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

NCT04449627 | Unknown

• 1 other identifier: RoyalFreeNHS
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

  Generalised 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.

  Day 14

Secondary Outcomes (3)

• Depression as measured by the patient health questionnaire 9 (PHQ-9)

  14 days and week 12

• Trauma as measured by Trauma screening questionnaire (TSQ)

  12 weeks

• Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

  Week 12

Other Outcomes (2)

• Risk associated with distress

  Baseline analysis

• Qualitative analysis

  Baseline

Study Arms (1)

Naturalistic cohort

Patients who were hospitalised between March and June from Covid19, who did not require treatment in intensive care, who at 8 weeks post discharge have symptoms of anxiety or depression. All patients are offered access to an audio based self help programme based on applied relaxation and mindfulness based cognitive therapy.

Other: Feeling Good Digital App

Interventions

Feeling Good Digital App OTHER

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

Naturalistic cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• University College, London: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mood Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Research and Development Manager

  Sponsor GmbH

  STUDY CHAIR

Central Study Contacts

Joanna Dobbin, MScMBBS

CONTACT

07833457884; j.dobbin@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 29, 2020
• Study Start: August 31, 2020
• Primary Completion: October 31, 2020
• Study Completion: January 31, 2021
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share