Clinical trial NCT05000255: Coping With Covid-19: Loneliness, Self-Efficacy, Social Support, Depression & Anxiety in Patients in Medical Rehab.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Depression, Anxiety
Self Efficacy
Social Support
Covid19
Psychology
Keywords: Loneliness, Depression, Anxiety, Post-COVID, COVID-19, Psych
Lead sponsor: Helios Research Center
Sponsor class: OTHER
Collaborators: name: Jacobs University Bremen gGmbH
First posted: 2021-08-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: an experimental group comparison is performed. For the first group, a psychological intervention for psychoeducational measures and psychosocial support, was designed according to the recommendations of the DGP - Deutsche Gesellschaft für Pneumologie und Beatmungsmedizin e.V. for the rehabilitation of COVID-19 patients (DGP, 2020). The second intervention was designed after Cacioppo's intervention EASE, for processing loneliness. In this experiment, the psychological interventions will be applied to both groups of patients (non-Covid/post-Covid patients). . Patients who refuse to participate in one of the interventions but nevertheless agree to complete the questionnaires at the measurement time points are treated according to the standards of the complex treatment in early rehabilitation
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

Detailed description: Background: Increased depressive symptoms and anxiety symptoms have been observed in about 23% of all post-COVID patients, also called post-COVID depression (Huang et al., 2021). However, what a) promotes post-COVID depression after the disease and whether it is b) even post-Covid specific has not yet been conclusively understood and will be investigated in this proposed research. The theoretical basis of the proposed work is Cacioppo, Peplau, and Perlman's theory of loneliness, Bandura's self-efficacy theory, and Schwarzer's HAPA model.

Objectives: The 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, a correlational study and an experimental group comparison will be applied, in which two interventions will be performed on post-COVID patients and non-COVID patients. These two data collections will serve as the basis for a later longitudinal study, which is still in the planning stage, as follow-up questions still need to be elaborated. Methods: Around 300 patients should be included in the study. The correlation study at the first measurement point also includes a regression analysis (moderated mediation analysis). Furthermore, an experimental group comparison is performed. For the first group, a psychological intervention for psychoeducational measures and psychosocial support, was designed according to the recommendations of the DGP - Deutsche Gesellschaft für Pneumologie und Beatmungsmedizin e.V. for the rehabilitation of COVID-19 patients (DGP, 2020). The second intervention was designed after Cacioppo's intervention EASE, for processing loneliness. In this experiment, the psychological interventions will be applied to both groups of patients (non-Covid/Covid patients). The interventions start approximately two days after data collection at T0. The second measurement time point (T1) is scheduled at the time of patient discharge after the interventions have been implemented. Only patients who scored 8 or higher on the Hospital Anxiety and Depression Scale (HADS) at admission will participate in the interventions. Patients will be asked to complete the questionnaire again six months after discharge to include a third measurement point and to conduct the aforementioned longitudinal study. Patients who refuse to participate in one of the interventions but nevertheless agree to complete the questionnaires at the measurement time points are treated according to the standards of the complex treatment in early rehabilitation in which a twice psychological contact and screening by means of HADS is obligatory. They form a third group. The following instruments will be used: Items from the UCLA Loneliness Scale (Russel, 1980, German version), the Hospital Anxiety and Depression Scale (Snaith \& Zigmond, 2010), Perceived Social Support Questionnaire (F-SozU K-6, Fydrich et al., 2009); SWE - General Self-Efficacy Expectancy Scale (Schwarzer et al., 1999); various self-efficacy instruments, such as staging and Activities Against Loneliness (Lippke, 2007, adapted from Godin \& Shepard, 1985). It is expected that self-efficacy and social support play a role as mediator variables and moderator variables and that the symptomatology of depression and anxiety improves after an intervention in COVID and non-COVID patients alike. The findings of this research will contribute to a better understanding of the experience and behavior of patients with and without an infection with COVID-19 in early rehabilitation and identify opportunities for psychological intervention.

The ethics committee of Jacobs University Bremen, where Prof. Dr. Lippke supervises the PhD project, has already approved the research project. Therefore, the project is already in the recruitment phase in order to be able to use data from the third wave from the first quarter of 2021, as this is a special situation in the pandemic and the data would not be reproducible in this way.

Eligibility criteria: 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)

Primary outcomes:
measure: Measurement with the UCLA Loneliness Scale
timeFrame: approx. 14 days
measure: Measurement with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: approx. 14 days
Secondary outcomes:
measure: Measurements with the General Self-Efficacy Expectancy Scale (GSE)
timeFrame: approx. 14 days
measure: Measurements of Stage-specific Self-Efficacy, German Version, by Lippke, S.
timeFrame: approx. 14 days
measure: Measurements of Activities against loneliness, German Version, by Lippke, S.
timeFrame: approx. 14 days
measure: Measurements of Perceived Social Support, (F-SozU K-6), German Short Version, by Fydrich
timeFrame: approx. 14 days
Other outcomes:
measure: Measurement of loneliness before the COVID-19 pandemic and during the COVID-19 pandemic with prescribed measures (social constraints).
timeFrame: approx. 14 days
Locations:
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch GmbH
city: Bremen
country: Germany
facility: Jacobs University Bremen gGmbH
Study officials:
affiliation: Jacobs University Bremen gGmbH
name: Sonia Lippke, Prof. Dr.
role: STUDY_CHAIR
References: