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Psychiatric DisorderCARP-RCTNCT07497763

A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions.

A study testing Brief Case Management intervention and TAU in people with Psychiatric Disorder and Involuntary Psychiatric Hospitalization, run by Stéphane Morandi at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Brief Case Management intervention and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2026to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • To have been involuntarily admitted by a medical doctor;
  • To be aged between 18 and 64 years;
  • To be domiciled in the catchment area of the Centre or West psychiatric sector of the Canton of Vaud;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting
  • Lausanne University Hospital

    Lausanne, Canton of Vaud, 1003

    Stéphane Morandi, +41 21 3140050, stephane.morandi@chuv.ch

    Stéphane Morandi

    Recruiting

Other trials in Switzerland

About this study

Official title: A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions: a Randomised Controlled Trial

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 :

Read more
  • 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).
Read the detailed description

Background: The use of coercion in psychiatry has been increasing for many years, both in Switzerland and abroad. While it is justified by the need to protect the health and safety of the concerned patients, coercion also represents an infringement of their fundamental rights. It can have negative effects on their health and care, for example, by causing post-traumatic stress disorder or leading to a breakdown in care. Having been involuntarily hospitalised in psychiatry is one of the main predictors of compulsory readmission. While numerous interventions have been proposed to limit the use of coercion, very few have been rigorously studied, and even fewer have been shown to be effective. Personal recovery involves leading a satisfying, contributory life, full of hope and meaning, despite the existence of a mental disorder and the resulting limitations. According to the WHO, services should be recovery-oriented to respect and promote human rights. To date, very little work has been done on the links between personal recovery and coercion. A brief case management intervention designed to promote the personal recovery of involuntarily hospitalised psychiatric patients has been developed in partnership with service-users. Its acceptability, feasibility and patients' satisfaction with the intervention were demonstrated in a six-month pilot phase.

Aims: The primary aim of the study is to test, by means of a randomised controlled trial, the effectiveness of the intervention in reducing involuntary readmissions incidence in a population of adult patients involuntarily hospitalised in psychiatry. The secondary aim is to assess the impact of the intervention on patients' personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion.

Methods: 262 patients involuntarily hospitalised in psychiatry will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive, in addition to standard care, a 5-session case management intervention starting within the first two weeks of hospitalisation and lasting a maximum of two months after discharge. During the sessions, patients will discuss their experience of coercion and its impact on their personal recovery. The intervention is designed to enable them to identify and mobilise their resources, improve their self-esteem, restore their confidence in the future and strengthen ties and collaborations with their entourage. They will also be invited to draw up a personal recovery plan. The number of involuntary readmissions at 18 months after inclusion will be measured in both groups as the primary outcome. The shorter-term impact of the intervention on the number of involuntary readmissions will also be assessed at the 6-month follow-up. Changes in personal recovery and other relevant variables, such as self-esteem, self-stigma, post-traumatic stress symptoms, satisfaction with care and exposure to other forms of formal or informal coercion, will also be measured at the 6- and 18-month follow-ups as secondary outcomes. Results will be evaluated on an Intent To Treat basis. Generalized linear models (GLMs) with a Poisson or negative binomial regression, based on overdispersion diagnostics, will be used to determine group differences. Other estimands such as treatment effect for patients who would not experience the intercurrent event will be considered as sensitivity analysis.

Expected results and impact: Promoting personal recovery of involuntarily admitted patients by helping them to develop and implement strategies that improve their mental well-being should mitigate the adverse consequences of coercion and reduce the risk of exposure to new coercive measures. This study will also provide a deeper understanding of the links between personal recovery and coercion.

Being tested
Brief Case Management intervention, TAU
Keywords
coercion, involuntary admission, personal recovery, case management, psychiatry
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Case Management interventionOther

    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.

  • TAUOther

    Standard inpatient and outpatient psychiatric care.

Study groups in NCT07497763
Study groupRoleWhat they receive
Control GroupActive comparatorTreatment as usual (TAU): standard inpatient and outpatient psychiatric care
Receives: Other: TAU
Intervention GroupExperimentalBrief Case Management intervention
Receives: Other: Brief Case Management intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (18)
  1. Number of involuntary readmission(s) (short-term)

    To assess the intervention's shorter-term effect, the number and duration of any involuntary readmission occurred at any hospital of the Canton of Vaud at the 6-month follow-up (T1) will be measured as secondary outcome. Data on involuntary readmissions will be extracted from the Register of Protection Measures (RMP) of the Canton of Vaud and the participants medical records.

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

  2. Recovery Assessment Scale (RAS)

    The French version of the Recovery Assessment Scale is a 24-item, self-report, patient-oriented outcome inventory. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms.

    Developed through participatory action research and narrative analysis, this is to date the most wildly used tool to measure personal recovery. The RAS has shown satisfactory psychometric properties and sensitivity to change over time.

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

  3. Empowerment Scale

    The Empowerment Scale is a 28-item self-report measure assessing personal empowerment as defined by mental health service-users. A total score as well as five specific sub-scores can be calculated: self-esteem; power and powerlessness; community activism and autonomy; optimism and control over the future; righteous anger. This scale has shown excellent reliability and validity.

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

  4. Rosenberg Self-Esteem Scale (RSS)

    The French version of the Rosenberg Self-Esteem Scale, a 10-item inventory measuring self-esteem. This self-report scale has shown satisfactory psychometric properties.

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

  5. Paradox of Self-Stigma scale (PaSS-24)

    The Paradox of Self-Stigma scale is a 24-items French-language self-report scale developed in collaboration with mental health service-users to measure self-stigma and its three related construct of stereotype endorsement, righteous anger and non-disclosure. The PASS-24 has shown good psychometric properties.

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

  6. Beck Hopelessness Scale (BHS)

    The French version of the Beck Hopelessness Scale, is a self-report inventory of 20 true-false items which assess negative expectations about the future on three dimensions: feeling about the future, decrease in motivation and expectations. The BHS has shown good psychometric properties.

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

  7. WHOQOL-BREF Scale

    The French version of the WHOQOL-BREF, a self-report scale including 26 Likert type items, measuring quality of life in four domains: physical health, psychological health, social relationships and environment. The WHOQOL-BREF has shown adequate psychometric properties.

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

  8. International Trauma Questionnaire (ITQ)

    The French version of the International Trauma Questionnaire, is an 18-item self-report scale used to assess Post Traumatic Stress Disorder (PTSD) and Complex Post Traumatic Stress Disorder (C-PTSD) symptoms in adults. A total score can be calculated for the PTSD and DSO subscale. A C-PTSD score can also be calculated. The ITQ has shown good psychometric properties.

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

  9. Pressures in Psychiatry Scale (P-PSY35)

    The French version of the Pressures in Psychiatry Scale, is a 35-item self-report scale developed in collaboration with mental health service-users to assess level of exposure to informal coercion (inducements, persuasions, pressures, threats used to make patients accept therapeutic measures). The P-PSY scale has shown good psychometric properties, especially with an excellent reliability.

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

  10. Coercion Ladder (CL)

    The French version of the Coercion Ladder is a single-item self-report instrument, asking patients to rate their experience of care on a visual analogue scale ranging from 1="minimum use of coercion" to 10="maximum use of coercion".

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

  11. Index of Fairness and the Index of Effectiveness

    The Index of Fairness and the Index of Effectiveness will be used to assess if participants perceived the experienced treatment pressures as fair and effective.

    These two self-administered inventories include four items each.

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

  12. Satisfaction with hospital care (ANQ)

    Satisfaction with hospital care will be measured using the structured satisfaction questionnaire developed by the Swiss National Association for Quality Development in hospitals and clinics (ANQ). This six-item tool assess patients' satisfaction about quality of treatment, information and communication, medication, patient's implication and discharge preparation. The total score of global satisfaction will be computed and used for secondary analyses. Moreover, the ANQ questionnaire includes one-item subscale assessing responders' self-reported health.

    Measured: 2 time point assessment : at baseline (T0) and 6-month follow-up (T1).

  13. Brief INSPIRE Scale

    The Brief INSPIRE scale, is a service user-rated measure of perceived staff support for personal recovery. The Brief INSPIRE consists of five items, one for each CHIME domain. Responders are asked to rate on a five-point Likert scale, from 0="not at all" to 4="very much", how much they feel supported by mental health professionals in each domain of their personal recovery. A total score between 0 and 100 can be computed.

    Measured: 2 time point assessment : at baseline (T0) and 6-month follow-up (T1).

  14. Type and number of other formal coercive measures

    The type and number of other formal coercive measures received during the timeframe of the study (such as seclusion, restraint, and forced medication) will be extracted from the participants' medical records.

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

  15. Number and duration of any voluntary readmission occurred during the study

    The number and duration of any voluntary readmission occured during the timeframe of the study will be extracted from the participants' medical records.

    Measured: 2 time point assessment : at 6-month follow-up (T1) and 18-month follow-up (T2).

  16. Exposure to other civil and legal measures

    This structured questionnaire asks participants to indicate whether or not they have been exposed to any other civil measures (such as guardianship, authorised representative, advance directives) and penal measures. The items are presented in a dichotomous format, with a separate "yes" or "no" response for each tool.

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

  17. Use of recovery tools

    This structured questionnaire asks participants to indicate whether or not they have previously used one or more recovery tools (such as Difficulties and Needs Self-Assessment Tool - ELADEB; Joint Crisis Plan - PCC; and the Recovery plan - REVIM) by selecting the corresponding response option for each instrument. The items are presented in a dichotomous format, with a separate "yes" or "no" response for each tool.

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

  18. Psychiatric follow-up within the last three months

    This structured questionnaire asks participants to indicate whether or not they have received psychiatric follow-up within the past three months. For each type of follow-up, participants are asked to select either "yes" or "no" for the following providers: psychologist, psychiatrist, nurse, general practitioner, or other. If "other" is selected, participants are asked to specify the type of follow-up received.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Jul 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Monocentric single-blinded randomised controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497763
Sponsor's protocol ID
2026-00250
Other IDs
10.005.859
Acronym
CARP-RCT
Status last verified
Oct 2026
First submitted
23 Mar 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will only share anonymized sensitive human data for which there are a proper consent of the participants for Open Research data sharing in line with legal, ethical and confidentiality issues. We will ensure that shared data do not contain information that identifies, or that could be used in conjunction with other publicly available information to identify personally an individual. Sensitive human data that cannot be anonymized will be shared under restricted access.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Case Management intervention and TAU in people with Psychiatric Disorder and Involuntary Psychiatric Hospitalization, run by Stéphane Morandi at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephane Morandi (+41 21 3140050, stephane.morandi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of involuntary readmission(s) (long-term) (time frame: Assessed at 18-month follow-up (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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