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Cardiovascular DiseasesNCT06651164

Psychosomatic Risk Screening

A study testing psychosocial risk screening in people with Cardiovascular Diseases, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mental health problems are common in terms of lifetime prevalence and often occur in combination with chronic physical illnesses. It is therefore reasonable to assume that there is considerable mental health comorbidity among inpatients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
psychosocial risk screening
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteGermany
Study dates
1 Jun 2024to 7 Feb 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

  • The target group are all adult (age >=18 years) physically ill patients capable of giving consent on the pilot ward.

Who cannot join

  • Acute mental illnesses that require immediate further treatment (e.g., active suicidal ideation, acute psychotic state)
  • The length of stay is too short to carry out a psychosomatic and/or a social services consultation. This can be assumed if the expected length of stay is less than or equal to three days.
  • Insufficient knowledge of the German language.
  • Cognitive impairment or significant hearing impairment that makes it impossible for the person carrying out the screening and answering the questions adequately.
  • in case of re-admission if patient has already been included in the trial

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Heidelberg University Clinic - Medical Clinic

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: Psychosomatic Risk Screening in the Inpatient Care of Physically Ill Patients: a Feasibility Study

Mental health problems are common in terms of lifetime prevalence and often occur in combination with chronic physical illnesses. It is therefore reasonable to assume that there is considerable mental health comorbidity among inpatients. A recent retrospective analysis of patient data from a tertiary care internal medicine clinic also showed that the length of stay in hospital was longer for patients with mental comorbidity. This effect was particularly pronounced in the case of severe physical multimorbidity.

Our hypothesis is that the implementation of psychosocial risk screening as part of the inpatient admission process is suitable to identify the need for psychosomatic and social service counselling and treatment at an early stage and to address it appropriately from a medical, psychological and social service perspective in order to reduce the length of inhouse treatment.

Read more

Two consecutive studies are planned to test this hypothesis. The present study is a randomised feasibility study. Patients will be enrolled and assigned to the intervention or control group. Only the intervention group will receive screening. The psychosomatic and social screening will be differentiated according to previously defined risk categories. In some cases, established standardised questionnaires (PHQ-4, Audit-C, Clinical Frailty Scale, Six Item Screener) are used. In other cases, we have developed our own questions. Patients are screened by physicians or students in their practical year when they are admitted to our pilot ward. If the psychosomatic screening is positive and the patient agrees, they are referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by the social service.

The main objective of this study is to obtain informed consent from 30% of the eligible patients as a parameter for the feasibility and acceptance of such screening within an integrated psychosomatic and social service care concept. A study period of 3 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics. The main study, which has not yet been applied for, is planned as a randomised intervention study. The main objective criterion will be to reduce the length of stay through screening and, if necessary, timely psychosomatic or social counselling.

Read the detailed description

Mental health problems are common in terms of lifetime prevalence and often occur in combination with chronic physical illnesses. Mental comorbidities in physically ill patients lead to higher morbidity and mortality, greater demands on the healthcare system and higher treatment costs.

Among medical inpatients it can therefore be assumed that there is considerable mental comorbidity. In a large retrospective analysis of around 28,500 patient data sets from the Department of Internal Medicine at Heidelberg University Hospital, we could show that the length of stay in hospital for patients with mental comorbidity was extended by a total of 2 days when compared with patients who had no documented mental comorbidity. This effect was particularly pronounced in the case of major physical multimorbidity. In addition to previously documented psychiatric and psychosomatic diseases, there is a tremendous lack of recognition and diagnosis of relevant mental comorbidities. It has also been shown that other non-acute medical factors, such as functional limitations, impairment of activities of daily living, frailty, cognitive limitations or the lack of a receiving care facility, prolong the length of stay.

To address these problems in health care, some guidelines recommend systematic screening for mental and functional risk-factors, but still this has not been implemented in routine inpatient medical wards. The implementation of psychosomatic risk screening as part of the inpatient admission process could be suitable for detecting the need for psychosomatic and social service at an early stage and addressing it accordingly with psychotherapy, psychopharmacy and qualified social support. It may also be possible to reduce the length of stay in hospital. In this pilot project, a psychosocial risk screening with subsequent psychosomatic assessment by a consultant and introduction to social services is to be evaluated with regard to the feasibility of integration into ward procedures and acceptance by patients. The study is designed as a randomized feasibility study. Patients are included in the study on admission to a medical ward and randomly assigned to the intervention or the control group. The intervention group receives the screening and if necessary subsequent further care, the control group does not receive screening.

Screening focuses on previously defined psychosocial risk categories:

As part of the psychosomatic screening, the risk categories of sleep disorder and psychotropic drug use, depression, anxiety disorder, subjective disease burden, risky alcohol consumption, frailty and cognitive impairment are examined based on previous results.

For the social services screening, relevant consultation and intervention needs such as a general need for advice on social law issues, a lack of health insurance, a lack of financial security, the presence of a legal guardian, a need for care at home, an existing or possibly increased level of care and interest in follow-up treatment or rehabilitation measures are queried.

In the event of a conspicuous psychosomatic screening, a consecutive assessment is carried out by a psychosomatic consultant if consent is given. In the event of a conspicuous social services screening, a social worker is called. If the screening is negative, there will be no further assessment or consultation by the respective services at this time.

The current study serves to prepare a larger randomized trial to test the effect of a psychosocial risk screening together with a defined care path on the reduction of length of stay in patients with medical diseases.

Being tested
psychosocial risk screening
Keywords
psychosocial risk factors
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychosocial risk screeningDiagnostic test

    • combined tablet-based screening questionnaire for psychosomatic screening and social service screening
    • in case of positive psychosomatic or social service screening subsequent psychosomatic and / or social service consultation
Study groups in NCT06651164
Study groupRoleWhat they receive
Intervention: psychosocial risk screening conductedExperimentalPatients in the intervention group are interviewed during admission on possible risk factors using the tablet-based screening questionnaire. The survey takes about 10 minutes. Once the screening has been completed, the results are immediately evaluated electronically and can be viewed by the person carrying out the screening. The patient is informed of the result (conspicuous/not conspicuous). If the psychosomatic screening is positive, the patient is asked if she/he is willing to be visited by a psychosomatic consultant. This contact will last about 15-45 minutes. If the social services screening is positive, the social services will introduce themselves in any case. Depending on the needs for regulation or counseling, this will result in a contact of 10-45 minutes. We use established and validated metrics and questionnaires.
Receives: Diagnostic Test: psychosocial risk screening
Control: psychosocial risk screening is not conductedNo interventionPatients assigned to the control group will be treated as usual. Besides medical treatment this may also include consultations from a psychosomatic specialist and/or a social worker if the patient asks for it or the staff deems it necessary.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance of study participation

    The main target criterion of the feasibility study is the rate of patients accepting study We will determine the rate of eligible patients accepting study participation as the main target criterion of the feasibility study.

    Measured: On admission day (day 1) or first possible day of patient consultation

Secondary outcomes (6)
  1. Compliance with screening procedure/ result

    We will determine the rate of screening results that are implemented accordingly by the staff (psychosomatic consultation, social service consultation)

    Measured: At day 1 /day of risk screening

  2. Compliance with screening recommendations

    We will determine the rate of study patients willing to meet with a psychosomatic consultant and / or social worker, if indicated by risk screening

    Measured: At day 1 /day of risk screening

  3. Loss to follow up

    We will determine the rate of study participants with completed follow up assessment

    Measured: 3 month after discharge from the ward

  4. Compliance with all study procedures

    We will determine the rate of study patients with fully completed study procedures (electronic risk screening, consultation with psychosomatic expert and / or social worker, follow up assessment)

    Measured: 3 month after discharge from the ward

  5. Patient's physical health at the time of follow up

    We will determine physical health using a visual analogue scale (VAS)

    Measured: 3 month after discharge from the ward

  6. Patient's general wellbeing at the time of follow up

    We will determine general wellbeing using a visual analogue scale (VAS)

    Measured: 3 month after discharge from the ward

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start1 Jun 2024
  3. Primary completion2 Oct 2024
  4. Study completion7 Feb 2025

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651164
Sponsor's protocol ID
S-301/2024
Status last verified
Mar 2025
First submitted
22 Jul 2024
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stahl-Toyota S, Nikendei C, Nagy E, Bonsel S, Rollmann I, Unger I, Szendrodi J, Frey N, Michl P, Muller-Tidow C, Jager D, Friederich HC, Hochlehnert A. Interaction of mental comorbidity and physical multimorbidity predicts length-of-stay in medical inpatients. PLoS One. 2023 Jun 22;18(6):e0287234. doi: 10.1371/journal.pone.0287234. eCollection 2023.

    PubMed 37347745
  • Feder SC, Simsek Z, Simon JJ, Hartmann M, Bruns B, Bugaj TJ, Hoch J, Dugas M, Friederich HC. Psychosocial risk screening in the inpatient care of physically ill patients: study protocol for a feasibility study. BMJ Open. 2026 Mar 18;16(3):e102470. doi: 10.1136/bmjopen-2025-102470.

    PubMed 41857846

Questions about this trial

What is this clinical trial studying?

A study testing psychosocial risk screening in people with Cardiovascular Diseases, run by Heidelberg University 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 1 inclusion and 5 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 18 Mar 2025. 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?

Acceptance of study participation (time frame: On admission day (day 1) or first possible day of patient consultation). 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 NCT06651164, which also lists 2 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 18 Mar 2025.

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