NCT03630822: DAiP

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

Completed NA Last updated 31 March 2022

What this trial tests

NA trial testing Psychiatric Advanced Directive in Schizophrenia in 399 participants. Completed in 2 January 2022.

Timeline

2 January 2019

Primary endpoint
10 May 2021

2 January 2022

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	399
Start date	2 January 2019
Primary completion	10 May 2021
Estimated completion	2 January 2022
Sites	1 location across France

Drugs / interventions tested

• Psychiatric Advanced Directive
• Standard care — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Bipolar I Disorder — all drugs for Bipolar I Disorder →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, any sex, with Schizophrenia or Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial.
   Tinland A, Loubière S, Mougeot F, Jouet E, et al · · 2022 · cited 34× · PMID 35662314 · DOI 10.1001/jamapsychiatry.2022.1627
2. Psychiatric advance directives facilitated by peer workers among people with mental illness: economic evaluation of a randomized controlled trial (DAiP study).
   Loubière S, Loundou A, Auquier P, Tinland A. · · 2023 · cited 4× · PMID 37096868 · DOI 10.1017/s2045796023000197
3. Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study.
   Tinland A, Leclerc L, Loubière S, Mougeot F, et al · · 2019 · cited 4× · PMID 31881954 · DOI 10.1186/s12888-019-2416-9
4. Validation of a French version of the empowerment scale for mental health service users.
   Desvignes S, Boucekine M, Loubière S, Leclerc L, et al · · 2025 · PMID 40050829 · DOI 10.1186/s12888-025-06554-4
5. A comparative analysis in monitoring 24-hour urinary copper in Wilson Disease: Sampling on or off treatment?
   Mohr I, Lamade P, Weber C, Leidner VY, et al · · 2024 · DOI 10.21203/rs.3.rs-4797096/v1