Psychotic DisordersCAMATNCT02873884
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)
An observational study of Psychotic Disorders, run by University Hospital, Caen at 1 site in France.
Trial summary
The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Case-management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Nov 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: First episode psychosis patients
Who may be able to join
- Age between 16 and 30 years
- First episode psychosis diagnosis according to DSM-5 criteria
Who cannot join
- Lees of 16 years or more than 30 years
- Not fulfilling DSM-5 criteria for first episode psychosis
- Any treatment with the psychologist or the psychiatrist of the team
Trial locations and contacts
1 site in 1 country.
Laurent Lecardeur, PhD contact
About this study
The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.
- Conditions
- Psychotic Disorders
- Being tested
- Case-management
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| case-management | Patients will meet the case-manager 5 times per month during 1h30 in community living Receives: Behavioral: Case-management | |
| traditional nursing | Patients will meet the case-manager 2 times per month during 1h00 in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work alliance inventory
Measured: 6 months
Secondary outcomes (3)
Birchwood insight scale
Measured: 6 months
Scale to assess Unawareness of Mental Disorder
Measured: 6 months
Well-being at work scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873884
- Sponsor's protocol ID
- CAMAT
- Acronym
- CAMAT
- Status last verified
- Apr 2019
- First submitted
- 17 Aug 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)
- ClinicalTrials.gov ID
- NCT02873884
- Acronym / sponsor ID
- CAMAT / CAMAT
- Conditions
- Psychotic Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- 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.
The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case-management | – | Behavioral: Case-managementPatients will meet the case-manager 5 times per month during 1h30 in community living |
| traditional nursing | – | –Patients will meet the case-manager 2 times per month during 1h00 in hospital |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- First episode psychosis patients
Key inclusion criteria (2 listed)
- Age between 16 and 30 years
- First episode psychosis diagnosis according to DSM-5 criteria
Key exclusion criteria (3 listed)
- Lees of 16 years or more than 30 years
- Not fulfilling DSM-5 criteria for first episode psychosis
- Any treatment with the psychologist or the psychiatrist of the team
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 |
|---|---|---|
| Case-management | Behavioural | case-management |
Primary outcome
Work alliance inventory
Time frame: 6 months
3 secondary outcomes
Birchwood insight scale
Time frame: 6 months
Scale to assess Unawareness of Mental Disorder
Time frame: 6 months
Well-being at work scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
Laurent Lecardeur, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by University Hospital, Caen 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 2 inclusion and 3 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 22 Apr 2019. 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 Laurent Lecardeur, PhD (lecardeur@cyceron.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work alliance inventory (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2019.