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IRCT20201001048893N1 IRCT 2020-10-03 Shiraz University of Medical Sciences Effect of Online Psycho-educational Interventions on Psychological Health of Patients with COVID-19 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 2020-03-10 anticipated 50 Complete https://irct.ir/trial/51328 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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 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. N/A COVID-19. Intervention 1: 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. Intervention 2: Control group: Patients in wards allocated to the control condition received face-to-face or telephone-based psychological counseling in case of need. Yes - There is a plan to make this available What will be shared: Anonymous study data will be shared in correspondence with the project manager. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: A closer look at the data of patients with Covid 19 Where to obtain: Contact via email How to obtain: After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual. Comments:
public Maryam Shaygan
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3647 4254 m2620.shaygan@gmail.com Shiraz University of Medical Sciences scientific Maryam Shaygan
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3626 7345 m2620.shaygan@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19 confirmed by laboratory testing Treatment - Other Treatment - Other 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. Control group: Patients in wards allocated to the control condition received face-to-face or telephone-based psychological counseling in case of need. 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. 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). Shiraz University of Medical Sciences Approved 2020-03-18 Ethics committee of Shiraz University of Medical Sciences School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)