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Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04449627
Acronym
FeelGood
Enrollment
125
Registered
2020-06-29
Start date
2020-08-31
Completion date
2021-01-31
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Covid19, Depressive Disorder, Post Traumatic Stress Disorder

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

Interventions

OTHERFeeling Good Digital App

Audio based tracks using Jacobson relaxation and mindfullness based cognitive therapy (MBCT) techniques including positive visualisation.

Sponsors

University College, London
CollaboratorOTHER
Royal Free Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety as measured by generalised anxiety disorder score (GAD-7) scaleDay 14Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Secondary

MeasureTime frameDescription
Depression as measured by the patient health questionnaire 9 (PHQ-9)14 days and week 12The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.
Trauma as measured by Trauma screening questionnaire (TSQ)12 weeksThe Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.
Anxiety as measured by generalised anxiety disorder score (GAD-7) scaleWeek 12Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Other

MeasureTime frameDescription
Risk associated with distressBaseline analysisRisk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.
Qualitative analysisBaselineFramework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Contacts

Primary ContactJoanna Dobbin, MScMBBS
j.dobbin@nhs.net07833457884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026