NCT07497763

Brief Summary

The goal of this randomized control trial is to assess the effectiveness of a Brief Case Management (BCM) intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital. The main questions it aims to answer are :

  • Does the Brief Case Management intervention reduce the incidence of involuntary readmission18 months after the initial involuntary hospitalisation?
  • What impact does the Brief Case Management intervention have on patients' involuntary readmission 6 months after the initial involuntary hospitalisation, as well as on their personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion? Participants will be randomly assigned to either the control or the intervention group, accordingly they will be asked to take part in: Control Group:
  • Three evaluation sessions (baseline, 6 and 18 months follow-up); Intervention Group :
  • Three evaluation sessions (baseline, 6 and 18 months follow-up);
  • The 5 sessions of the brief case management intervention (6th session optional).

Trial Health

63
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Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Nov 2029

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3.4 years

First QC Date

March 23, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

coercioninvoluntary admissionpersonal recoverycase managementpsychiatry

Outcome Measures

Primary Outcomes (1)

  • Number of involuntary readmission(s) (long-term)

    The study's primary outcome will be the number of involuntary readmissions occurred at any hospital of the Canton of Vaud 18 months after study enrolment (T2). Data on involuntary readmissions will be extracted from the Register of Protection Measures (RMP) of the Canton of Vaud and the participants medical records.

    Assessed at 18-month follow-up (T2).

Secondary Outcomes (18)

  • Number of involuntary readmission(s) (short-term)

    Assessed at 6-month follow-up (T1).

  • Recovery Assessment Scale (RAS)

    3 time point assessment: at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2).

  • Empowerment Scale

    3 time point assessment: at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).

  • Rosenberg Self-Esteem Scale (RSS)

    3 time point assessment : at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2).

  • Paradox of Self-Stigma scale (PaSS-24)

    3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).

  • +13 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Treatment as usual (TAU): standard inpatient and outpatient psychiatric care

Other: TAU

Intervention Group

EXPERIMENTAL

Brief Case Management intervention

Other: Brief Case Management intervention

Interventions

The BCM 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. It is provided by a nurse or social worker case manager. Developed in collaboration with people who have experienced coercion, the intervention starts during the hospital stay, at the latest two weeks after admission, and lasts for a maximum of two months after discharge. The intervention consists of five sessions, the order of which may vary according to the specific needs of the patient: Session 1: Definition of "personal recovery" and impact of coercion on it Session 2 and 3: Elaboration of the Personal Recovery Plan (PRP) Session 4: Network meeting to discuss the PRP Session 5: Finalisation of the PRP For those who request it, an additional session can be arranged after three months to monitor progress and eventually adjust the recovery plan.

Intervention Group
TAUOTHER

Standard inpatient and outpatient psychiatric care.

Control Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To have been involuntarily admitted by a medical doctor;
  • To be aged between 18 and 64 years;
  • To domiciled in the Greater Lausanne area;

You may not qualify if:

  • Patients with an organic mental disorder (F0, ICD-10);
  • Patients with intellectual disability (F7, ICD-10);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1003, Switzerland

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Stéphane Morandi

    Centre Hospitalier Universitaire Vaudois, CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Monocentric single-blinded randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Head of the Community Psychiatry Service, PD & MER

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations