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Clinical Trials/NCT06320457
NCT06320457
Completed
N/A

Supporting People Involuntarily Admitted to a Psychiatric Hospital Through a Brief Case Management Intervention That Promotes Personal Recovery and Reduces the Negative Effects of Coercion: a Pilot Study

University of Lausanne Hospitals1 site in 1 country26 target enrollmentApril 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychiatric Disorder
Sponsor
University of Lausanne Hospitals
Enrollment
26
Locations
1
Primary Endpoint
Eligibility rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:

  • Is the case management intervention acceptable and feasible?
  • What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?

Participants will be asked to take part in:

  • the five sessions of the case management intervention;
  • two evaluation sessions (pre and post-intervention);
  • a final in-depth semi-structured interview (optional).
Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
January 21, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Stéphane Morandi

Deputy Head of the Community Psychiatry Service, PD & MER

University of Lausanne Hospitals

Eligibility Criteria

Inclusion Criteria

  • To have been involuntarily admitted by a medical doctor
  • To be aged between 18 and 65 years

Exclusion Criteria

  • Patients unable to provide written consent due to a lack of discernment
  • Patients unable to speak French well enough to participate in the study without the help of an interpreter

Outcomes

Primary Outcomes

Eligibility rate

Time Frame: From start of study recruitment through study recruitment completion, on average 6 months

Number of eligible patients/number of patients involuntarily hospitalised on site during study period as reported in a structured flowchart by the case managers after each site visit

Participation rate

Time Frame: From start of study recruitment through study recruitment completion, on average 6 months

Number of patients accepting to participate/number of approached patients as reported in a structured flowchart by the case managers after each site visit and based on the number of signed consent forms

Drop-out rate

Time Frame: Post-intervention, up to 1 month post hospital discharge

Number of patients who completed the programme/number of recruited patients as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient

Intervention dosage

Time Frame: Post-intervention, up to 1 month post hospital discharge

Mean number of sessions delivered per participant as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient

Missing data rates

Time Frame: At the end of the study, on average 9 months after the inclusion of the first participant

Percentage of missing data

Number of unexpected adverse events

Time Frame: Up to 1 week after hospital admission through up to 1 month post hospital discharge

Number of unexpected adverse events related to the intervention reported in a structured form by the case managers or the investigator

Participants' acceptance and degree of satisfaction

Time Frame: Post-intervention, up to 1 month post hospital discharge

Participants' acceptance and degree of satisfaction with both the intervention and the research process qualitatively assessed through semi-structured interviews

Implementation barriers and facilitating factors

Time Frame: After the last included participant final evaluation, on average 8 months after the inclusion of the first participant

Barriers and facilitating factors encountered throughout the implementation process as described by some members of the hospital team, during in-depth semi-structured interviews.

Secondary Outcomes

  • Empowerment Scale(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Brief INSPIRE scale(Post-intervention, up to 1 month post hospital discharge)
  • Recovery Assessment Scale (RAS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Coercion Ladder (CL)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Satisfaction with hospital care(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • The Paradox of Self-Stigma scale (PaSS-24)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Index of fairness and Index of effectiveness(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Rosenberg Self-Esteem Scale (RSS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • Beck Hopelessness Scale (BHS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • WHOQOL-BREF(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
  • International Trauma Questionnaire (ITQ)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))

Study Sites (1)

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