NCT04269005

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2020Jun 2026

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6.1 years

First QC Date

February 11, 2020

Last Update Submit

September 19, 2023

Conditions

Psychosocial Distress

Keywords

mental healthmental disordermental comorbiditymental-somatic multimorbidity"stepped and collaborative care model" (SCCM)

Outcome Measures

Primary Outcomes (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'

    Baseline to 6 months follow-up

Secondary Outcomes (9)

  • Change in Depression

    Baseline to 6 months follow-up

  • Change in Generalized Anxiety Disorder

    Baseline to 6 months follow-up

  • Change in Somatic symptom disorder

    Baseline to 6 months follow-up

  • Change in Somatic symptom burden

    Baseline to 6 months follow-up

  • Change in Quality of life

    Baseline to 6 months follow-up

  • +4 more secondary outcomes

Study Arms (2)

Treatment as usual

NO INTERVENTION

phase 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 condition

EXPERIMENTAL

phase 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.

Other: Implementation of the SCCM

Interventions

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.

Intervention condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitäre Altersmedizin Felix Platter

Basel, 4002, Switzerland

Location

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

Basel, 4031, Switzerland

Location

Universitätsspital Basel - Frauenklinik

Basel, 4031, Switzerland

Location

Bethesda Spital AG

Basel, 4052, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 34253168BACKGROUND

  • 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.

    PMID: 35592378BACKGROUND

  • 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.

    PMID: 37996236DERIVED

MeSH Terms

Conditions

Psychological Well-BeingMental Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Gunther Meinlschmidt, Prof. Dr. rer. nat.

    Department of Psychosomatic Medicine, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Hospital employees who will assign patients to the wards and clusters are blinded to randomization. Blinding of staff involved in the recruitment process is limited as phase 1 and phase 2 will consist of different study information and consent sheets. Trained staff will perform the follow-up assessment, and we intend to blind them regarding study phase allocation of the patients (if procedural aspects allow it).
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

June 8, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Access Criteria
Only upon collection of all important consents and upon approval of the responsible ethics committee(s), the requested data will be transferred to the applicants. Third parties have to confirm and provide evidence to comply with all relevant Swiss and cantonal laws and regulations (especially regarding data protection and Human Research), as well as all obligations and regulations set out in the documents and contracts related to SomPsyNet. Fees may apply to cover expenses related to data reuse. Requests to access the datasets should be directed to Gunther Meinlschmidt, gunther.meinlschmidt@unibas.ch

Locations

CH(4)