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Clinical Trials/NCT04269005
NCT04269005
Active, Not Recruiting
N/A

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

University Hospital, Basel, Switzerland4 sites in 1 country2,500 target enrollmentJune 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosocial Distress
Sponsor
University Hospital, Basel, Switzerland
Enrollment
2500
Locations
4
Primary Endpoint
Change in health related quality of life
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2020
End Date
June 30, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in health related quality of life

Time Frame: Baseline to 6 months follow-up

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'

Secondary Outcomes

  • 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 health related quality of life(Baseline to 6 months follow-up)
  • Change in Quality of life(Baseline to 6 months follow-up)
  • Health economics(6 months to 3 years following initiation of the SCCM in a given patient)
  • Resilience(6 months follow-up)
  • Social support(6 months follow-up)

Study Sites (4)

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