Anxiety DisordersFeelGoodNCT04449627
Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention
An observational study of Anxiety Disorders and Post Traumatic Stress Disorder, run by Royal Free Hospital NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Post Traumatic Stress Disorder, Depressive Disorder
- What is being tested?
- Feeling Good Digital App
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2020to 31 Jan 2021
- Phase
- Observational
- 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
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Feeling Good Digital App
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depressive Disorder, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeling Good Digital AppOther
Audio based tracks using Jacobson relaxation and mindfullness based cognitive therapy (MBCT) techniques including positive visualisation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Feeling Good Digital App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (3)
Depression as measured by the patient health questionnaire 9 (PHQ-9)
The 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.
Measured: 14 days and week 12
Trauma as measured by Trauma screening questionnaire (TSQ)
The 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.
Measured: 12 weeks
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start31 Aug 2020 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Research and Development Manager, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449627
- Sponsor's protocol ID
- RoyalFreeNHS
- Acronym
- FeelGood
- Status last verified
- Aug 2020
- First submitted
- 11 Jun 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention
- ClinicalTrials.gov ID
- NCT04449627
- Acronym / sponsor ID
- FeelGood / RoyalFreeNHS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 29 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naturalistic cohort | – | Other: Feeling Good Digital AppPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Feeling Good Digital AppAudio based tracks using Jacobson relaxation and mindfullness based cognitive therapy (MBCT) techniques including positive visualisation. | Other | Naturalistic cohort |
Primary outcome
Anxiety as measured by generalised anxiety disorder score (GAD-7) scale
Time frame: Day 14
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.
3 secondary outcomes
Depression as measured by the patient health questionnaire 9 (PHQ-9)
Time frame: 14 days and week 12
Trauma as measured by Trauma screening questionnaire (TSQ)
Time frame: 12 weeks
Anxiety as measured by generalised anxiety disorder score (GAD-7) scale
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Research and Development Manager study chair
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Post Traumatic Stress Disorder, run by Royal Free Hospital NHS Foundation Trust.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Dobbin, MScMBBS (07833457884, j.dobbin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety as measured by generalised anxiety disorder score (GAD-7) scale (time frame: Day 14). 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 28 Aug 2020.