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Psychosocial DistressSomPsyNetNCT04269005

SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care

A study testing Implementation of the SCCM in people with Psychosocial Distress, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to evaluate the impact of the "stepped and collaborative care model" (SCCM) on health-related quality of life in somatic hospital patients with psychosocial distress. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychosocial Distress
What is being tested?
Implementation of the SCCM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
4 sitesSwitzerland
Study dates
8 Jun 2020to 30 Jun 2026
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 from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals)

Who cannot join

  • Inability to understand and speak German or any other language at which study is tailored at that point in time
  • Inability to give informed consent by himself / herself
  • Inability to follow the procedures of the study, e.g. due to severe medical / clinical limitations
  • Need for immediate support as indicated by the risk of current suicidality or attempted suicide
  • Oncological condition
  • Already participated in the SomPsyNet project on the occasion of a previous hospitalization
  • Confirmed current COVID-19 disease at time of screening for exclusion criteria
  • Being hospitalized under the medical supervision of services of a ward that is not part of one of the SomPsyNet study clusters ('original ward'), but physically located in rooms of a ward contributing to one of the study clusters only because of lack of space in the original ward

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Universitäre Altersmedizin Felix Platter

    Basel, 4002

  • Department of Psychosomatics/ Division of Medicine; University Hospital of Basel

    Basel, 4031

  • Universitätsspital Basel - Frauenklinik

    Basel, 4031

  • Bethesda Spital AG

    Basel, 4052

Other trials in Switzerland

About this study

This study is to evaluate the impact of the "stepped and collaborative care model" (SCCM) on health-related quality of life in somatic hospital patients with psychosocial distress.

Read the detailed description

Given the burden of psychosocial distress, the public health relevance, and the current standard of health care, new approaches to a model of care for patients with mental-somatic multimorbidity are urgently needed. SomPsyNet is a comprehensive healthcare project for patients from somatic hospitals that promotes the prevention of psychosocial distress by establishing a stepped and collaborative care network in Basel-Stadt, Switzerland and may therefore help to counteract against the described lack of care.

SomPsyNet is a "stepped and collaborative care model" (SCCM) including a Psychosomatic-psychiatric consultation and liaison Service (CL Service) and post hospital intervention supported by a collaborative network structure. It aims to identify patients with psychosocial distress at an early stage during their hospital stay in a standardized way.

Implementation of the SCCM within this study using the stepped-wedge cluster randomized trial (SW-CRT) design will take place in phases:

  • SomPsyNet phase 0: treatment as usual (TAU) in combination with the baseline and follow-up survey in a distressed focus sample.
  • SomPsyNet phase 1: TAU in combination with the baseline survey, implementation of screening questions stage 1 ('baseline distress information from professionals', without consequence) in hospital routine and follow-up survey in a distressed focus sample.
  • SomPsyNet phase 2 refers to the implementation of the SCCM: baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.
Being tested
Implementation of the SCCM
Keywords
mental health, mental disorder, mental comorbidity, mental-somatic multimorbidity, "stepped and collaborative care model" (SCCM)
Medical subject headings
Psychological Well-Being, Mental Disorders

What participants receive

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

  • Implementation of the SCCMOther

    Implementation of the SCCM includes a baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.

Study groups in NCT04269005
Study groupRoleWhat they receive
Treatment as usualNo interventionphase 0: Treatment as usual in combination with baseline and follow-up Survey but without any screening procedures (facilitating the study as a run-in phase to establish study procedures). phase 1: randomized and main control condition with TAU + collection of information on psychosocial distress in the baseline Intervention effects will be estimated, using the distressed focus sample, contrasting Phase 2 vs. Phase 1. We intend to conduct additional statistical analyses to compare data from phases 2 and 1 vs. phase 0 to estimate potential effects of introducing parts of the screening 1 without consequences.
Intervention conditionExperimentalphase 2: implementation of the SCCM The intervention (SSCM) will be implemented step-wise in predefined sections at all three sites using a stepped-wedge cluster randomized trial design. Clusters will be randomized to different sequences that dictate the timing at which each cluster will switch from the control to the intervention condition.
Receives: Other: Implementation of the SCCM

What is being measured

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

  1. Change in health related quality of life

    Health related quality of life will be assessed with the 'Mental Health Component Summary score' of the Short Form-36 (SF-36). The SF-36 consists of 36-Items to measure health-related quality of life using eight concepts (physical functioning (PF, 10 items), physical role functioning (RP, 4 items), bodily pain (BP, 2 items), general health perception (GH, 5 items), vitality (VT, 4 items), social role functioning (SF, 2 items), emotional role functioning (RE, 3 items) and mental health (MH, 5 items) to measure the 'Mental Health Component Summary score'

    Measured: Baseline to 6 months follow-up

Secondary outcomes (9)

  1. Change in Depression

    Current depressive disorders assessed by the eight-item Patient Health Questionnaire depression scale (PHQ-8)

    Measured: Baseline to 6 months follow-up

  2. Change in Generalized Anxiety Disorder

    Generalized Anxiety Disorder assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)

    Measured: Baseline to 6 months follow-up

  3. Change in Somatic symptom disorder

    Psychological features of Somatic Symptom Disorder (SSD) assessed by the 12-item Somatic Symptom Disorder Scale (SSD-12)

    Measured: Baseline to 6 months follow-up

  4. Change in Somatic symptom burden

    Somatic symptom severity assessed by the 8-item Somatic Symptom Scale-8 (SSS-8)

    Measured: Baseline to 6 months follow-up

  5. Change in Quality of life

    "Health-related quality of life assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D- 5L)"

    Measured: Baseline to 6 months follow-up

  6. Change in health related quality of life

    Health-related quality of life assessed by the Physical Health Component Summary score of the SF-36

    Measured: Baseline to 6 months follow-up

  7. Health economics

    total costs of hospital treatment including additional medical, psychiatric or physiotherapeutic treatment during patient's hospital stay; follow-up costs at treating hospitals; healthcare costs, relevant sub-categories of costs and medical resource use based on health insurance claims data; indirect costs due to reduced productivity

    Measured: 6 months to 3 years following initiation of the SCCM in a given patient

  8. Resilience

    Resilience assessed by the Resilience Scale for Adults (RSA)

    Measured: 6 months follow-up

  9. Social support

    Social support assessed by the Oslo social support scale (OSSS-3)

    Measured: 6 months follow-up

Timeline

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

  1. First posted13 Feb 2020
  2. Study start8 Jun 2020
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269005
Sponsor's protocol ID
2019-01724; me19Schaefert
Other IDs
2019
Acronym
SomPsyNet
Status last verified
Sep 2023
First submitted
11 Feb 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets being held by the SomPsyNet project are not readily available. In the case of inquiries by third parties that wish to reuse data SomPsyNet data after an embargo period, the following procedure is planned. Researchers interested in the data may submit a project synopsis addressed to the publications committee of the SomPsyNet project and will have to obtain authorization from the responsible ethics committee as ordained in the Ordinance of 20 September 2013 on Human Research with the exception of Clinical Trials (Human Research Ordinance, HRO). The publication committee will review the project synopsis and will answer the formal requests of applicants.

Publications

  • Aebi NJ, Caviezel S, Schaefert R, Meinlschmidt G, Schwenkglenks M, Fink G, Riedo L, Leyhe T, Wyss K; SomPsyNet Consortium. A qualitative study to investigate Swiss hospital personnel's perceived importance of and experiences with patient's mental-somatic multimorbidities. BMC Psychiatry. 2021 Jul 12;21(1):349. doi: 10.1186/s12888-021-03353-5.

    PubMed 34253168

  • Aebi NJ, Fink G, Wyss K, Schwenkglenks M, Baenteli I, Caviezel S, Studer A, Trost S, Tschudin S, Schaefert R, Meinlschmidt G; SomPsyNet Consortium. Association of Different Restriction Levels With COVID-19-Related Distress and Mental Health in Somatic Inpatients: A Secondary Analysis of Swiss General Hospital Data. Front Psychiatry. 2022 May 3;13:872116. doi: 10.3389/fpsyt.2022.872116. eCollection 2022.

    PubMed 35592378

  • Meinlschmidt G, Frick A, Baenteli I, Karpf C, Studer A, Bachmann M, Dorner A, Tschudin S, Trost S, Wyss K, Fink G, Schwenkglenks M, Caviezel S, Rocco T, Schaefert R; SomPsyNet consortium. Prevention of psychosocial distress consequences in somatic hospital inpatients via a stepped and collaborative care model: protocol of SomPsyNet, a stepped wedge cluster randomised trial. BMJ Open. 2023 Nov 23;13(11):e076814. doi: 10.1136/bmjopen-2023-076814.

    PubMed 37996236

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of the SCCM in people with Psychosocial Distress, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.

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 8 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. 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?

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?

Change in health related quality of life (time frame: Baseline to 6 months follow-up). 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 NCT04269005, which also lists 3 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 21 Sep 2023.

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