COVID-19 - No Health Without Mental Health

Anxiety Clinical Trial

— Co-COVID-19  

Official title:

COVID-19 - No Health Without Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421612
• Other study ID #: 126376
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Covid19

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	6 months
Secondary	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.	6 months
Secondary	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	6 months