Plain English Summary
Background and study aims
As a public health emergency of international concern, the COVID-19 outbreak has resulted in a significant burden on health systems as well as economic development, along with a significant impact on individual’s physical and psychological health. The number of infected and confirmed cases increased rapidly in a short period due to a lack of knowledge of this new infectious disease, of which more 80% were patients with mild symptoms. The existing research also highlights that patients with COVID-19 suffer high levels of anxiety, depression, loneliness, despair and anger, which can further develop into severe mental disorders such as acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). A small number of patients demonstrate extreme psychological behaviours during the COVID-19 pandemic, such as blaming, abusing medical staff and tearing up protective equipment, which exposed front-line medical staff to a higher risk. In addition, multiple studies have documented that without timely psychological intervention and assistance, psychological symptoms such as anxiety and depression can further develop into severe mental disorders such as acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). Therefore, effective psychological intervention at the early stages of COVID-19 is important for patients.
Cognitive behavioural therapy (CBT) as evidence-based psychotherapy has been widely used in the treatment and prevention of physical and psychological distress in both the community and inpatients. It aims to help individuals to identify stress levels and modify negative cognitive beliefs and behaviours, reduce or eliminate symptoms of psychological distress, and further help individuals back to their normal life in terms of psychological and social functions.
The aim of this study is to apply CBT to patients with COVID-19, and examine the effectiveness of CBT in relieving patients' psychological distress during the COVID-19 pandemic.
Who can participate?
Patients aged 20-69 with COVID-19 who had mild symptoms in line with the diagnostic criteria of the Chinese Management Guidelines for COVID-19 (version 6.0)
What does the study involve?
Participants will be randomly assigned to either the intervention group and the control group. The control group receive routine treatment according to the Chinese Management Guidelines for COVID-19 (including antiviral treatment, symptomatic treatment of fever and nursing care), while participants in the intervention group receive routine treatment with additional CBT. Participants will be asked to complete an assessment before and after the intervention to assess the effectiveness of the CBT intervention in terms of reducing depression, anxiety and stress levels.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the CBT intervention may help to reduce patients’ depression, anxiety and stress, and to improve their psychological health. There are no known risks to participants taking part in this study.
Where is the study run from?
The First Affiliated Hospital of Bengbu Medical College (China)
When is the study starting and how long is it expected to run for?
February 2020 to March 2020
Who is funding the study?
Bengbu Medical College (China)
Who is the main contact?
Prof. Jin Zhi Li
2639917769@qq.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jinzhi Li
ORCID ID
http://orcid.org/0000-0002-4372-2340
Contact details
No 2600
Donghai Avenue
Bengbu
233030
China
+86 (0)552 3175212
2639917769@qq.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
The effect of cognitive behavioural therapy on depression, anxiety and stress in patients with COVID-19: a randomized controlled trial
Acronym
Study hypothesis
The COVID-19 outbreak has had a tremendous impact on patients’ psychological health. They suffer high levels of anxiety, depression, loneliness, despair and anger. Cognitive Behavioural Therapy (CBT) can reduce patients' depression, anxiety and stress.
Ethics approval
Approved 04/02/2020, Ethics Committee of the First Affiliated Hospital of Bengbu Medical College (No.287, Changhuai Road, Bengbu City, Anhui Prov, China, 233000; +86 (0)552 3086046; no email address), ref: BYYFY-2020KY10
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Depression, anxiety and stress in patients with COVID-19 (SARS-CoV-2 infection)
Intervention
Ninety-three eligible participants selected by cluster sampling are randomized to an intervention group (n = 47) and a control group (n = 46) using a computerized random number generator by a trial statistician who had no clinical involvement in the project.
Participants in the control group receive routine treatment according to the Chinese Management Guidelines for COVID-19, while participants in the intervention group receive routine treatment with additional CBT.
The cognitive intervention includes:
1. Providing information related to COVID-19, real-time information on the COVID-19 outbreak
2. Giving clear and comprehensive explanations to patients' questions
The behaviour intervention includes:
1. Instruction on self-protection behaviours such as proper hand-washing technique
2. Self-monitoring COVID-19 related symptoms
3. Relaxation techniques such as music therapy and breath meditation
4. Encourage patients to maintain close communication with family and friends through a mobile phone or WeChat (a communication app)
The CBT intervention is performed once a day in the morning, taking 30 minutes to complete and is recorded by the nurses. Each intervention is strictly carried out through face-to-face communication, with a patient-centred approach so the intervention could be adjusted based on the individual’s needs.
The duration of intervention ranged from 7 to 29 days.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Psychological health level of the patient with COVID-19, assessed using the Chinese Version of
Depression Anxiety and Stress Scale-21 (DASS-21) for all participants at baseline and post-
intervention (1 day later)
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/02/2020
Overall trial end date
22/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with COVID-19 who had mild symptoms in line with the diagnostic criteria of the Chinese Management Guidelines for COVID-19 (version 6.0)
2. Good communication and understanding of Chinese
3. Aged 20-69 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
93 participants (47 in the intervention group; 46 in the control group)
Total final enrolment
93
Participant exclusion criteria
1. Previously diagnosed with depression and currently taking medication
2. Prior cognitive dysfunction
3. Experienced another major stressful event (e.g. divorce, bereavement) in the past year
Recruitment start date
10/02/2020
Recruitment end date
22/03/2020
Locations
Countries of recruitment
China
Trial participating centre
The First Affiliated Hospital of Bengbu Medical College
Department of Infectious Diseases
No. 287, Changhuai Road
Bengbu City
Anhui Prov
Bengbu
233000
China
Sponsor information
Organisation
Bengbu Medical College
Sponsor details
No 2600
Donghai Avenue
Bengbu
233030
China
+86 (0)552 3175066
bykyc2012@163.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Bengbu Medical College
Alternative name(s)
BBMC
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
China
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as it is stipulated in the informed consent signed with the patient that any information of the participants will not be disclosed, and the dataset compiled for this study will be kept and stored by the first author.
Intention to publish date
01/09/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list