordinary
Arm Type
Experimental
Arm Description
This group recieve access to a new module every 5th day.
Intervention Type
Behavioral
Intervention Name(s)
Co-mestring (co-coping)
Intervention Description
8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences
Primary Outcome Measure Information:
Title
The Patient Health Questionnaire
Description
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
Time Frame
6 months
Title
The Generalized Anxiety Disorder Scale
Description
measures anxiety severity with seven items scored 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 21
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Positive and negative affect
Description
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
Time Frame
6 months
Title
Perceived Stress Scale
Description
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.
Time Frame
6 months
Title
Client Satisfaction Scale
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5020
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is a plan to share anonymous interaction-data. Health data are undecided
Learn more about this trial
COVID-19 - No Health Without Mental Health
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