An interventional study of Psychological and Physiological Assessments in Long-COVID, Post-COVID and Psychosomatic Disorder, sponsored by Prof. Dr. Sonia Lippke. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Prof. Dr. Sonia Lippke · Not applicable, Interventional, and Health services research
Post-/long-COVID occurs in patients with severe, moderate, and even mild courses. The symptomatology is multi-layered and complex. Patients with mild and moderate courses and especially younger patients are not optimally integrated into one of the existing care structures of COVID outpatient clinics and regular primary care. The diagnosis of post-/long-COVID and a consequent targeted treatment are currently partly not ensured. The variability of symptoms and the resulting complexity of diagnosis and treatment also pose a challenge in rural areas.
The aim of the project is an evaluation of a program for low-threshold needs identification and treatment planning for a hybrid (personal supporting counselors and digital trainings) post-/long-COVID care.
The contents of the present project include an innovative basis outside the existing standard care for the identification of affected persons. This will be done by means of a low-threshold online screening, which can also be carried out by the affected persons themselves. Furthermore, an intensive interdisciplinary assessment linked to medical rehabilitation resulting in a comprehensive, interdisciplinary, and cross-sectoral treatment plan is a core component of the current project. Finally, the implementation of digital trainings which are accompanied by a personal supporting counselor and augmented by continuously available trainings in the form of digital modules aim to provide general recommendation for the future support of post/long-COVID care.
The current research project aims to evaluate the feasibility and the practicability of a comprehensive, interdisciplinary, and cross-sectoral treatment program consisting of a low-threshold online screening and holistic assessment for PACS. Furthermore, it aims to evaluate digital interventions and the use of so-called personal guides that may help to facilitate the recovery of PACS.
The goal is the long-term and sustainable holistic treatment and support of patients with post-/long-COVID to prevent long-term illness and chronification. Following the earliest possible, low-threshold identification of post-/long-COVID sufferers, an intensive multidisciplinary assessment is conducted, resulting in holistic treatment planning based on the results of the assessment. This consists of recommendations for a coordinated, interdisciplinary therapy plan. At the same time, digital therapy offers are recommended and made available to patients. Patients are accompanied by a supporting counselor (personal pilot) who guides them through the entire care process. This closes the gap between acute care of COVID-19 and outpatient therapy or rehabilitation of post-/long-COVID.
To identify patients with post-/long-COVID symptoms, a low-threshold scientifically based online-screening that confirms the presence of post-/long-COVID syndrome and an three day inpatient assessment that determines the need for further treatment will be developed, validated and prepared for standard care. Long-term goals are the dissemination of the validated instruments to diagnose post-long-COVID and treatment approaches (interdisciplinary, individualized treatment plan) through communication to key stakeholders such as medical associations, health insurance companies, service providers in the outpatient and inpatient sector, as well as professional societies and care institutions. This is intended to improve patient care and make care delivery of treatments for post-/long-COVID patients more efficient beyond the project duration.
Standard care currently diagnoses post-/long-COVID and provides recommendations for treatment through primary care practices and specialized post-COVID outpatient clinics. Both access routes inadequately reach those affected especially in rural areas. Long-/post-COVID outpatient clinics are primarily located in metropolitan areas and are therefore mainly available to the population in large cities. In particular, young affected individuals who have had little to no prior outpatient care due to a very mild course do not have primary care and often do not have the knowledge of the specific post-/long-COVID symptomatology and potentially seek insufficient and delayed medical support. This may result in aggravation and possibly chronification of symptoms and consequent long-term disability/ incapacity with limited participation. This in turn can have a negative impact on the continuation or resumption of work and lead to economic burdens for the whole society.
The contents of the present project include, as an innovative basis outside the existing standard care, the low-threshold identification of affected persons, an intensive interdisciplinary assessment resulting in a comprehensive, interdisciplinary and cross-sectoral treatment plan, the implementation of which is controlled and accompanied by a personal supporting counselor and augmented by continuously available training in the form of digital offers.
The following research questions and hypotheses will be investigated with this project and subsequently communicated to the various stakeholders and the general public:
The project aims to optimize care for post-/long-COVID patients and empower them to participate socially. Affected individuals are supported on their way to the appropriate therapeutic and rehabilitative care by expert staff, the supporting counselors (personal pilots), and receive interdisciplinary multi-professional treatment focused on individual complaints. Affected individuals are accompanied and supported through digital interventions. The low-threshold access via an online-screening leads to the elimination of information loss and inhibitions. Various digital services, such as DiGAs, video consultations, as well as aftercare services are increasingly used. This is of particular benefit to patients who have tight schedules and/or live in rural regions with a low density of doctors/therapists.
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's enrollment of 192 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →This is the only study on the registry with Prof. Dr. Sonia Lippke as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention) Patients from Bavaria Germany: Contact to personal pilots and digital health interventions.
Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention) Patients from Bavaria Germany: Assessment in clinics for post-/long-COVID, contact to personal pilots and digital health interventions.
Diagnostic Test: Psychological and Physiological Assessments
Questionnaires at timepoints t1 (screening), t2 (comparable to t2 in the other groups), t3 (comparable with t4 in the other groups), t3 (comparable to t5 in the other groups) Patients from Germany: No intervention at all
About N = 60 patients admitted to the study receive a 3-day assessment (a further examination) at the Kiliani-Klinik Bad Windsheim which considers physical and psychological parameters relevant for the diagnosis of a Post-/ Long-COVID Syndrom.
Change from baseline in the Post-/ Long-COVID symptoms at 3 months
The symptom change with regard to Post-/Long-COVID will be evaluated by at least three follow-up measures, using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Health Problems caused by SARS-CoV-2 (Lemhöfer, C., et al. (2021)), with 14 items. Possible scores range from 1 (no problem) to 5 (extreme problem). Change = (Score at measurement points (e.g.,3 months) - Score at baseline)
Time frame: Baseline to 3 months
Subjective prognosis of return to work
Return to work will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The questionnaire is adapted to the context of COVID-19 from the SPE scale (Mittag, O., \& Raspe, H. (2003)), with 4 items.
Time frame: 2 weeks, 8 weeks
Activity and social participation
Social participation will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Activity and participation (Lemhöfer, C., et al. (2021)), with 12 items. Possible scores range from 1 (Never) to 5 (Often/always).
Time frame: 2 weeks, 8 weeks
Health behaviors of daily living
Health behaviors of daily living including physical activity and nutrition consumption behavior, and sedentary behavior will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The physical activity and nutrition consumption questionnaire is adapted from the Physical Activity and Fruit and Vegetable Consumption Questionnaire (Lippke, S., et al. (2009)), with 2 items. The sedentary behavior questionnaire is adapted from the International Physical Activity Questionnaire (Craig, C. L.,et al. (2003)), with 2 Items.
Time frame: 2 weeks, 8 weeks
Mental health
Mental health including loneliness, psychological distress, stress, depression and anxiety will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The loneliness questionnaire is adapted from the UCLA loneliness scale (Russell, D. (1996)), with 2 items. The psychological distress will be assessed by Peri-traumatic Distress Scale (Qiu, J. et al. (2020)), with 24 items. The stress questionnaire is adapted from the PSS-4 (Cohen, S. (1988)), with 4 items. The depression and anxiety questionnaire is adapted from the PHQ-4 (Löwe, B.,et al. (2010)), with 4 items.
Time frame: 2 weeks, 8 weeks
Life satisfaction
Life satisfaction will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the General Satisfaction with Life Questionnaire (Beierlein, C., et al. (2015)), with 4 items. Possible scores range from 1 (totally unsatisfied) to 4 (very satisfied).
Time frame: 2 weeks, 8 weeks
Plan to share: No — Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.
Ran from Dec 2021 to primary completion in Dec 2022, 12 months.
Of 233 non-industry interventional studies with no phase under Post-Acute COVID-19 Syndrome, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's 12 months is below that.
Counting every sponsor, half of 244 studies reached it within 16 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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