Psychosis; EpisodePLAN-e-PSYNCT04657380
A Mobile Application to Improve Case-management and Patient's Functioning in First Episode Psychosis
A study testing PLAN-e-PSY mobile application in people with Psychosis; Episode, run by Hôpital le Vinatier at 1 site in France.
Trial summary
First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of with progress to a psychotic disorder. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychosis; Episode
- What is being tested?
- PLAN-e-PSY mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2022to 4 Jan 2025
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged between 18 and 30 years old enrolled in a specialised FEP service for a first psychotic episode, defined as follows:
- Presence of daily psychotic symptoms for more than a week that have been characterised at the clinical examination by a psychiatrist, Initiation of antipsychotic treatment for less than 6 months, A diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or brief psychotic disorder established according to DSM-5 criteria.
- Mastery of the French language (read and spoken)
- Owning a smartphone
- Adult patients who have given written consent
Who cannot join
- Patients in psychiatric intensive care units because of severe agitation/disorganisation.
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Ch Le Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678
HAESEBAERT FREDERIC, PH, 0033437914922, frederic.haesebaert@ch-le-vinatier.fr
Lydie SARTELET, 0033437915531, lydie.sartelet@ch-le-vinatier.fr
About this study
Official title: A Mobile Application to Improve Case-management and Patient's Functioning in First Episode Psychosis : an Open-label, Multicentre, Superiority, Randomised Controlled Trial Study
First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of with progress to a psychotic disorder.
The early stages of psychotic disorders, from the first full blown symptoms to the next two to five years, represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.
Read more
Early intervention programmes involve multi-disciplinary teams, including a care coordination function, embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up.
Engagement in the care process is fragile in psychotic disorders, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a "recovery oriented" approach, to foster the feeling of commitment of patients in their care process.
The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department (FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.
User-centred design methods including identification of users and an inventory of their needs, prototyping with rapid iterations, is a simplification of the procedure and exploitation of existing constraints to increase the rate of use. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.
Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices.
The originality of our project is built up on two pillars :
- the use of a a mobile monitoring application, which will be used jointly by patients and case-managers,
- the methodological innovation also lies in the collaborative and patient-centred design of the application The originality of our project concerns on the one hand the intervention, an application mobile follow-up, which will be used jointly by patients and case managers. The innovative character also lies at the methodological level in the collaborative and patient-centered design of the application ('user-centered design' approach).
Read the detailed description
Psychosis and early intervention First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of wish progress to a psychotic disorder.
From the first full blown symptoms to the next two to five years, the early stages of psychotic disorders represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it Is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.
A pejorative evolution can be avoided by the establishment of "early intervention in psychosis" (EIP), constituted by a set of integrated supports that allow to reduce the symptoms of the disease, promote recovery, foster better social and professional functioning. Moreover, it has recently been shown that EIP reduces general mortality including by suicide in the population monitored. In addition, medico-economic benefits of early intervention have been demonstrated in terms of direct and indirect costs. Thus, this intervention model is currently considered as the reference care in early intervention.
Case management: a strategy to promote recovery in early psychosis Early intervention programmes involve multi-disciplinary teams, including a care coordination function embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up. Those missions are broken down into several actions, the content is adapted to the duration of care according to the severity of the disorder and the level of remission.
Case management require essential qualities/ skills such as: accessibility, flexibility, optimism and competence. This model of intervention is effective for patients with FEP and is now considered as a "standard" of care for this population Psychosis and engagement in healthcare: a critical situation In psychotic disorders, the engagement in the care process is fragile, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. Between 20 and 40% of patients with FEP disengage with care despite significant therapeutic needs. The relapse rate one year after stopping treatment ranges from 28% ( to 67% after a first episode of psychosis. Due to the complexity of factors involved in the engagement, it remains endlessly threatened despite better engagement rates in dedicated FEP services compared to "traditional/usual" care, of which the most important is the perception that the service is not adapted to their needs. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a recovery-oriented approach, to foster the feeling of commitment of patients in their care process.
Mobile applications in mental health: a promising way to promote engagement in FEP services The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. Mobile mental health applications offer many possibilities: an appointment management, an information on the illness, a monitoring of symptoms, a deployment of psychotherapeutic techniques, etc… Mobile applications appear now as promising tools not only for better engagement in care, but also for better self-management capabilities and better coordination of resources. Recent data show an increase in the rate of smartphone equipment in the population of patients with psychosis (over 80%). Qualitative studies in this population show that this type of tools is in great demand, in particular to promote the bound between the patient and services and strengthen the self-management capacities.
Many of the recently implemented applications are aimed for in-patients with short evaluation periods, which does not allow longer term usage data. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.
Despite the fact that some applications specifically designed for FEP patients exist and have shown promising results, none have been developed in French and evaluated in French healthcare system. Moreover, anchoring the design of the application in recovery theory would make it possible to better align the actions resulting from the use of the application with the patient's needs.
User-centred design: a method suitable to build "recovery-oriented" tools User-centred design methods, initially developed for human-computer interactions are generally broken down into several phases, including identification of users and an inventory of their needs, prototyping with rapid iterations (i.e. a trial-and-error type strategy allowing rapid feedback from users), simplification of the procedure and exploitation of existing constraints to increase the rate of use. These approaches are particularly developed in the field of mobile application design because they make it possible to create a product that is closer to the concerns of the target person and is so particularly suitable for a "recovery-oriented" approach. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.
Research hypothesis Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices
- Conditions
- Psychosis; Episode
- Being tested
- PLAN-e-PSY mobile application, Control Group
- Keywords
- FEP, case management, smartphone application, User-centered design, Mixed method, RCT
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAN-e-PSY mobile applicationBehavioural
The full version of the application to be evaluated will result from the process of co-design phase of the intervention based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers, to define the content and form of the smartphone application during co-building workshops
Control GroupBehavioural
The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network
| Study group | Role | What they receive |
|---|---|---|
| Usual case management practices | Active comparator | The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network of caring and non-caregiving professionals, working together with a view to the successful recovery of the patient. The patient and his or her family are at the center of care and receive proposals for psychoeducation and support throughout the different phases of the illness. This is concomitant with a regular evaluation of patients in order to update the care offer according to their clinical needs. Receives: Behavioral: Control Group |
| Mobile case-management application | Experimental | The intervention tested will be a mobile application used during consultations involving the patient and the case manager to define care objectives. The mobile application to be evaluated will result from the process of a co-design phase based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers. These stakeholders will define the content and form of the smartphone application during co-building workshops.
The main purpose of the final application will be to assist in the definition of patients' goals using an approach rooted in recovery theory, with the monitoring of goal achievement in three phases : 1) defining priorities for the patients, through a recovery oriented discussion with the patient and the case manager 2) Setting the concrete objectives and list concrete actions tho achieve them 3) evaluating the achievements. Receives: Behavioral: PLAN-e-PSY mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal and Social Performance (PSP) scale
Variation in the patient's functioning score measured by the "Personal and Social Performance (PSP)" scale, informed by a psychiatrist, trained in the use of the scale, not directly involved in the patient's follow-up and blinded to the patient's randomisation group.
This hetero-evaluative scale, available in French, assesses functioning in a single score that takes into account four domains: productive social activities (work/study), social network, personal care, and disruptive or aggressive behaviour. The integrative score ranges from 0 to 100, with higher scores reflecting better functioning.
Functioning corresponds to an individual's capacity to assume his or her social role, in the domestic, professional or school, emotional, family and friendship spheres. This is the final objective of case-managed FEPs.
Measured: Between inclusion and 12 months
Secondary outcomes (15)
Evolution of the Personal and Social Performance Scale PSP
Evolution of the functioning score measured by the PSP in the patient. The outcome will be the evolution of the PSP score compared in both groups. Total score range: 1 to 100, higher score indicates better functioning.
Measured: Between inclusion and 6 months and between inclusion and 12 months
Therapeutic alliance
Therapeutic alliance as measured by the working alliance inventory (WAI) ): total score range: 36 to 252, higher score indicates better working alliance, patient scale and caregiver scale (case-manager). The outcome will be the evolution of the WAI score compared in both groups.
Measured: Between inclusion and 6 months and between inclusion and 12 months
Adherence to drug treatment
Adherence to drug treatment as measured by the Medical Adherence Rating Scale (MARS) score total score range: 0 to 10, higher score indicates better medical adherence. The assessment criterion will be the evolution of the MARS score compared in both groups.
Measured: Between inclusion and 6 months and between inclusion and 12 months
Psychotic symptomatology
Psychotic symptomatology assessed by the Positive and Negative Symptoms Scale (PANSS) : total score range: 30 to 210, higher score indicates worse symptomatology. This questionnaire hetero assessment gives 3 scores, positive symptoms, negative symptoms and general psychopathology. The outcome will be the evolution of the PANSS score compared in both groups
Measured: Between inclusion and 6 months and between inclusion and 12 months
Recovery
Recovery assessed by the Stages of Recovery Instrument (STORI) the scale is composed of 50 items, grouped in 10 categories. Each categories represents one of the four process components of recovery: hope; identity; meaning; responsibility. The assessment criterion will be the evolution of the STORI score compared in both groups
Measured: Between inclusion and 6 months and between inclusion and 12 months
Life self-report scale
Quality of life assessed by the Schizophrenia Quality of Life self-report scale - 18 items (S-QoL-18) : the scale is composed of 18 items regrouped in 8 dimensions ranging from 0 to 100. A total score is also calculated (range 0-100). Lower scores indicate lower quality of life. The outcome will be the evolution of the S-QoL-18 score compared in both groups
Measured: Between inclusion and 6 months and between inclusion and 12 months
Level of empowerment
Level of empowerment assessed by the Patient Activation Measure (PAM) self-questionnaire (total score range: 0 to 100, higher score indicates higher activation level). The evaluation criterion will be the evolution of the PAM score compared in both groups.
Measured: Between inclusion and 6 months and between inclusion and 12 months
Patient engagement in care
Patient engagement in care assessed by the Service Engagement Scale (SES) translated into French (: total score range: 0 to 42. Higher scores reflected clients' greater levels of difficulty engaging with services). The evaluation criterion will be the evolution of the SES score compared in both groups.
Measured: Between inclusion and 6 months and between inclusion and 12 months
Patient satisfaction with case-management
Patient satisfaction with case-management assessed by a self-administered questionnaire constructed in the study using a visual analogue scale (VAS). The evaluation criterion will be the evolution of the VAS score compared in the centre and both groups
Measured: Between inclusion and 6 months and between inclusion and 12 months
Hospitalisation for relapse of psychosis
Evaluation in the patient in both groups of the number of days of hospitalisation for relapse of psychosis, collected at follow-up.
Measured: Over12 months
Acceptability and appropriation of the PLAN-e-PSY application
The acceptability and appropriation of the application (intervention group) by patients (strengths and limitations of the application) and the case-manager (strengths and limitations of the application, perceived change in practices, commitment) assessed during the semi-structured interviews
Measured: At 12 months
Fidelity of use of the PLAN-e-PSY application
Fidelity of use by the case manager and patients of the different parts of the application in relation to the defined procedures. These elements will be collected from the application's internal monitoring data
Measured: Over12 months
Case manager effective use of the PLAN-e-PSY application
Proportion of case manager consultations during which the application was not used. These elements will be collected from the application's internal monitoring data
Measured: At 12 months
Patient effective use of the PLAN-e-PSY application
Proportion of patients who stopped using the application. These elements will be collected from the application's internal monitoring data
Measured: At 12 months
Time of effective use of the PLAN-e-PSY application
Time of effective use by the case manager and patients of the application. These elements will be collected from the application's internal monitoring data
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start4 Dec 2022 (estimated)
- Primary completion4 Jan 2024 (estimated)
- Study completion4 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychosis; EpisodeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their carers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic HAESEBAERT, PH, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657380
- Sponsor's protocol ID
- PHRCI19FH
- Acronym
- PLAN-e-PSY
- Status last verified
- Mar 2022
- First submitted
- 1 Dec 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haesebaert F, El Oussoul S, Pavard A, Fabre D, Cellard C, Magaud L, Subtil F, Damiolini E, Fakra E, Haesebaert J. PLAN-e-PSY, a mobile application to improve case management and patient's functioning in first episode psychosis: protocol for an open-label, multicentre, superiority, randomised controlled trial. BMJ Open. 2021 Sep 14;11(9):e050433. doi: 10.1136/bmjopen-2021-050433.
PubMed 34521670
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application to Improve Case-management and Patient's Functioning in First Episode Psychosis : an Open-label, Multicentre, Superiority, Randomised Controlled Trial Study
- ClinicalTrials.gov ID
- NCT04657380
- Acronym / sponsor ID
- PLAN-e-PSY / PHRCI19FH
- Conditions
- Psychosis; Episode
- Keywords
- FEP, case management, smartphone application, User-centered design, Mixed method, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 4 Dec 2022 (estimated)
- Primary completion
- 4 Jan 2024 (estimated)
- Study completion
- 4 Jan 2025 (estimated)
- First posted
- 8 Dec 2020 (actual)
- 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.
First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of with progress to a psychotic disorder.
The early stages of psychotic disorders, from the first full blown symptoms to the next two to five years, represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.
Early intervention programmes involve multi-disciplinary teams, including a care coordination function, embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up.
Engagement in the care process is fragile in psychotic disorders, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a "recovery oriented" approach, to foster the feeling of commitment of patients in their care process.
The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department (FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.
User-centred design methods including identification of users and an inventory of their needs, prototyping with rapid iterations, is a simplification of the procedure and exploitation of existing constraints to increase the rate of use. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.
Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices.
The originality of our project is built up on two pillars :
- the use of a a mobile monitoring application, which will be used jointly by patients and case-managers,
- the methodological innovation also lies in the collaborative and patient-centred design of the application The originality of our project concerns on the one hand the intervention, an application mobile follow-up, which will be used jointly by patients and case managers. The innovative character also lies at the methodological level in the collaborative and patient-centered design of the application ('user-centered design' approach).
Detailed description
Psychosis and early intervention First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of wish progress to a psychotic disorder.
From the first full blown symptoms to the next two to five years, the early stages of psychotic disorders represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it Is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.
A pejorative evolution can be avoided by the establishment of "early intervention in psychosis" (EIP), constituted by a set of integrated supports that allow to reduce the symptoms of the disease, promote recovery, foster better social and professional functioning. Moreover, it has recently been shown that EIP reduces general mortality including by suicide in the population monitored. In addition, medico-economic benefits of early intervention have been demonstrated in terms of direct and indirect costs. Thus, this intervention model is currently considered as the reference care in early intervention.
Case management: a strategy to promote recovery in early psychosis Early intervention programmes involve multi-disciplinary teams, including a care coordination function embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up. Those missions are broken down into several actions, the content is adapted to the duration of care according to the severity of the disorder and the level of remission.
Case management require essential qualities/ skills such as: accessibility, flexibility, optimism and competence. This model of intervention is effective for patients with FEP and is now considered as a "standard" of care for this population Psychosis and engagement in healthcare: a critical situation In psychotic disorders, the engagement in the care process is fragile, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. Between 20 and 40% of patients with FEP disengage with care despite significant therapeutic needs. The relapse rate one year after stopping treatment ranges from 28% ( to 67% after a first episode of psychosis. Due to the complexity of factors involved in the engagement, it remains endlessly threatened despite better engagement rates in dedicated FEP services compared to "traditional/usual" care, of which the most important is the perception that the service is not adapted to their needs. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a recovery-oriented approach, to foster the feeling of commitment of patients in their care process.
Mobile applications in mental health: a promising way to promote engagement in FEP services The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. Mobile mental health applications offer many possibilities: an appointment management, an information on the illness, a monitoring of symptoms, a deployment of psychotherapeutic techniques, etc… Mobile applications appear now as promising tools not only for better engagement in care, but also for better self-management capabilities and better coordination of resources. Recent data show an increase in the rate of smartphone equipment in the population of patients with psychosis (over 80%). Qualitative studies in this population show that this type of tools is in great demand, in particular to promote the bound between the patient and services and strengthen the self-management capacities.
Many of the recently implemented applications are aimed for in-patients with short evaluation periods, which does not allow longer term usage data. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.
Despite the fact that some applications specifically designed for FEP patients exist and have shown promising results, none have been developed in French and evaluated in French healthcare system. Moreover, anchoring the design of the application in recovery theory would make it possible to better align the actions resulting from the use of the application with the patient's needs.
User-centred design: a method suitable to build "recovery-oriented" tools User-centred design methods, initially developed for human-computer interactions are generally broken down into several phases, including identification of users and an inventory of their needs, prototyping with rapid iterations (i.e. a trial-and-error type strategy allowing rapid feedback from users), simplification of the procedure and exploitation of existing constraints to increase the rate of use. These approaches are particularly developed in the field of mobile application design because they make it possible to create a product that is closer to the concerns of the target person and is so particularly suitable for a "recovery-oriented" approach. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.
Research hypothesis Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their carers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices
| Arm | Type | Receives |
|---|---|---|
| Usual case management practices | Active comparator | Behavioral: Control GroupThe first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network of caring and non-caregiving professionals, working together with a view to the successful recovery of the patient. The patient and his or her family are at the center of care and receive proposals for psychoeducation and support throughout the different phases of the illness. This is concomitant with a regular evaluation of patients in order to update the care offer according to their clinical needs. |
| Mobile case-management application | Experimental | Behavioral: PLAN-e-PSY mobile applicationThe intervention tested will be a mobile application used during consultations involving the patient and the case manager to define care objectives. The mobile application to be evaluated will result from the process of a co-design phase based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers. These stakeholders will define the content and form of the smartphone application during co-building workshops. The main purpose of the final application will be to assist in the definition of patients' goals using an approach rooted in recovery theory, with the monitoring of goal achievement in three phases : 1) defining priorities for the patients, through a recovery oriented discussion with the patient and the case manager 2) Setting the concrete objectives and list concrete actions tho achieve them 3) evaluating the achievements. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 30 years old enrolled in a specialised FEP service for a first psychotic episode, defined as follows:
- Presence of daily psychotic symptoms for more than a week that have been characterised at the clinical examination by a psychiatrist, Initiation of antipsychotic treatment for less than 6 months, A diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or brief psychotic disorder established according to DSM-5 criteria.
- Mastery of the French language (read and spoken)
- Owning a smartphone
- Adult patients who have given written consent
Key exclusion criteria (2 listed)
- Patients in psychiatric intensive care units because of severe agitation/disorganisation.
- Patients under guardianship
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 |
|---|---|---|
| PLAN-e-PSY mobile applicationThe full version of the application to be evaluated will result from the process of co-design phase of the intervention based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers, to define the content and form of the smartphone application during co-building workshops | Behavioural | Mobile case-management application |
| Control GroupThe first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network | Behavioural | Usual case management practices |
Primary outcome
Personal and Social Performance (PSP) scale
Time frame: Between inclusion and 12 months
Variation in the patient's functioning score measured by the "Personal and Social Performance (PSP)" scale, informed by a psychiatrist, trained in the use of the scale, not directly involved in the patient's follow-up and blinded to the patient's randomisation group. This hetero-evaluative scale, available in French, assesses functioning in a single score that takes into account four domains: productive social activities (work/study), social network, personal care, and disruptive or aggressive behaviour. The integrative score ranges from 0 to 100, with higher scores reflecting better functioning. Functioning corresponds to an individual's capacity to assume his or her social role, in the domestic, professional or school, emotional, family and friendship spheres. This is the final objective of case-managed FEPs.
15 secondary outcomes
Evolution of the Personal and Social Performance Scale PSP
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Therapeutic alliance
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Adherence to drug treatment
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Psychotic symptomatology
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Recovery
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Life self-report scale
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Level of empowerment
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Patient engagement in care
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Patient satisfaction with case-management
Time frame: Between inclusion and 6 months and between inclusion and 12 months
Hospitalisation for relapse of psychosis
Time frame: Over12 months
Acceptability and appropriation of the PLAN-e-PSY application
Time frame: At 12 months
Fidelity of use of the PLAN-e-PSY application
Time frame: Over12 months
Case manager effective use of the PLAN-e-PSY application
Time frame: At 12 months
Patient effective use of the PLAN-e-PSY application
Time frame: At 12 months
Time of effective use of the PLAN-e-PSY application
Time frame: Over 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 34521670Haesebaert F, El Oussoul S, Pavard A, Fabre D, Cellard C, Magaud L, Subtil F, Damiolini E, Fakra E, Haesebaert J. PLAN-e-PSY, a mobile application to improve case management and patient's functioning in first episode psychosis: protocol for an open-label, multicentre, superiority, randomised controlled trial. BMJ Open. 2021 Sep 14;11(9):e050433. doi: 10.1136/bmjopen-2021-050433.
- Individual participant dataSharing planned: No
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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.
Frederic HAESEBAERT, PH principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAN-e-PSY mobile application in people with Psychosis; Episode, run by Hôpital le Vinatier 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederic HAESEBAERT, Ph (00 (33) 437 915 565, frederic.haesebaert@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal and Social Performance (PSP) scale (time frame: Between inclusion and 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 NCT04657380, which also lists 1 linked publication.
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 24 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.