LonelinessNCT05000255
Coping With Covid-19: Loneliness, Self-Efficacy, Social Support, Depression & Anxiety in Patients in Medical Rehab.
A study testing Intervention 1: According to DGP and Intervention 2: According to Cacioppo "E.A.S.E." in people with Loneliness and Depression, Anxiety, run by Annette Reichardt, MD at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Depression, Anxiety, Self Efficacy
- What is being tested?
- Intervention 1: According to DGP and Intervention 2: According to Cacioppo "E.A.S.E."
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Jan 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Helios Klinikum Berlin-Buch GmbH
Berlin, 13125
Annette Reichardt, MD, +49 30 9401-14852, annette.reichardt@helios-gesundheit.de
Annika Roskoschinski, MSc.
- Recruiting
Jacobs University Bremen gGmbH
Bremen
Sonia Lippke, Prof. Dr., s.lippke@jacobs-university.de
Sonia Lippke, Prof. Dr.
About this study
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)
Read the 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.
- Conditions
- Loneliness, Depression, Anxiety, Self Efficacy, Social Support, Covid19, Psychology
- Being tested
- Intervention 1: According to DGP, Intervention 2: According to Cacioppo "E.A.S.E."
- Keywords
- Loneliness, Depression, Anxiety, Post-COVID, COVID-19, Psych
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: According to DGPBehavioural
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 2: According to Cacioppo "E.A.S.E."Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: approx. 14 days
Secondary outcomes (4)
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.
Measured: approx. 14 days
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.
Measured: approx. 14 days
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.
Measured: approx. 14 days
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.
Measured: approx. 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start18 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annette Reichardt, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Jacobs University Bremen gGmbH
- Responsible party
- Sponsor-investigator, Annette Reichardt, MD, Helios Research Center
- Investigators
- Sonia Lippke, Prof. Dr., Study chair, Jacobs University Bremen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000255
- Sponsor's protocol ID
- HeliosRC
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05000255
- Acronym / sponsor ID
- HeliosRC
- Conditions
- Loneliness, Depression, Anxiety, Self Efficacy, Social Support, Covid19, Psychology
- Keywords
- Loneliness, Depression, Anxiety, Post-COVID, COVID-19, Psych
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Annette Reichardt, MDUniversity, hospital or other
- Collaborators
- Jacobs University Bremen gGmbH
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention 1: According to DGP | Experimental | Behavioral: Intervention 1: According to DGPFor 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) |
| Intervention 2: According to Cacioppo "E.A.S.E." | Active comparator | Behavioral: Intervention 2: According to Cacioppo "E.A.S.E."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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: According to DGPThe 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. | Behavioural | Intervention 1: According to DGP |
| Intervention 2: According to Cacioppo "E.A.S.E."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. | Behavioural | Intervention 2: According to Cacioppo "E.A.S.E." |
Primary outcome
Measurement with the UCLA Loneliness Scale
Time frame: approx. 14 days
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.
Measurement with the Hospital Anxiety and Depression Scale (HADS)
Time frame: approx. 14 days
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.
4 secondary outcomes
Measurements with the General Self-Efficacy Expectancy Scale (GSE)
Time frame: approx. 14 days
Measurements of Stage-specific Self-Efficacy, German Version, by Lippke, S.
Time frame: approx. 14 days
Measurements of Activities against loneliness, German Version, by Lippke, S.
Time frame: approx. 14 days
Measurements of Perceived Social Support, (F-SozU K-6), German Short Version, by Fydrich
Time frame: approx. 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Lippke, Prof. Dr. study chair
Jacobs University Bremen gGmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: According to DGP and Intervention 2: According to Cacioppo "E.A.S.E." in people with Loneliness and Depression, Anxiety, run by Annette Reichardt, MD at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika Roskoschinski, MSc (+49 30 9401-14837, Annika.Roskoschinski@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement with the UCLA Loneliness Scale (time frame: approx. 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.