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| ID | Type | Description | Link |
|---|---|---|---|
| 10.005.859 | Other Grant/Funding Number | Swiss National Science Foundation (SNSF) |
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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
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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 :
Participants will be randomly assigned to either the control or the intervention group, accordingly they will be asked to take part in:
Control Group:
Intervention Group :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Treatment as usual (TAU): standard inpatient and outpatient psychiatric care |
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| Intervention Group | Experimental | Brief Case Management intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Case Management intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephane Morandi | Contact | +41 21 3140050 | stephane.morandi@chuv.ch | |
| Benedetta Silva | Contact | +41 21 314 45 92 | Benedetta.Silva@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane Morandi | Centre Hospitalier Universitaire Vaudois, CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital | Lausanne | Canton of Vaud | 1003 | Switzerland |
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.
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Monocentric single-blinded randomised controlled trial
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| TAU | Other | Standard inpatient and outpatient psychiatric care. |
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| Assessed at 6-month follow-up (T1). |
| 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. | 3 time point assessment: at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2). |
| 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. | 3 time point assessment: at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 3 time point assessment: at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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". | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month (T2). |
| 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. | 3 time point assessment: at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2). |
| 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. | 2 time point assessment : at baseline (T0) and 6-month follow-up (T1). |
| 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. | 2 time point assessment : at baseline (T0) and 6-month follow-up (T1). |
| 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. | 3 time point assessment: at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 2 time point assessment : at 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| 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. | 3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2). |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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