Covid19 Clinical Trial
Official title:
Coping With Covid-19: Loneliness, Self-Efficacy, Social Support and Depression and Anxiety in Patients in Medical Rehabilitation. A Field Study in Geriatrics and Physical Medicine
Aim of the study is to investigate possible predictors and factors that may be associated with the development and maintenance of mental and physical health constrains including depression and anxiety symptomatology as well as loneliness in hospitalized post-COVID patients and non-COVID patients in Germany. Furthermore, it will be investigated whether psychological interventions have an effect on anxiety and depression symptomatology, on loneliness values, self-efficacy and perceived social support values. Specifically, the research aim is to examine the relationships between loneliness, self-efficacy, and social support and to address the question of what factors increase the risk of post covid depression/anxiety, and to test the buffering effect of physical and social activities. For this purpose an experimental group comparison will be applied, in which two interventions will be performed on post-COVID patients and non-COVID patients in the unit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project by Annika Roskoschinski, M.Sc., Psychology, Principal Investigator)
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients aged 18 years to no upper limit - patients were diagnosed with COVID-19 - Non-COVID patients with the need to participate in early rehab Exclusion Criteria: - a too high language barrier or dyslexia - patients with intellectual and cognitive impairment (like primary psychiatric illness, e.g., schizophrenia or dementia, if admitted by means of medical history by a physician or if the score achieved in the cognitive screening by means of the mini-mental-state-examination (MMSE) is 23 or below 23 and no improvement of the cognitive performance is to be expected, e.g. because of an incipient dementia) |
Country | Name | City | State |
---|---|---|---|
Germany | Helios Klinikum Berlin-Buch GmbH | Berlin | |
Germany | Jacobs University Bremen gGmbH | Bremen |
Lead Sponsor | Collaborator |
---|---|
Annette Reichardt, MD | Jacobs University Bremen gGmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measurement of loneliness before the COVID-19 pandemic and during the COVID-19 pandemic with prescribed measures (social constraints). | Improving feelings of loneliness during the COVID-19 pandemic.
Scale: Feelings of loneliness before and during the pandemic, von Lippke, 2020. 2 items are used There is no cut-off value. The lower the scores for loneliness before and during the pandemic, the better. |
approx. 14 days | |
Primary | Measurement with the UCLA Loneliness Scale | Improvement in scores for loneliness: Psychological interventions are expected to improve feelings of loneliness and to decrease loneliness scores.
The following questionnaire/scale will be used for measurement at the 1st measurement time point and 2nd measurement time point 14 days later for comparison: - UCLA Loneliness Scale, German version, short form, 3 Items The lower the scores on the UCLA Loneliness Scale, the better. There is no cut-off Score. |
approx. 14 days | |
Primary | Measurement with the Hospital Anxiety and Depression Scale (HADS) | Improvement in scores for anxiety, and depression: Psychological interventions are expected to improve depression symptomatology and anxiety scores.
The following questionnaire/scale will be used for measurement at the 1st measurement time point and 2nd measurement time point 14 days later for comparison: - HADS - Hospital Anxiety and Depression Scale (HADS-D, German adaptation, 7 items Anxiety, 7 items Depression) A score of 8 or more indicates elevated levels of anxiety and depression. Scores below 8 are targeted by psychological interventions.The cut-off for anxiety and depression is 8 or more. |
approx. 14 days | |
Secondary | Measurements with the General Self-Efficacy Expectancy Scale (GSE) | Improvement in scores for self-efficacy: Psychological interventions are expected to increase self-efficacy scores.
The following questionnaire/scale will be used for measurement at the first measurement time point and 2nd measurement time point 14 days later: - General Self-Efficacy Expectancy Scale (GSE), German Version, by Schwarzer, R. The higher the values for the above scales, the better. There is no cut-off score. |
approx. 14 days | |
Secondary | Measurements of Stage-specific Self-Efficacy, German Version, by Lippke, S. | Improvement of Stage-specific Self-Efficacy:
Psychological interventions are expected to improve Stage-specific Self-Efficacy. The following questionnaire/scale will be used for measurement at the 1st measurement time point and 2nd measurement time point 14 days later: - Stage-specific Self-Efficacy, by Lippke, 1 Item, German Version There is no cut-off value. |
approx. 14 days | |
Secondary | Measurements of Activities against loneliness, German Version, by Lippke, S. | Improvement of Activities against loneliness:
Psychological interventions are expected to improve or motivate activities against loneliness. The following questionnaire/scale will be used for measurement at the 1st measurement time point and 2nd measurement time point 14 days later: - Activities against loneliness, by Lippke, 13 Items, German Version The higher the value for the above scale, the better. There is no cut-off value. |
approx. 14 days | |
Secondary | Measurements of Perceived Social Support, (F-SozU K-6), German Short Version, by Fydrich | Improvement in scores for social support:
Psychological interventions are expected to increase scores of subjectively perceived social support. The following questionnaire/scale will be used for measurement at the 1st measurement time point and 2nd measurement time point 14 days later: - Perceived Social Support Questionnaire (F-SozU K-6), German Version, by Fydrich (6 Items) The higher the values for the above scales, the better. there is no cut-off value. |
approx. 14 days |
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