Psychiatric DisorderCARPNCT06320457
A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital
A study testing Brief case management intervention in people with Psychiatric Disorder and Involuntary Psychiatric Hospitalization, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Disorder, Involuntary Psychiatric Hospitalization
- What is being tested?
- Brief case management intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Apr 2024to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have been involuntarily admitted by a medical doctor
- To be aged between 18 and 65 years
Who cannot join
- 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.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1003
About this study
Official title: 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
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?
Read more
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).
- Being tested
- Brief case management intervention
- 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 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:
- Personal account of involuntary hospitalisation and its consequences
- Presentation of the personal recovery model and the tools to promote it and prevent coercion
- Introduction to the personal recovery plan
- Network meeting and discussion on "dignity of risk"
- Personal recovery plan
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Brief case management intervention group Receives: Other: Brief case management intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-intervention, up to 1 month post hospital discharge
Missing data rates
Percentage of missing data
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
The French validated version of the Recovery Assessment Scale (RAS), a 24-item, patient-oriented outcome inventory which assesses personal recovery on a five-point Likert scale ranging from 1="strongly disagree" to 5="strongly agree". 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. Both the total score and the five sub-scores are used in the study. Higher scores correspond to better recovery.
Measured: 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
The validated Empowerment Scale, a 28-item measure assessing personal empowerment as defined by mental health service-users on a four-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score is used for the study. Higher scores correspond to higher empowerment.
Measured: 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)
The French validated version of the Rosenberg Self-Esteem Scale (RSS), a very short 10-item inventory measuring self-esteem on a four-point Likert scale from 1="strongly disagree" to 4="strongly agree". The RSS total score may range between 10 and 40, with higher scores indicating higher level of self-esteem.
Measured: 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)
The Paradox of Self-Stigma scale (PaSS-24), a short French-language scale measuring self-stigma and its three related construct of stereotype endorsement, righteous anger and non-disclosure. It includes 24 items rated on a five-point Likert scale ranging between 1="strongly disagree" and 5="strongly agree". The three sub-scores are used in the study.
Measured: 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)
The French validated version of the Beck Hopelessness Scale (BHS), an 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. BHS total score can range between 0 and 20, with higher scores reflecting higher levels of hopelessness.
Measured: 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
The French validated version of the WHOQOL-BREF, a scale including 26 Likert type items, measuring quality of life in four domains: physical health, psychological health, social relationships and environment. Its total score is used in the study.
Measured: 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)
The French validated version of the International Trauma Questionnaire (ITQ), a scale to assess Post Traumatic Stress Disorder (PTSD) and Complex Post Traumatic Stress Disorder (C-PTSD) symptoms among adults. The inventory includes 18 items: six to assess the PTSD, six to assess the Disorders in Self Organisation (DSO), and six to assess functional impairment in several important areas of life. Respondents are required to indicate, on a five-point scale from 0="not at all" to 4="extremely", how much each symptom has bothered them in the past month. A total score, ranging between 0 and 24, can be calculated for the PTSD and DSO subscale. A C-PTSD score, ranging between 0 and 48, can also be calculated by adding the PTSD and DSO subscales. Both the PTSD and the C-PTSD total scores will be used in the study.
Measured: 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)
The Coercion Ladder (CL), a single-item 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: 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
The Index of fairness and the Index of effectiveness, two self-administered inventories which assess if participants perceived the experienced treatment pressures as fair and effective. The indices include four items each, rated on a five-point Likert scale from 1="strongly disagree" to 5="strongly agree". The two indices total scores are used in the study. Higher scores indicate higher perceived fairness and effectiveness.
Measured: 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
The Satisfaction with hospital care questionnaire, a six-item tool developed by the Swiss National Association for Quality Development in hospitals and clinics (ANQ), assessing patients' satisfaction about quality of treatment, information and communication, medication, patient's implication and discharge preparation, on a five-point Likert scale. The total score of global satisfaction is used in the study. Higher score corresponds to higher satisfaction. Moreover, the ANQ questionnaire includes one-item subscale on five-point assessing répondeurs' self-reported health. This subscale is also used in the study.
Measured: 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
The Brief INSPIRE scale, a service user-rated measure assessing perceived staff support for personal recovery. The Brief INSPIRE consists of five items, one for each personal recovery 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 staff in each domain of their personal recovery. A total score between 0 and 100 can be computed, with higher scores indicating higher perceived support.
Measured: Post-intervention, up to 1 month post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Apr 2024
- Primary completion31 Oct 2024
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Morandi, University of Lausanne Hospitals
- Investigators
- Charles Bonsack, Study chair, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320457
- Sponsor's protocol ID
- 2024-00095
- Acronym
- CARP
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06320457
- Acronym / sponsor ID
- CARP / 2024-00095
- Keywords
- coercion, involuntary admission, personal recovery, case management, psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Brief case management interventionBrief case management intervention group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have been involuntarily admitted by a medical doctor
- To be aged between 18 and 65 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief case management interventionThe 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 | Other | Intervention group |
Primary outcome
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.
11 secondary outcomes
Recovery Assessment Scale (RAS)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post-intervention, up to 1 month post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Bonsack study chair
Centre hospitalier universitaire vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief case management intervention in people with Psychiatric Disorder and Involuntary Psychiatric Hospitalization, run by University of Lausanne Hospitals 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: From start of study recruitment through study recruitment completion, on average 6 months). The study lists 8 primary outcomes in all. 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 4 Apr 2025.