Comparison of the Effectiveness of Online Multimedia Psycho-educational Interventions with routine Psychological Care on the Perceived Stress and Resilience of hospitalized Patients with COVID-19
The purpose of this study was to investigate the effect of online multimedia psycho-educational interventions on the perceived stress and resilience of hospitalized patients with COVID-19.
Design
Cluster randomized controlled trial with a parallel control group, double-blinded, on 50 patients. Random assignment of wards was performed by an independent observer not involved in this study, using a coin toss.
Settings and conduct
Participants in this fully online trial were consecutive patients who were hospitalized in 2 hospitals in Shiraz, after being diagnosed with COVID-19. Patients were requested to complete the baseline questionnaires within 48 h of admission to the ward. Patients allocated to the intervention group every day received videos, podcasts, texts and pictures during 2 weeks. Immediately at the end of the second week, the online instruments of the perceived stress and resilience were reapplied and the posttreatment scores were obtained.
Participants/Inclusion and exclusion criteria
Age over 18 years
Willingness to take part in the study
Diagnosis of COVID-19 by clinical manifestations and laboratory results
Having access and ability to work with the media
Hospitalization of patient due to infection with COVID-19
Intervention groups
All eligible participants in wards allocated to the intervention condition received online multimedia psychoeducational interventions during 2 weeks, whilst patients in wards allocated to the control condition received face-to-face or telephone-based psychological counseling in case of need. Psychoeducational interventions mainly included cognitive–behavioural techniques, mindfulness-based stress reduction and positive psychotherapy. We used WhatsApp as a tool to deliver multimedia psychoeducational contents (videos, podcasts, texts and pictures) to patients.
Main outcome variables
Perceived Stress; Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201001048893N1
Registration date:2020-10-03, 1399/07/12
Registration timing:retrospective
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Maryam Shaygan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 7345
Email address
m2620.shaygan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
2020-04-02, 1399/01/14
Actual recruitment end date
2020-04-30, 1399/02/11
Trial completion date
2020-05-14, 1399/02/25
Scientific title
Comparison of the Effectiveness of Online Multimedia Psycho-educational Interventions with routine Psychological Care on the Perceived Stress and Resilience of hospitalized Patients with COVID-19
Public title
Effect of Online Psycho-educational Interventions on Psychological Health of Patients with COVID-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Willingness to take part in the study
Diagnosis of COVID-19 by Clinical Manifestation and Laboratory Results
Having internet access and ability to work with the media
Hospitalization of Patient due to Infection with COVID-19
Exclusion criteria:
Previous Experience of Quarantine
Unwillingness or Inability to Continue Contributing to the Study
Having a History of Psychiatric Disorders or taking Psychiatric Medications
Death or Transfer to the ICU
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
We chose to use a cluster randomized controlled trial with hospital wards as the units of randomization (rather than individual patients). The primary reason for identifying the cluster randomized design was to protect against the ‘contamination’ that could occur in individually randomized trials. The risk of contamination was minimized by the fact that the hospitalized patients in the intervention and control hospital wards were not in contact with each other. In order to minimize imbalance across the intervention and control groups, we used a pair-matched randomization of clusters, before the start of intervention. Accordingly, to ensure comparability of the intervention and control groups, we randomly allocated one ward in each hospital to the intervention group and the other to the control group. Random assignment of wards was performed by an independent observer not involved in this study, using a coin toss.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were blinded to patient group assignment. In other words, because the patients in the experimental and control groups were hospitalized in two different wards of the hospital, they did not know how to educate the patients in the other wards of the hospital. Moreover, evaluator and analyzer of data were not informed of patient's treatment assignment. This goal was achieved by the fact that all online questionnaires had a code and the person assessing the questionnaires and analyzing the data were unaware of the grouping type of the owner of each questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features
One of the strengths of this study was the design of a new psycho-educational package based on cognitive-behavioral approaches, positive psychology and mindfulness targeting patients with Covid-19.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.SUMS.REC.1399.011
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 confirmed by laboratory testing
Primary outcomes
1
Description
Primary outcome is Resilience score on the Connor-Davidson Resilience Scale.
Timepoint
Immediately before intervention and 2 weeks later
Method of measurement
Connor-Davidson Resilience Scale
2
Description
Primary outcome is Perceived Stress score on the Perceived Stress Scale (PSS).
Timepoint
Immediately before intervention and 2 weeks later
Method of measurement
Perceived Stress Scale (PSS)
Secondary outcomes
empty
Intervention groups
1
Description
Psychoeducational interventions mainly included cognitive–behavioural techniques, mindfulness-based stress reduction and positive psychotherapy. We used WhatsApp as a tool to deliver daily multimedia psychoeducational contents (videos, podcasts, texts and pictures) to patients. Cognitive–behavioural techniques were used to teach patients how to recognize and mitigate their cognitive biases, especially in relation to disease and the likelihood of adverse events due to disease. Mindfulness techniques were incorporated to help patients recognize their negative thoughts and emotions about the disease and reduce the intensity and impact of those thoughts and emotions on their level of stress. In order to increase positive emotions and optimism in patients, positive psychotherapy exercises such as “Positive Reminiscence” and “Finding Meaning”, were taught to the patients. On average, 2 educational videos (7-8 minutes), 15 educational texts and podcasts were sent to patients for 2 weeks. Patients were daily encouraged to perform daily exercises. They shared the effectiveness or questions about how to perform the exercises with the therapy team.
Category
Treatment - Other
2
Description
Control group: Patients in wards allocated to the control condition received face-to-face or telephone-based psychological counseling in case of need.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Zahra Yazdani
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
zahrayazdani916@gmail.com
2
Recruitment center
Name of recruitment center
Ali Asghar hospital
Full name of responsible person
Zahra Yazdani
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
zahrayazdani916@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Vice Chancellor for Research, Shiraz University of Medical Sciences
Grant code / Reference number
22029
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
m2620.shaygan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3626 7345
Fax
Email
m2620.shaygan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3626 7345
Fax
Email
m2620.shaygan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Anonymous study data will be shared in correspondence with the project manager.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
A closer look at the data of patients with Covid 19
From where data/document is obtainable
Contact via email
What processes are involved for a request to access data/document
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.