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CompletedNCT06320457CARPUpdated Apr 4, 2025

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

An interventional study of Brief case management intervention in Psychiatric Disorder and Involuntary Psychiatric Hospitalization, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).
02

Conditions studied

  • Psychiatric Disorder
  • Involuntary Psychiatric Hospitalization

Keywords

  • coercion
  • involuntary admission
  • personal recovery
  • case management
  • psychiatry
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 26 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Intervention group

    Brief case management intervention group

    Other: Brief case management intervention

Interventions

  • OtherBrief case management intervention

    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

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

    Time frame: Post-intervention, up to 1 month post hospital discharge

  4. 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

    Time frame: Post-intervention, up to 1 month post hospital discharge

  5. Missing data rates

    Percentage of missing data

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

  6. 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

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

  7. 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

    Time frame: Post-intervention, up to 1 month post hospital discharge

  8. 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.

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

Secondary outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. 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.

    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)

  6. 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.

    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)

  7. 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.

    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)

  8. 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".

    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)

  9. 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.

    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)

  10. 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.

    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)

  11. 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.

    Time frame: Post-intervention, up to 1 month post hospital discharge

07

Study locations

1 site
  • Lausanne University Hospital
    Lausanne, Canton of Vaud 1003, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06320457
Lead sponsor
University of Lausanne Hospitals
Responsible party
Stéphane Morandi (Deputy Head of the Community Psychiatry Service, PD & MER, University of Lausanne Hospitals) — Principal investigator
First posted
Mar 20, 2024
Start date
Apr 15, 2024
Primary completion
Oct 31, 2024
Completion
Jan 21, 2025
Last update
Apr 4, 2025

Study contacts

Charles Bonsack
study chair · Centre Hospitalier Universitaire Vaudois, CHUV

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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