SchizophreniaSOSNCT02627716
Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder
A study testing SOS Plan in people with Schizophrenia, run by University Hospital, Lille at 4 sites in France.
Trial summary
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SOS Plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Dec 2014to 10 Mar 2016
- 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
- Aged between 18 and 65 years
- Diagnosed with schizophrenia or schizoaffective disorder according to criteria specified in DSM
- Psychiatric inpatient or an outpatient with a specialised framework of psychiatric follow-ups
- Patient has been hospitalised at least once in a psychiatric department within the previous 2 years
- Adults under protective measures can be included (guardianship/supervision). Consent will also be sought from the guardian or trusted person.
- Registered for social security
Who cannot join
- Refusal to participate in the study
- Unable to give his or her written consent
- Patients detained
- Pregnant or lactating women
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital, Brest
Brest
University Hospital, Caen
Caen
University Hosiptal, Lille
Lille
Sainte-Anne Hospital, Paris
Paris
About this study
Official title: Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.
The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.
Read more
Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.
Single blind multicentre randomised trial with parallel control groups.
Effectiveness study of a psychiatric care strategy.
Read the detailed description
Single blind multicentre randomised trial with parallel control groups.
2 groups:
- SOS Intervention Group: benefits from the SOS Plan in addition to the usual follow-ups
- "Control" Group: receive no additional intervention (only receive the routine follow-ups)
OBJECTIVES :
- To evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care
- To evaluate :
- the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan
- the type of hospitalisation (voluntary or compulsory)
- the number of hospitalisations for a given subject
- the number of crisis situations that may require the use of the SOS Plan
- the clinical condition of the patient
- the patient with the most responses to the SOS Plan in socio-demographic terms
- the patient satisfaction in using the SOS Plan
- the decisional autonomy during treatment
- the quality of the therapeutic alliance
- the length of the meeting to develop the SOS Plan
- the quality of life
- the medico-economic impact
EXECUTION OF PRACTICAL RESEARCH :
- The inclusion visit will be completed apart from a period of acute psychiatric decompensation, while the patient is capable of consenting to treatment. The inclusion visit will be completed within a hospital department before the patient is finally released from hospitalisation or during an outpatient follow-up. This involves placing the patient on the Positive And Negative Syndrome Scale (PANSS) to ensure that the patient's clinical condition allows him to consent to treatment. A score above 95 excludes the patient. The investigator also outlines the study and schedules visits. The patient then signs both the information letter and informed consent. A urine pregnancy test will be carried out on women of childbearing age.
- Randomisation will be performed by a member of the SOS regional-referral team.
For patients in the SOS Intervention group:
- Preparatory interview with an SOS regional referrer
- SOS Plan development meeting in the presence of the patient, the treating psychiatrist, one or more relatives, and an SOS regional referrer
For patients in the control group: tracking the continuation of psychiatric care according to the standard care terms
3 ) Follow-up visits: for the two groups: 4 visits M6, M12, M18, M24 At each visit: meeting with an independent regional SOS assessor blind to allocation.
For both of the groups:
- Assessment of the clinical condition: placement on the PANSS scale
- Number of psychiatric hospitalisations, types of hospitalisation, duration of hospitalisation since the last visit
- Satisfaction assessment (numeric scale), of the therapeutic alliance (WAI), of decision-making autonomy (API), of quality of life (SF-36)
For the SOS Intervention group:
- Updating the SOS Plan after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks.
- Updating the SOS Plan every 6 months in the absence of hospitalisation
- Conditions
- Schizophrenia
- Being tested
- SOS Plan
- Keywords
- Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOS PlanProcedure or surgery
Also called Joint Crisis Plan
It is a customised procedure that involves a meeting (crisis planning meeting) with the patient, their various medical and social referrers and any other person who they may have desired to invite.
The booklet outlines four avenues to consider:
- Contact details / contact person
- Treatment and current follow-ups
- Medical care in the event of a crisis
- Practical aid in the event of a crisis
Updating the SOS Plan every 6 months in the absence of hospitalisation or after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks.
| Study group | Role | What they receive |
|---|---|---|
| SOS Intervention Group | Experimental | Subjects benefit from the SOS Plan in addition to the usual follow-ups Receives: Procedure: SOS Plan |
| Control Group | No intervention | Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of the first psychiatric hospitalisation
the incidence of the first psychiatric hospitalisation within 18 months following inclusion
Measured: 18 months
Secondary outcomes (11)
cumulative time in days of psychiatric hospitalisations
the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion
Measured: 2 years
types of psychiatric hospitalisations
the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
Measured: 2 years
number of hospitalisations
the number of hospitalisations for each subject
Measured: 2 years
number of emergency psychiatric consultations
the number of emergency psychiatric consultations
Measured: 2 years
clinical assessment by the PANSS scale
PANSS score (intensity and qualitative aspects of the clinical situation)
Measured: every 6 months during 2 years
patient satisfaction
score at a numeric scale of patient satisfaction
Measured: every 6 months during 2 years
Autonomy Preference Index
decision making-autonomy assessment
Measured: every 6 months during 2 years
Working Alliance Inventory
the working alliance assessment
Measured: every 6 months during 2 years
length of the meeting to develop the SOS Plan
the length of the meeting to develop the SOS Plan in minutes
Measured: every 6 months during 2 years
SF-36 quality of life
quality of life assessment by the SF-36
Measured: every 6 months during 2 years
medical cost
numbers of hospitalisations, of consultations, drugs consummation
Measured: every 6 months during 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start5 Dec 2014
- Primary completion10 Mar 2016
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Vaiva, Principal investigator, University Hospiltal Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627716
- Sponsor's protocol ID
- 2014_04
- Other IDs
- 2014-A00911-46
- Acronym
- SOS
- Status last verified
- Sep 2020
- First submitted
- 6 Jul 2015
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02627716
- Acronym / sponsor ID
- SOS / 2014_04
- Conditions
- Schizophrenia
- Keywords
- Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 5 Dec 2014 (actual)
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- 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 Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.
The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.
Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.
Single blind multicentre randomised trial with parallel control groups.
Effectiveness study of a psychiatric care strategy.
Detailed description
Single blind multicentre randomised trial with parallel control groups.
2 groups:
- SOS Intervention Group: benefits from the SOS Plan in addition to the usual follow-ups
- "Control" Group: receive no additional intervention (only receive the routine follow-ups)
OBJECTIVES :
- To evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care
- To evaluate :
- the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan
- the type of hospitalisation (voluntary or compulsory)
- the number of hospitalisations for a given subject
- the number of crisis situations that may require the use of the SOS Plan
- the clinical condition of the patient
- the patient with the most responses to the SOS Plan in socio-demographic terms
- the patient satisfaction in using the SOS Plan
- the decisional autonomy during treatment
- the quality of the therapeutic alliance
- the length of the meeting to develop the SOS Plan
- the quality of life
- the medico-economic impact
EXECUTION OF PRACTICAL RESEARCH :
- The inclusion visit will be completed apart from a period of acute psychiatric decompensation, while the patient is capable of consenting to treatment. The inclusion visit will be completed within a hospital department before the patient is finally released from hospitalisation or during an outpatient follow-up. This involves placing the patient on the Positive And Negative Syndrome Scale (PANSS) to ensure that the patient's clinical condition allows him to consent to treatment. A score above 95 excludes the patient. The investigator also outlines the study and schedules visits. The patient then signs both the information letter and informed consent. A urine pregnancy test will be carried out on women of childbearing age.
- Randomisation will be performed by a member of the SOS regional-referral team.
For patients in the SOS Intervention group:
- Preparatory interview with an SOS regional referrer
- SOS Plan development meeting in the presence of the patient, the treating psychiatrist, one or more relatives, and an SOS regional referrer
For patients in the control group: tracking the continuation of psychiatric care according to the standard care terms
3 ) Follow-up visits: for the two groups: 4 visits M6, M12, M18, M24 At each visit: meeting with an independent regional SOS assessor blind to allocation.
For both of the groups:
- Assessment of the clinical condition: placement on the PANSS scale
- Number of psychiatric hospitalisations, types of hospitalisation, duration of hospitalisation since the last visit
- Satisfaction assessment (numeric scale), of the therapeutic alliance (WAI), of decision-making autonomy (API), of quality of life (SF-36)
For the SOS Intervention group:
- Updating the SOS Plan after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks.
- Updating the SOS Plan every 6 months in the absence of hospitalisation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOS Intervention Group | Experimental | Procedure: SOS PlanSubjects benefit from the SOS Plan in addition to the usual follow-ups |
| Control Group | No intervention | –Subjects receive no additional intervention (tracking the continuation of psychiatric care according to the standard care terms) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years
- Diagnosed with schizophrenia or schizoaffective disorder according to criteria specified in DSM
- Psychiatric inpatient or an outpatient with a specialised framework of psychiatric follow-ups
- Patient has been hospitalised at least once in a psychiatric department within the previous 2 years
- Adults under protective measures can be included (guardianship/supervision). Consent will also be sought from the guardian or trusted person.
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Unable to give his or her written consent
- Patients detained
- Pregnant or lactating women
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 |
|---|---|---|
| SOS PlanAlso: Joint Crisis PlanIt is a customised procedure that involves a meeting (crisis planning meeting) with the patient, their various medical and social referrers and any other person who they may have desired to invite. The booklet outlines four avenues to consider: * Contact details / contact person * Treatment and current follow-ups * Medical care in the event of a crisis * Practical aid in the event of a crisis Updating the SOS Plan every 6 months in the absence of hospitalisation or after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks. | Procedure or surgery | SOS Intervention Group |
Primary outcome
incidence of the first psychiatric hospitalisation
Time frame: 18 months
the incidence of the first psychiatric hospitalisation within 18 months following inclusion
11 secondary outcomes
cumulative time in days of psychiatric hospitalisations
Time frame: 2 years
types of psychiatric hospitalisations
Time frame: 2 years
number of hospitalisations
Time frame: 2 years
number of emergency psychiatric consultations
Time frame: 2 years
clinical assessment by the PANSS scale
Time frame: every 6 months during 2 years
patient satisfaction
Time frame: every 6 months during 2 years
Autonomy Preference Index
Time frame: every 6 months during 2 years
Working Alliance Inventory
Time frame: every 6 months during 2 years
length of the meeting to develop the SOS Plan
Time frame: every 6 months during 2 years
SF-36 quality of life
Time frame: every 6 months during 2 years
medical cost
Time frame: every 6 months during 2 years
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 16 Dec 2025.
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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.
Guillaume Vaiva principal investigator
University Hospiltal Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOS Plan in people with Schizophrenia, run by University Hospital, Lille at 4 sites in France.
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 6 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
incidence of the first psychiatric hospitalisation (time frame: 18 months). 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 16 Dec 2025.