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SchizophreniaDAiPNCT03630822

Multicenter, Randomized, Comparative and Prospective Study Evaluating the Impact on the Care Path of an Editorial Program Accompanied by Advance Directives in Psychiatry (DAP) for People Suffering From Schizophrenia, Bipolar I Disorder or Schizoaffective Disorder

A study testing Psychiatric Advanced Directive in people with Schizophrenia and Bipolar I Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia, Bipolar I Disorder
What is being tested?
Psychiatric Advanced Directive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
1 siteFrance
Study dates
2 Jan 2019to 2 Jan 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • over 18 years old;
  • diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder
  • receiving ambulatory care by a treating psychiatrist, investigator
  • having been hospitalized under duress at least once during the year preceding the inclusion
  • being in decision-making jurisdiction
  • can be under curator
  • agreeing to participate in the study and with informed consent signed by the subject, as well as by the legal representative in the case of a person under guardianship.

Who cannot join

  • less than 18 years old;
  • participating in another study simultaneously
  • in situations of decision-making incompetence
  • not able to read and write
  • refusing to participate in the study, or the legal representative refusing to participate in the study in the case of a person under guardianship.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

Other trials in France

About this study

Official title: Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial

Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power to act in the evolution of these disorders, new strategies to better reflect the views of people have been developed.

Among these, the drafting of Advanced Directives in Psychiatric (ADP), allows people with mental disorders to write while their decision-making skills are restored care instructions in case of decompensation.

Read more

It is a tool of "advanced therapeutic education" and early prevention of relapses.

It is hypothesized that the implementation of drafting accompanied by advance directives to people with severe psychiatric disorders decreases in the short term the number of forced hospitalization care pathway of these people, compared to the subjects having not benefited from this device.

This research will take the form of a randomized controlled trial on 3 sites. The "quantitative" evaluation component of results and processes will be completed with a qualitative anthropological and socio-political evaluation component documenting the trajectories of individuals and the implementation of the program, as well as a "participatory research" component aimed at a dialogue between users, researchers and professionals.

The patient who is a beneficiary of the "Advanced Directives in Psychiatric" program will be encouraged to complete the " Advanced Directives in Psychiatric" document and will receive support in drafting them. The non-beneficiary patient of the program will follow up with his psychiatrist unchanged.

The experimental design of the quantitative component is based on an experimental, randomized, prospective, controlled, parallel study, comparing two groups of subjects with severe psychiatric disorders.

This research will assess the effectiveness, efficiency and impact of the " Advanced Directives in Psychiatric" program compared to conventional psychiatric care alone.

Ultimately, the objective of describing the effects of the program on health organizations and on the representations and practices of professionals, caregivers and users is at the service of a better understanding of the conditions of possibility of the generalization of this experimentation.

Being tested
Psychiatric Advanced Directive, Standard care
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychiatric Advanced DirectiveBehavioural

    The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.

  • Standard careBehavioural

    standardized maintenance with the patient

Study groups in NCT03630822
Study groupRoleWhat they receive
beneficiary of the advance directive programExperimentalNot described
Receives: Behavioral: Psychiatric Advanced Directive
beneficiary of standard SupportActive comparatorNot described
Receives: Behavioral: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients with compulsory admission

    Evaluation of the hospitalization rate by comparing the two groups

    Measured: 12 months

Secondary outcomes (11)

  1. Evaluation of patient recovery rates

    The rate is assessed by the Recovery Assessment Scale (RAS)

    Measured: 12 months

  2. Evaluation of the empowerment rate

    The rate is assessed by the Empowerment Scale (ES)

    Measured: 12 months

  3. Measuring the health-related quality of life of patients

    Health-related quality of life is measured using a specific scale: the S-QOL. It is a self-reported instrument of 41 items that assesses the quality of life in patients with schizophrenia

    Measured: 12 months

  4. Measuring mental health symptoms of patients

    Mental health symptoms are measured by Modified Colorado Symptom Index (MCSI)

    Measured: 12 months

  5. Evaluation of the therapeutic alliance between the patient and his psychiatrist

    The therapeutic alliance between the patient and his psychiatrist is assessed by the 4-Point Alliance Self Report (4-PAS) questionnaire

    Measured: 12 months

  6. Measuring Disease Awareness

    Disease Awareness is assessed by the évaluée par l'échelle SUMD (Scale to Assess Unawareness in Mental Disorder

    Measured: 12 months

  7. Evaluation of the severity of the psychiatric disorder by the psychiatrist

    The severity of the psychiatric disorder is assessed by the Clinical Global Impression (ICG) scale

    Measured: 12 months

  8. Medico-economic analysis (cost-utility)

    Number of inpatient

    Measured: 12 months

  9. Medico-economic analysis (cost-utility)

    Number of emergency department visits

    Measured: 12 months

  10. Medico-economic analysis (cost-utility)

    Number of outpatient visits

    Measured: 12 months

  11. Medico-economic analysis (cost-utility)

    Loss of productivity

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start2 Jan 2019
  3. Primary completion10 May 2021
  4. Study completion2 Jan 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03630822
Sponsor's protocol ID
2018-04
Other IDs
2018-A00146-49
Acronym
DAiP
Status last verified
Mar 2022
First submitted
10 Aug 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desvignes S, Boucekine M, Loubiere S, Leclerc L, Auquier P, Tinland A. Validation of a French version of the empowerment scale for mental health service users. BMC Psychiatry. 2025 Mar 6;25(1):207. doi: 10.1186/s12888-025-06554-4.

    PubMed 40050829

  • Tinland A, Loubiere S, Mougeot F, Jouet E, Pontier M, Baumstarck K, Loundou A, Franck N, Lancon C, Auquier P; DAiP Group. Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Aug 1;79(8):752-759. doi: 10.1001/jamapsychiatry.2022.1627.

    PubMed 35662314

  • Tinland A, Leclerc L, Loubiere S, Mougeot F, Greacen T, Pontier M, Franck N, Lancon C, Boucekine M, Auquier P. Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study. BMC Psychiatry. 2019 Dec 27;19(1):422. doi: 10.1186/s12888-019-2416-9.

    PubMed 31881954

Questions about this trial

What is this clinical trial studying?

A study testing Psychiatric Advanced Directive in people with Schizophrenia and Bipolar I Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site 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 7 inclusion and 5 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 31 Mar 2022. 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 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?

Rate of patients with compulsory admission (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630822, which also lists 3 linked publications.

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 31 Mar 2022.

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