A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital

NCT06320457 | Completed DMC

• 1 other identifier: 2024-00095
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychiatric Disorder; Involuntary Psychiatric Hospitalization

Keywords

coercion; involuntary admission; personal recovery; case management; psychiatry

Outcome Measures

Primary Outcomes (8)

• Eligibility rate

  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

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

• Participation rate

  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

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

• Drop-out rate

  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

  Post-intervention, up to 1 month post hospital discharge

• Intervention dosage

  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

  Post-intervention, up to 1 month post hospital discharge

• Missing data rates

  Percentage of missing data

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

• Number of unexpected adverse events

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

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

• Participants' acceptance and degree of satisfaction

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

  Post-intervention, up to 1 month post hospital discharge

• Implementation barriers and facilitating factors

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

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

Secondary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Intervention group

EXPERIMENTAL

Brief case management intervention group

Other: Brief case management intervention

Interventions

Brief case management intervention OTHER

The brief case management intervention aims to support patients during the difficult phase of involuntary hospitalisation and reduce the impact of this short-term event on their long-term recovery process. The intervention starts during the hospital stay, at the latest one week after admission, and lasts for a maximum of one month after discharge. The intervention consists of five sessions, the order of which may vary according to the specific needs of the patient: 1. Personal account of involuntary hospitalisation and its consequences 2. Presentation of the personal recovery model and the tools to promote it and prevent coercion 3. Introduction to the personal recovery plan 4. Network meeting and discussion on "dignity of risk" 5. Personal recovery plan

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1003, Switzerland

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Charles Bonsack

  Centre Hospitalier Universitaire Vaudois, CHUV

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of the Community Psychiatry Service, PD & MER

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 20, 2024
• Study Start: April 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: January 21, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)