Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention (FeelGood)
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|ClinicalTrials.gov Identifier: NCT04449627|
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : August 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Anxiety Disorders Post Traumatic Stress Disorder Depressive Disorder Covid19||Other: Feeling Good Digital App|
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Official Title:||Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention|
|Estimated Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
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
Audio based tracks using Jacobson relaxation and mindfullness based cognitive therapy (MBCT) techniques including positive visualisation.
- 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.
- Depression as measured by the patient health questionnaire 9 (PHQ-9) [ Time Frame: 14 days and week 12 ]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.
- Trauma as measured by Trauma screening questionnaire (TSQ) [ Time Frame: 12 weeks ]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.
- Anxiety as measured by generalised anxiety disorder score (GAD-7) scale [ Time Frame: Week 12 ]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.
- Risk associated with distress [ Time Frame: Baseline analysis ]Risk 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 analysis [ Time Frame: Baseline ]Framework 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449627
|Contact: Joanna Dobbin, MScMBBSemail@example.com|
|Study Chair:||Research and Development Manager||Sponsor GmbH|