Psychosomatic DisorderAnhandCOV19NCT04453475
Feasibility and Benefits of Digital Services During the COVID19 Pandemic
A study testing Training session adressing information and health literacy in people with Psychosomatic Disorder and Psychological Distress, run by Jacobs University Bremen gGmbH at 1 site in Germany.
Trial summary
As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosomatic Disorder, Psychological Distress, Psychological Stress
- What is being tested?
- Training session adressing information and health literacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients before the start of the treatment
- Selected by the clinic
- Invited to participate in the study
Who cannot join
- Inability to read and write
- Severe dementia
- unwillingness to participate in the study and to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)
As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time.
How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?
Read the detailed description
In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and rehabilitation care. This crisis is not a short-term event but will also has longer-term effects on health care service/rehabilitation. Necessary adjustments due to hygiene and distance regulations include, for example, the reduction of group sizes and alternatives to conventional service provision (= digital services, McNeary et al., 2020). How such offers are perceived and accepted by patients and staff is crucial for the effect on the care. Systematic research into the pandemic from the patient and employee perspective, its consequences for procedures in rehabilitation clinics and for the implementation of the necessary therapies is required in a timely manner in order to better understand and mitigate the effects of the pandemic and to ensure the effectiveness of rehabilitation. This is the aim of this project with a focus on digital services and their subjective usefulness.
Furthermore, the integration of such offers can mean that a therapist is not present during the entire therapy, but that rehabilitants first learn the basics of a topic in self-study. This is based on the principle of the "Flipped Classroom". (Rehab) Patients as well as employees of the clinics are involved in the piloting of the survey instruments and the final choice of outcome criteria as well as the derivation of possible applications (guidelines, recommendations for rehabilitants).
In addition, the pandemic is negatively associated with equal participation of vulnerable groups (e.g. persons with physical or psychological handicaps). In the case of medical rehabilitation patients, particular occupational problems make equal participation and social cohesion more difficult: problems such as long-term limited productivity or the threat of exclusion from the labor market (pension for reduced earning capacity), negative employment forecasts and experiences of previously limited social participation are in turn further exacerbated by demographic change and the consequences of the COVID 19 pandemic. These restrictions are also reflected in the increased experience of loneliness. To date, however, there is a lack of a systematic understanding of these circular, dynamic processes and low-threshold, effective approaches to action, effective approaches to action.
The following questions will be empirically investigated:
- How are digital services evaluated regarding feasibility, acceptance and subjective usefulness in light of the current situation?
- Which characteristics of rehabilitants are related to the acceptance and subjective usefulness of digital offers?
- For which patients of rehabilitation is there a need for support in the use of digital services to achieve rehabilitation goals?
- Are there differences in perceived usefulness between services?
- How do people in the welfare state and labor market with disabilities and impairments (rehabilitants) perceive the consequences of the Covid 19 pandemic and the transformation processes?
- How effective are support measures with regard to communication for rehabilitants in supporting equal participation?
- How should support for equal participation be designed in the long term: What What are the consequences for labor market and social policy?
The methodology uses a natural variation design within the Dr. Becker Clinical Group in order to investigate the issues at the highest possible scientific level and to achieve reliable results. The interventions consist of an online depression session as a "flipped classroom" and/or an online lecture with socio-medical content, and/ or a tobacco cessation lecture, which are combined in such a way that the differential effects can be evaluated. For this purpose, a control group is included that does not participate in these interventions (but receives the standard rehabilitation treatment programm). Furthermore, all groups voluntarily receive patient training before rehabilitation with the content of setting "treatment goals" as well as an invitation to pre- and post-surveys.
The survey methods are online surveys (before the treatment=pre (T1); end of treatment=post (T2); end of treatment=post 12 weeks (T3)) by means of UniPark.
The main target variables are reported behavior and well-being (stress/burden of COVID-19 disease or probability of disease, limitations, quality of life, anxiety or depression; pre-post comparison) as well as subjective need (pre) and benefit (post) of the digital services. Further primary target variables are concentrated on social participation, workability and return to work. The theoretical foundation for the selection of target variables and constructs is the Carry-Over Action Model. The sample includes all rehabilitands who undergo a psychosomatic rehabilitation in the hospitals. The planned sample size of the rehabilitants is N = 2,000.
The feasibility is given by the use of an existing care system with cover letters from the patients before the treatment. Possible disturbance variables such as affinity towards technology (which could lead to a lower participation rate among participants with little affinity towards technology) are controlled for and taken into account in the evaluation. Gender and diversity are considered as covariates or moderators in the statistical models.
All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant.
The results of this study will show which digital implementation forms of therapy offers are feasible in terms of benefit and acceptance and can thus contribute to the further development of health care services and medical rehabilitation. This will create the necessary evidence base to include digital offers in the classification of therapeutic services and the therapy standards based on them and thus to establish them in routine care. Furthermore, a guideline for the future integration of these services into the health care services/rehabilitation process will be developed. Due to the standardized combination of analogue and digital therapy parts, therapy goals can be achieved more efficiently on the basis of the validated pedagogical concepts used and with the involvement of fewer human resources. This is not only relevant during the SARS-CoV-2 pandemic, but also with regard to the relevant shortage of qualified personnel. Furthermore, the research basis for digital measures to support social support for social participation will be created. With these findings, similar measures on other groups, for example, persons with disabilities or limitations, can be researched.
- Conditions
- Psychosomatic Disorder, Psychological Distress, Psychological Stress, Psychological Disease, Psychological Disorder, Psychological Impairment
- Being tested
- Training session adressing information and health literacy
- Keywords
- health behavior change, stress, eHealth, digital intervention, medical rehabilitation, clinic stay
- Medical subject headings
- Psychophysiologic Disorders, Stress, Psychological, Mental Disorders, Communication, Patient Acceptance of Health Care, Anxiety Disorders, Health Behavior, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training session adressing information and health literacyBehavioural
The training sessions are provided online and as alternative to face-to-face treatments which cannot be provided as before due to the safety regulations relating to Covid-19
| Study group | Role | What they receive |
|---|---|---|
| Partial digital group: depression | Experimental | Burg
Online depression session as a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals Receives: Behavioral: Training session adressing information and health literacy |
| Partial digital group: social work (social medicine) | Experimental | NOR
Online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals Receives: Behavioral: Training session adressing information and health literacy |
| Partial digital group: depression + social work | Experimental | JUL
Online depression session as a "flipped classroom" and an online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals Receives: Behavioral: Training session adressing information and health literacy |
| Control group: only digital training before rehabilitation | Active comparator | MOE
Online tobacco cessation a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals Receives: Behavioral: Training session adressing information and health literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)
Quantitative online questionnaire Survey using UniPark
Measured: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Usability and effectiveness of digital interventions
Quantitative online questionnaire Survey using UniPark
Measured: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Stressors and barriers due to Covid-19
Quantitative online questionnaire Survey using UniPark
Measured: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Psychosomatic DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of an online depression session as a "flipped classroom" and/or an online lecture with socio-medical content, which are combined in such a way that the differential effects can be evaluated. For this purpose, a control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Becker Hospital Group, Dr. Becker Burg-Klinik (Burg), Dr. Becker Klinik Norddeich (NOR), Dr. Becker Klinik Juliana (JUL), Dr. Becker Klinik Möhnesee
- Responsible party
- Sponsor
- Investigators
- Sonia Lippke, Prof. Dr., Principal investigator, Jacobs University Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453475
- Sponsor's protocol ID
- Anhand-COVID19
- Acronym
- AnhandCOV19
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2020
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Baumeister, H., Reichler, L., Munzinger, M., & Lin, J. (2014). The impact of guidance on Internet-based mental health interventions - A systematic review. Internet Interventions, 1(4), 205-215. <br /> Direito, A., Carraça, E., Rawstorn, J., Whittaker, R., & Maddison, R. (2017). mHealth technologies to influence physical activity and sedentary behaviors: behavior change zechniques, systematic review and meta-analysis of randomized controlled trials. Annals of Behavioral Medicine, 51, 226-239. doi: 10.1007/s12160-016-9846-0 <br /> Elbert, N. J., Van Os-Medendorp, H., van Renselaar, W., Ekeland, A. G., Hakkaart-van Roijen, L., Raat, H., … Gma, S. (2014). Effectiveness and cost-effectiveness of eHealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. Journal of Medical Internet Research, 16, e110. doi: 10.2196/jmir.2790 <br /> Fleig, L., Lippke, S., Pomp, S., & Schwarzer, R. (2011). Intervention effects of exercise self-regulation on physical exercise and eating fruits and vegetables: a longitudinal study in orthopedic and cardiac rehabilitation. Preventive Medicine, 53, 182-187. <br /> Fleig, L., Pomp, S., Schwarzer, R., & Lippke, S. (2013). Promoting exercise maintenance: How interventions with booster sessions improve long-term rehabilitation outcomes. Rehabilitation Psychology, 58, 323-333. <br /> Granja, C., Janssen, W., & Johansen, M. A. (2018). Factors determining the success and failure of eHealth interventions: systematic review of the literature. Journal of Medical Internet Research, 20, e10235. doi: 10.2196/10235 <br /> Hong, Z., Li, N., Li, D., Li, J., Li, B., Xiong, W., Lu, L., Li, W., & Zhou, D. (2020). Telemedicine during the COVID-19 pandemic: experiences from Western China. Journal of Medical Internet Research, 22, e19577. <br /> Lippke, S., Preißner, C., & Whittal, A. (2018). Facilitating health literacy and behavior change by computer-tailored interventions. In: A. K. Mayer (Ed.). Health Literacy Across the Life (pp. 39-58). Lengerich: Pabst Science Publishers. <br /> Lustria, M. L. A., Noar, S. M., Cortese, J., Van Stee, S. K., Glueckauf, R. L., & Lee, J. (2013). A meta-analysis of web-delivered tailored health behavior change interventions. Journal of Health Communication: International Perspectives, 18, 1039-1069. doi: 10.1080/10810730.2013.768727 <br /> McNeary, L., Maltser, S., Verduzco-Gutierrez, M. (2020). Navigating coronavirus disease 2019 (Covid-19) in physiatry: a CAN report for inpatient rehabilitation facilities. PM R, 12, 512-515. doi:10.1002/pmrj.12369 <br /> Milne-Ives, M., Lam, C., De Cock, C., Van Velthoven, M. H., & Meinert, E. (2020). Mobile apps for health behaviour change in physical activity, diet, drug and alcohol use, and mental health: a systematic review. JMIR Mhealth Uhealth, 8, e17046. doi: 10.2196/17046 <br /> Padala, P. R., Jendro, A. M., & Padala, K. P. (2020). Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveillance, 6, e18887. <br /> Pérez Sust, P., Solans, O., Fajardo, J.C., Medina Peralta, M., Rodenas, P., Gabaldà, J., Garcia Eroles, L., …, Piera-Jimenez, J. (2020). Turning the crisis into an opportunity: Digital health strategies deployed during the COVID-19 outbreak. JMIR Public Health Surveillance, 6, e19106. <br /> Schuler, M., Murauer, K., Stangl, S., Grau, A., Gabriel, K., Podger, L., . . . Faller, H. (2019). Pre-post changes in main outcomes of medical rehabilitation in Germany: Protocol of a systematic review and meta-analysis of individual participant and aggregated data. BMJ Open, 9. doi:10.1136/bmjopen-2018-023826 <br /> Sheehy, L. M. (2020). Considerations for postacute rehabilitation for survivors of COVID-19. JMIR Public Health Surveillance, 6, e19462. <br /> Storm, V., Dörenkämper, J., Reinwand, D., Wienert, J., De Vries, H., & Lippke, S. (2016). Effectiveness of a web-based computer-tailored multiple-lifestyle intervention for people interested in reducing their cardiovascular risk: A randomized controlled trial. Journal of Medical Internet Research, 18, e78. <br /> Vugts, M. A. P., Joosen, M. C. W., van der Geer, J. E., Zedlitz, A. M. E. E., & Vrijhoef, H. J. M. (2018). The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS ONE, 13, e0196467. https://doi.org/10.1371/journal.pone.0196467 <br /> Weisel, K. K., Fuhrmann, L. M., Berking, M., Baumeister, H., Cuijpers, P., & Ebert, D. D. (2019). Standalone smartphone apps for mental health - a systematic review and meta-analysis. npj Digital Medicine, 2, 1-10.
Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Psychosomatic Rehabilitation Patients and the General Population During COVID-19: Online Cross-sectional and Longitudinal Study of Digital Trainings and Rehabilitation Effects. JMIR Ment Health. 2021 Aug 26;8(8):e30610. doi: 10.2196/30610.
PubMed 34270444Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Implementing Digital Trainings within Medical Rehabilitations: Improvement of Mental Health and Synergetic Outcomes with Healthcare Service. Int J Environ Res Public Health. 2021 Aug 25;18(17):8936. doi: 10.3390/ijerph18178936.
PubMed 34501524Dahmen A, Keller F, Kotting L, Derksen C, Lippke S. [Fear of Coronavirus, Intention to Follow the AHA Rules and Risk Perception Regarding Visits to the Doctor: Cross-sectional Study with Patients suffering from Pre-existing Mental Illness]. Gesundheitswesen. 2021 Apr;83(4):274-281. doi: 10.1055/a-1397-7214. Epub 2021 Apr 8. German.
PubMed 33831971Dahmen A, Keller FM, Derksen C, Kotting L, Lippke S. [Which Digital Services do Psychosomatic Rehabilitation Patients Use During the Corona Pandemic and do Interrelations with Anxiety and Depressive Symptoms Exist?]. Psychother Psychosom Med Psychol. 2021 Dec;71(12):508-514. doi: 10.1055/a-1503-5548. Epub 2021 Sep 20. German.
PubMed 34544173Keller FM, Derksen C, Kotting L, Dahmen A, Lippke S. Distress, loneliness, and mental health during the COVID-19 pandemic: Test of the extension of the Evolutionary Theory of Loneliness. Appl Psychol Health Well Being. 2023 Feb;15(1):24-48. doi: 10.1111/aphw.12352. Epub 2022 Mar 9.
PubMed 35266309
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)
- ClinicalTrials.gov ID
- NCT04453475
- Acronym / sponsor ID
- AnhandCOV19 / Anhand-COVID19
- Conditions
- Psychosomatic Disorder, Psychological Distress, Psychological Stress, Psychological Disease, Psychological Disorder, Psychological Impairment
- Keywords
- health behavior change, stress, eHealth, digital intervention, medical rehabilitation, clinic stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Collaborators
- Dr. Becker Hospital Group, Dr. Becker Burg-Klinik (Burg), Dr. Becker Klinik Norddeich (NOR), Dr. Becker Klinik Juliana (JUL), Dr. Becker Klinik Möhnesee
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Jul 2020 (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.
As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time.
How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?
Detailed description
In Germany, the SARS-CoV-2 pandemic represents a crisis with massive effects on health and rehabilitation care. This crisis is not a short-term event but will also has longer-term effects on health care service/rehabilitation. Necessary adjustments due to hygiene and distance regulations include, for example, the reduction of group sizes and alternatives to conventional service provision (= digital services, McNeary et al., 2020). How such offers are perceived and accepted by patients and staff is crucial for the effect on the care. Systematic research into the pandemic from the patient and employee perspective, its consequences for procedures in rehabilitation clinics and for the implementation of the necessary therapies is required in a timely manner in order to better understand and mitigate the effects of the pandemic and to ensure the effectiveness of rehabilitation. This is the aim of this project with a focus on digital services and their subjective usefulness.
Furthermore, the integration of such offers can mean that a therapist is not present during the entire therapy, but that rehabilitants first learn the basics of a topic in self-study. This is based on the principle of the "Flipped Classroom". (Rehab) Patients as well as employees of the clinics are involved in the piloting of the survey instruments and the final choice of outcome criteria as well as the derivation of possible applications (guidelines, recommendations for rehabilitants).
In addition, the pandemic is negatively associated with equal participation of vulnerable groups (e.g. persons with physical or psychological handicaps). In the case of medical rehabilitation patients, particular occupational problems make equal participation and social cohesion more difficult: problems such as long-term limited productivity or the threat of exclusion from the labor market (pension for reduced earning capacity), negative employment forecasts and experiences of previously limited social participation are in turn further exacerbated by demographic change and the consequences of the COVID 19 pandemic. These restrictions are also reflected in the increased experience of loneliness. To date, however, there is a lack of a systematic understanding of these circular, dynamic processes and low-threshold, effective approaches to action, effective approaches to action.
The following questions will be empirically investigated:
- How are digital services evaluated regarding feasibility, acceptance and subjective usefulness in light of the current situation?
- Which characteristics of rehabilitants are related to the acceptance and subjective usefulness of digital offers?
- For which patients of rehabilitation is there a need for support in the use of digital services to achieve rehabilitation goals?
- Are there differences in perceived usefulness between services?
- How do people in the welfare state and labor market with disabilities and impairments (rehabilitants) perceive the consequences of the Covid 19 pandemic and the transformation processes?
- How effective are support measures with regard to communication for rehabilitants in supporting equal participation?
- How should support for equal participation be designed in the long term: What What are the consequences for labor market and social policy?
The methodology uses a natural variation design within the Dr. Becker Clinical Group in order to investigate the issues at the highest possible scientific level and to achieve reliable results. The interventions consist of an online depression session as a "flipped classroom" and/or an online lecture with socio-medical content, and/ or a tobacco cessation lecture, which are combined in such a way that the differential effects can be evaluated. For this purpose, a control group is included that does not participate in these interventions (but receives the standard rehabilitation treatment programm). Furthermore, all groups voluntarily receive patient training before rehabilitation with the content of setting "treatment goals" as well as an invitation to pre- and post-surveys.
The survey methods are online surveys (before the treatment=pre (T1); end of treatment=post (T2); end of treatment=post 12 weeks (T3)) by means of UniPark.
The main target variables are reported behavior and well-being (stress/burden of COVID-19 disease or probability of disease, limitations, quality of life, anxiety or depression; pre-post comparison) as well as subjective need (pre) and benefit (post) of the digital services. Further primary target variables are concentrated on social participation, workability and return to work. The theoretical foundation for the selection of target variables and constructs is the Carry-Over Action Model. The sample includes all rehabilitands who undergo a psychosomatic rehabilitation in the hospitals. The planned sample size of the rehabilitants is N = 2,000.
The feasibility is given by the use of an existing care system with cover letters from the patients before the treatment. Possible disturbance variables such as affinity towards technology (which could lead to a lower participation rate among participants with little affinity towards technology) are controlled for and taken into account in the evaluation. Gender and diversity are considered as covariates or moderators in the statistical models.
All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant.
The results of this study will show which digital implementation forms of therapy offers are feasible in terms of benefit and acceptance and can thus contribute to the further development of health care services and medical rehabilitation. This will create the necessary evidence base to include digital offers in the classification of therapeutic services and the therapy standards based on them and thus to establish them in routine care. Furthermore, a guideline for the future integration of these services into the health care services/rehabilitation process will be developed. Due to the standardized combination of analogue and digital therapy parts, therapy goals can be achieved more efficiently on the basis of the validated pedagogical concepts used and with the involvement of fewer human resources. This is not only relevant during the SARS-CoV-2 pandemic, but also with regard to the relevant shortage of qualified personnel. Furthermore, the research basis for digital measures to support social support for social participation will be created. With these findings, similar measures on other groups, for example, persons with disabilities or limitations, can be researched.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of an online depression session as a "flipped classroom" and/or an online lecture with socio-medical content, which are combined in such a way that the differential effects can be evaluated. For this purpose, a control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).
| Arm | Type | Receives |
|---|---|---|
| Partial digital group: depression | Experimental | Behavioral: Training session adressing information and health literacyBurg Online depression session as a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals |
| Partial digital group: social work (social medicine) | Experimental | Behavioral: Training session adressing information and health literacyNOR Online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals |
| Partial digital group: depression + social work | Experimental | Behavioral: Training session adressing information and health literacyJUL Online depression session as a "flipped classroom" and an online lecture with socio-medical content and voluntary low-threshold communication trainings as well as training on rehabilitation goals |
| Control group: only digital training before rehabilitation | Active comparator | Behavioral: Training session adressing information and health literacyMOE Online tobacco cessation a "flipped classroom" and voluntary low-threshold communication trainings as well as training on rehabilitation goals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients before the start of the treatment
- Selected by the clinic
- Invited to participate in the study
Key exclusion criteria (3 listed)
- Inability to read and write
- Severe dementia
- unwillingness to participate in the study and to sign consent form
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 |
|---|---|---|
| Training session adressing information and health literacyThe training sessions are provided online and as alternative to face-to-face treatments which cannot be provided as before due to the safety regulations relating to Covid-19 | Behavioural | Control group: only digital training before rehabilitation, Partial digital group: depression, Partial digital group: depression + social work, Partial digital group: social work (social medicine) |
Primary outcome
Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)
Time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Quantitative online questionnaire Survey using UniPark
Usability and effectiveness of digital interventions
Time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Quantitative online questionnaire Survey using UniPark
Stressors and barriers due to Covid-19
Time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
Quantitative online questionnaire Survey using UniPark
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- BackgroundBaumeister, H., Reichler, L., Munzinger, M., & Lin, J. (2014). The impact of guidance on Internet-based mental health interventions - A systematic review. Internet Interventions, 1(4), 205-215. <br /> Direito, A., Carraça, E., Rawstorn, J., Whittaker, R., & Maddison, R. (2017). mHealth technologies to influence physical activity and sedentary behaviors: behavior change zechniques, systematic review and meta-analysis of randomized controlled trials. Annals of Behavioral Medicine, 51, 226-239. doi: 10.1007/s12160-016-9846-0 <br /> Elbert, N. J., Van Os-Medendorp, H., van Renselaar, W., Ekeland, A. G., Hakkaart-van Roijen, L., Raat, H., … Gma, S. (2014). Effectiveness and cost-effectiveness of eHealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. Journal of Medical Internet Research, 16, e110. doi: 10.2196/jmir.2790 <br /> Fleig, L., Lippke, S., Pomp, S., & Schwarzer, R. (2011). Intervention effects of exercise self-regulation on physical exercise and eating fruits and vegetables: a longitudinal study in orthopedic and cardiac rehabilitation. Preventive Medicine, 53, 182-187. <br /> Fleig, L., Pomp, S., Schwarzer, R., & Lippke, S. (2013). Promoting exercise maintenance: How interventions with booster sessions improve long-term rehabilitation outcomes. Rehabilitation Psychology, 58, 323-333. <br /> Granja, C., Janssen, W., & Johansen, M. A. (2018). Factors determining the success and failure of eHealth interventions: systematic review of the literature. Journal of Medical Internet Research, 20, e10235. doi: 10.2196/10235 <br /> Hong, Z., Li, N., Li, D., Li, J., Li, B., Xiong, W., Lu, L., Li, W., & Zhou, D. (2020). Telemedicine during the COVID-19 pandemic: experiences from Western China. Journal of Medical Internet Research, 22, e19577. <br /> Lippke, S., Preißner, C., & Whittal, A. (2018). Facilitating health literacy and behavior change by computer-tailored interventions. In: A. K. Mayer (Ed.). Health Literacy Across the Life (pp. 39-58). Lengerich: Pabst Science Publishers. <br /> Lustria, M. L. A., Noar, S. M., Cortese, J., Van Stee, S. K., Glueckauf, R. L., & Lee, J. (2013). A meta-analysis of web-delivered tailored health behavior change interventions. Journal of Health Communication: International Perspectives, 18, 1039-1069. doi: 10.1080/10810730.2013.768727 <br /> McNeary, L., Maltser, S., Verduzco-Gutierrez, M. (2020). Navigating coronavirus disease 2019 (Covid-19) in physiatry: a CAN report for inpatient rehabilitation facilities. PM R, 12, 512-515. doi:10.1002/pmrj.12369 <br /> Milne-Ives, M., Lam, C., De Cock, C., Van Velthoven, M. H., & Meinert, E. (2020). Mobile apps for health behaviour change in physical activity, diet, drug and alcohol use, and mental health: a systematic review. JMIR Mhealth Uhealth, 8, e17046. doi: 10.2196/17046 <br /> Padala, P. R., Jendro, A. M., & Padala, K. P. (2020). Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveillance, 6, e18887. <br /> Pérez Sust, P., Solans, O., Fajardo, J.C., Medina Peralta, M., Rodenas, P., Gabaldà, J., Garcia Eroles, L., …, Piera-Jimenez, J. (2020). Turning the crisis into an opportunity: Digital health strategies deployed during the COVID-19 outbreak. JMIR Public Health Surveillance, 6, e19106. <br /> Schuler, M., Murauer, K., Stangl, S., Grau, A., Gabriel, K., Podger, L., . . . Faller, H. (2019). Pre-post changes in main outcomes of medical rehabilitation in Germany: Protocol of a systematic review and meta-analysis of individual participant and aggregated data. BMJ Open, 9. doi:10.1136/bmjopen-2018-023826 <br /> Sheehy, L. M. (2020). Considerations for postacute rehabilitation for survivors of COVID-19. JMIR Public Health Surveillance, 6, e19462. <br /> Storm, V., Dörenkämper, J., Reinwand, D., Wienert, J., De Vries, H., & Lippke, S. (2016). Effectiveness of a web-based computer-tailored multiple-lifestyle intervention for people interested in reducing their cardiovascular risk: A randomized controlled trial. Journal of Medical Internet Research, 18, e78. <br /> Vugts, M. A. P., Joosen, M. C. W., van der Geer, J. E., Zedlitz, A. M. E. E., & Vrijhoef, H. J. M. (2018). The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS ONE, 13, e0196467. https://doi.org/10.1371/journal.pone.0196467 <br /> Weisel, K. K., Fuhrmann, L. M., Berking, M., Baumeister, H., Cuijpers, P., & Ebert, D. D. (2019). Standalone smartphone apps for mental health - a systematic review and meta-analysis. npj Digital Medicine, 2, 1-10.
- Results publication: PubMed 34270444Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Psychosomatic Rehabilitation Patients and the General Population During COVID-19: Online Cross-sectional and Longitudinal Study of Digital Trainings and Rehabilitation Effects. JMIR Ment Health. 2021 Aug 26;8(8):e30610. doi: 10.2196/30610.
- Results publication: PubMed 34501524Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Implementing Digital Trainings within Medical Rehabilitations: Improvement of Mental Health and Synergetic Outcomes with Healthcare Service. Int J Environ Res Public Health. 2021 Aug 25;18(17):8936. doi: 10.3390/ijerph18178936.
- Results publication: PubMed 33831971Dahmen A, Keller F, Kotting L, Derksen C, Lippke S. [Fear of Coronavirus, Intention to Follow the AHA Rules and Risk Perception Regarding Visits to the Doctor: Cross-sectional Study with Patients suffering from Pre-existing Mental Illness]. Gesundheitswesen. 2021 Apr;83(4):274-281. doi: 10.1055/a-1397-7214. Epub 2021 Apr 8. German.
- Results publication: PubMed 34544173Dahmen A, Keller FM, Derksen C, Kotting L, Lippke S. [Which Digital Services do Psychosomatic Rehabilitation Patients Use During the Corona Pandemic and do Interrelations with Anxiety and Depressive Symptoms Exist?]. Psychother Psychosom Med Psychol. 2021 Dec;71(12):508-514. doi: 10.1055/a-1503-5548. Epub 2021 Sep 20. German.
- Results publication: PubMed 35266309Keller FM, Derksen C, Kotting L, Dahmen A, Lippke S. Distress, loneliness, and mental health during the COVID-19 pandemic: Test of the extension of the Evolutionary Theory of Loneliness. Appl Psychol Health Well Being. 2023 Feb;15(1):24-48. doi: 10.1111/aphw.12352. Epub 2022 Mar 9.
- Individual participant dataSharing planned: 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.
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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. principal investigator
Jacobs University Bremen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training session adressing information and health literacy in people with Psychosomatic Disorder and Psychological Distress, run by Jacobs University Bremen gGmbH at 1 site 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 3 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences) (time frame: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453475, which also lists 6 linked publications.
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 15 Apr 2026.