Covid19Co-COVID-19NCT04421612
COVID-19 - No Health Without Mental Health
A study testing Co-mestring (co-coping) in people with Covid19 and Anxiety, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Co-mestring (co-coping)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteNorway
- Study dates
- 2 Apr 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- read and write norwegian
- above 18 years
- Mild and moderate stress
Who cannot join
- current treatment for mental health disorders
- history or present severe mental health disorder
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Co-mestring (co-coping)
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-mestring (co-coping)Behavioural
8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences
| Study group | Role | What they receive |
|---|---|---|
| Intensive | Experimental | This group recieve access to a new module every 3rd day. Receives: Behavioral: Co-mestring (co-coping) |
| Ordinary | Experimental | This group recieve access to a new module every 5th day. Receives: Behavioral: Co-mestring (co-coping) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Apr 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group one recieve a new module every three days. Group two recive a new module every 5 days.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421612
- Sponsor's protocol ID
- 126376
- Acronym
- Co-COVID-19
- Status last verified
- Aug 2020
- First submitted
- 4 Jun 2020
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is a plan to share anonymous interaction-data. Health data are undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 - No Health Without Mental Health
- ClinicalTrials.gov ID
- NCT04421612
- Acronym / sponsor ID
- Co-COVID-19 / 126376
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group one recieve a new module every three days. Group two recive a new module every 5 days.
| Arm | Type | Receives |
|---|---|---|
| Intensive | Experimental | Behavioral: Co-mestring (co-coping)This group recieve access to a new module every 3rd day. |
| Ordinary | Experimental | Behavioral: Co-mestring (co-coping)This group recieve access to a new module every 5th day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- read and write norwegian
- above 18 years
- Mild and moderate stress
Key exclusion criteria (2 listed)
- current treatment for mental health disorders
- history or present severe mental health disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Intensive, Ordinary |
Primary outcome
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
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
3 secondary outcomes
Positive and negative affect
Time frame: 6 months
Perceived Stress Scale
Time frame: 6 months
Client Satisfaction Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided. There is a plan to share anonymous interaction-data. Health data are undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-mestring (co-coping) in people with Covid19 and Anxiety, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Health Questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.