Coping With Covid-19: Loneliness, Self-Efficacy, Social Support, Depression & Anxiety in Patients in Medical Rehab.

NCT05000255 | Unknown

• 1 other identifier: HeliosRC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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)

Conditions

Loneliness; Depression, Anxiety; Self Efficacy; Social Support; Covid19; Psychology

Keywords

Loneliness, Depression, Anxiety, Post-COVID, COVID-19, Psych

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Measurements with the General Self-Efficacy Expectancy Scale (GSE)

  approx. 14 days

• Measurements of Stage-specific Self-Efficacy, German Version, by Lippke, S.

  approx. 14 days

• Measurements of Activities against loneliness, German Version, by Lippke, S.

  approx. 14 days

• Measurements of Perceived Social Support, (F-SozU K-6), German Short Version, by Fydrich

  approx. 14 days

Other Outcomes (1)

• Measurement of loneliness before the COVID-19 pandemic and during the COVID-19 pandemic with prescribed measures (social constraints).

  approx. 14 days

Study Arms (3)

Intervention 1: According to DGP

EXPERIMENTAL

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 post-COVID-19 patients (DGP, 2020). 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. This psychological intervention will be applied to both groups of patients (non-Covid/Covid patients)

Behavioral: Intervention 1: According to DGP

Intervention 2: According to Cacioppo "E.A.S.E."

ACTIVE COMPARATOR

The second intervention was designed after Cacioppo's intervention EASE, for processing loneliness. This psychological intervention will be applied to both groups of patients (non-Covid/Covid patients), too. 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.

Behavioral: Intervention 2: According to Cacioppo "E.A.S.E."

Care as Usual; Standard psychological Support

NO INTERVENTION

The patients receive standard care from the psychologists, as is usual in this unit. No intervention is carried out.

Interventions

Intervention 1: According to DGP BEHAVIORAL

The first intervention is designed according to a current recommendation of the Deutsche Pneumologen Gesellschaft e.V. Its approach is resource-oriented, psychoeducational and is expected to have a positive effect on the symptomatology of depression and anxiety in the short and medium term. An additional focus was added to the intervention: planning more physical activity in daily life after discharge. The DPG intervention focuses more on the current state and aims to activate patients' resources in the short and long term. To ensure randomization of study participants, interventions will alternate weekly.

Intervention 1: According to DGP

Intervention 2: According to Cacioppo "E.A.S.E." BEHAVIORAL

The second intervention, "E. A. S. E." according to Cacioppo and Patrick (2008), addresses the social action radius of patients (here assuming that loneliness is a predictor of depression). This intervention is about planning social activities against loneliness. Cacioppo's intervention aims to encourage more social activity in the long term.

Intervention 2: According to Cacioppo "E.A.S.E."

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Annette Reichardt, MD: lead
• Jacobs University Bremen gGmbH: collaborator

Study Sites (2)

Helios Klinikum Berlin-Buch GmbH

Berlin, 13125, Germany

RECRUITING

Jacobs University Bremen gGmbH

Bremen, Germany

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sonia Lippke, Prof. Dr.

  Jacobs University Bremen gGmbH

  STUDY CHAIR

Central Study Contacts

Annika Roskoschinski, MSc

CONTACT

+49 30 9401-14837; Annika.Roskoschinski@helios-gesundheit.de

Annette Reichardt, MD

CONTACT

+49 30 9401-14852; annette.reichardt@helios-gesundheit.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Trials, Helios Research Center

Model Details: 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

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 11, 2021
• Study Start: January 18, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2025
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)