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Joint Crisis Plan Effectiveness in Preventing Relapses in Schizophrenia and Schizoaffective Disorder

Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627716
Acronym
SOS
Enrollment
124
Registered
2015-12-11
Start date
2014-12-05
Completion date
2016-03-10
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Psychiatric advanced directives, Joint crisis plan, Schizophrenia, Primary care

Brief 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. 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 : 1. the cumulative length of hospitalisations (in days) in the two years following the development of the SOS plan 2. the type of hospitalisation (voluntary or compulsory) 3. the number of hospitalisations for a given subject 4. the number of crisis situations that may require the use of the SOS Plan 5. the clinical condition of the patient 6. the patient with the most responses to the SOS Plan in socio-demographic terms 7. the patient satisfaction in using the SOS Plan 8. the decisional autonomy during treatment 9. the quality of the therapeutic alliance 10. the length of the meeting to develop the SOS Plan 11. the quality of life 12. the medico-economic impact EXECUTION OF PRACTICAL RESEARCH : 1. 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. 2. 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

Interventions

PROCEDURESOS 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.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Refusal to participate in the study * Unable to give his or her written consent * Patients detained * Pregnant or lactating women

Design outcomes

Primary

MeasureTime frameDescription
incidence of the first psychiatric hospitalisation18 monthsthe incidence of the first psychiatric hospitalisation within 18 months following inclusion

Secondary

MeasureTime frameDescription
types of psychiatric hospitalisations2 yearsthe types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)
number of hospitalisations2 yearsthe number of hospitalisations for each subject
number of emergency psychiatric consultations2 yearsthe number of emergency psychiatric consultations
clinical assessment by the PANSS scaleevery 6 months during 2 yearsPANSS score (intensity and qualitative aspects of the clinical situation)
patient satisfactionevery 6 months during 2 yearsscore at a numeric scale of patient satisfaction
cumulative time in days of psychiatric hospitalisations2 yearsthe cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion
Working Alliance Inventoryevery 6 months during 2 yearsthe working alliance assessment
length of the meeting to develop the SOS Planevery 6 months during 2 yearsthe length of the meeting to develop the SOS Plan in minutes
SF-36 quality of lifeevery 6 months during 2 yearsquality of life assessment by the SF-36
medical costevery 6 months during 2 yearsnumbers of hospitalisations, of consultations, drugs consummation
Autonomy Preference Indexevery 6 months during 2 yearsdecision making-autonomy assessment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026