Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05000255
Status:
RECRUITING
Last Update Posted:
2021-08-11
First Post:
2021-07-25
Brief Title:
Coping With Covid-19 Loneliness Self-Efficacy Social Support Depression Anxiety in Patients in Medical Rehab
Sponsor:
Annette Reichardt MD
Organization:
Helios Research Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 depressionanxiety 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 MSc 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 Perlmans theory of loneliness Banduras self-efficacy theory and Schwarzers 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 depressionanxiety 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 eV for the rehabilitation of COVID-19 patients DGP 2020 The second intervention was designed after Cacioppos intervention EASE for processing loneliness In this experiment the psychological interventions will be applied to both groups of patients non-CovidCovid 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
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 depressionanxiety 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 eV for the rehabilitation of COVID-19 patients DGP 2020 The second intervention was designed after Cacioppos intervention EASE for processing loneliness In this experiment the psychological interventions will be applied to both groups of patients non-CovidCovid 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None