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

Psychosocial Distress Clinical Trial

— SomPsyNet  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04269005
• Other study ID #: 2019-01724; me19Schaefert
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Psychosocial Distress

Intervention

Other:
• Implementation of the SCCM
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.

Locations

Country	Name	City	State
Switzerland	Bethesda Spital AG	Basel
Switzerland	Department of Psychosomatics/ Division of Medicine; University Hospital of Basel	Basel
Switzerland	Universitäre Altersmedizin Felix Platter	Basel
Switzerland	Universitätsspital Basel - Frauenklinik	Basel

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Bethesda Krankenhaus, Gesundheitsdepartement Basel-Stadt, Gesundheitsförderung Schweiz, GFCH, Institute of Pharmaceutical Medicine (ECPM), University of Basel, Swiss Tropical & Public Health Institute, University Department of Geriatric Medicine FELIX PLATTER

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Depression	Current depressive disorders assessed by the eight-item Patient Health Questionnaire depression scale (PHQ-8)	Baseline to 6 months follow-up
Secondary	Change in Generalized Anxiety Disorder	Generalized Anxiety Disorder assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)	Baseline to 6 months follow-up
Secondary	Change in Somatic symptom disorder	Psychological features of Somatic Symptom Disorder (SSD) assessed by the 12-item Somatic Symptom Disorder Scale (SSD-12)	Baseline to 6 months follow-up
Secondary	Change in Somatic symptom burden	Somatic symptom severity assessed by the 8-item Somatic Symptom Scale-8 (SSS-8)	Baseline to 6 months follow-up
Secondary	Change in Quality of life	"Health-related quality of life assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D- 5L)"	Baseline to 6 months follow-up
Secondary	Change in health related quality of life	Health-related quality of life assessed by the Physical Health Component Summary score of the SF-36	Baseline to 6 months follow-up
Secondary	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	6 months to 3 years following initiation of the SCCM in a given patient
Secondary	Resilience	Resilience assessed by the Resilience Scale for Adults (RSA)	6 months follow-up
Secondary	Social support	Social support assessed by the Oslo social support scale (OSSS-3)	6 months follow-up