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Completed

NCT Number: NCT02627716

Joint Crisis Plan Effectiveness in Preventing Relapses in 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.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Brest, Brest, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOS Plan

Procedure

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.

Other names: Joint Crisis Plan

Primary outcomes

  1. incidence of the first psychiatric hospitalisation

    Time frame: 18 months

    the incidence of the first psychiatric hospitalisation within 18 months following inclusion

Secondary outcomes

  1. cumulative time in days of psychiatric hospitalisations

    Time frame: 2 years

    the cumulative time, in days, of psychiatric hospitalisations in the two years following inclusion

  2. types of psychiatric hospitalisations

    Time frame: 2 years

    the types of psychiatric hospitalisation: voluntary (SL) or compulsory (SDT)

  3. number of hospitalisations

    Time frame: 2 years

    the number of hospitalisations for each subject

  4. number of emergency psychiatric consultations

    Time frame: 2 years

    the number of emergency psychiatric consultations

  5. clinical assessment by the PANSS scale

    Time frame: every 6 months during 2 years

    PANSS score (intensity and qualitative aspects of the clinical situation)

  6. patient satisfaction

    Time frame: every 6 months during 2 years

    score at a numeric scale of patient satisfaction

  7. Autonomy Preference Index

    Time frame: every 6 months during 2 years

    decision making-autonomy assessment

  8. Working Alliance Inventory

    Time frame: every 6 months during 2 years

    the working alliance assessment

  9. length of the meeting to develop the SOS Plan

    Time frame: every 6 months during 2 years

    the length of the meeting to develop the SOS Plan in minutes

  10. SF-36 quality of life

    Time frame: every 6 months during 2 years

    quality of life assessment by the SF-36

  11. medical cost

    Time frame: every 6 months during 2 years

    numbers of hospitalisations, of consultations, drugs consummation

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: SOS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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