Clinical trial NCT04449627: Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention
Official title: Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety Disorders
Post Traumatic Stress Disorder
Depressive Disorder
Covid19
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2020-06-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were hospitalised with Covid19 who have psychological symptoms 8 weeks after discharge. That is a \>=6 on TSQ or \>= 3 on PHQ9.

Brief summary: Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression.

This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

Detailed description: It is important that the long-term wellbeing of patients who have been admitted with Covid-19 during the pandemic is addressed. A newly published meta analysis (Rogers et al 2020) has looked at the neuropsychiatric consequences of all coronavirus epidemics, including Serious Acute Respiratory Syndrome (SARS) and Middle East Respiratory (MERS) outbreaks, as well as the first emerging studies from SARS-CoV-2. These studies demonstrate that postillness neuropsychiatric complications including anxiety and depression can persist up to 36 months after the original illness. This is a naturalistic cohort trial with a digital intervention. The study population consists of those patients who were admitted with Covid-19, during the SARS-CoV-2 pandemic, who at 8 weeks after discharge were found to have symptoms relating to anxiety and depression. In this context Covid-19 refers to the disease caused by the virus (named SARS-CoV-2). The study population does not include those who required intensive care admission during their stay. Excluding usual community psychiatric services (for example improving access to psychological therapies) and some specialist intensive care follow up services, no interventions at the Royal Free have been set up to address the long-term psychological impacts of admission to hospital with COVID-19. The digital intervention is an app that consists of twelve audio tracks that combine applied relaxation, mindfulness, cognitive behaviour therapy and positive visualisation. It is a validated guided self-help tool for treatment of anxiety and depression in the NHS, and recommended by NHS digital. Participants are asked to listen to one or two tracks daily for the initial 14 days, and as they find beneficial thereafter. They are then followed up, at 2 and 12 weeks, with their anxiety and depression scales (the GAD-7 and PHQ-9). The trial is a single site study that will take place at the Royal Free, with discharged patients in the community

Eligibility criteria: Inclusion criteria

* Over the age of 18
* Treated for Covid-19 at the Royal Free Hospital
* Capacity to consent AND
* At screening had a PHQ-2 score \>=3 (positive) OR
* At screening had a TSQ score \>= 6 (positive)

Exclusion criteria

* A current inpatient
* Participant on alternative trial that excludes being in a secondary trial
* Patient currently using alternative MBCT app tool
* Patients under 18 years old
* Background of psychotic illness
* Patient declined
* Patient unable to consent
* Underlying cognitive impairment which may impede ability to comply with the intervention
* Severe hearing impairment
* Current delirium
* Was an in-patient in intensive care during hospital stay
* Unable to contact patient via telephone on 2 attempts Patient is not registered with a GP. Unable to understand English proficiently enough to engage with the audio tracks.

Primary outcomes:
measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale
timeFrame: Day 14
Secondary outcomes:
measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)
timeFrame: 14 days and week 12
measure: Trauma as measured by Trauma screening questionnaire (TSQ)
timeFrame: 12 weeks
measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale
timeFrame: Week 12
Other outcomes:
measure: Risk associated with distress
timeFrame: Baseline analysis
measure: Qualitative analysis
timeFrame: Baseline
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Research and Development Manager
role: STUDY_CHAIR
References: