- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873884
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT) (CAMAT)
April 18, 2019 updated by: University Hospital, Caen
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 Overview
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Caen, France
- Recruiting
- CHU de Caen
-
Contact:
- Langeard Martine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 30 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
First episode psychosis patients
Description
Inclusion Criteria:
- Age between 16 and 30 years
- First episode psychosis diagnosis according to DSM-5 criteria
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
case-management
Patients 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Work alliance inventory
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Birchwood insight scale
Time Frame: 6 months
|
6 months
|
Scale to assess Unawareness of Mental Disorder
Time Frame: 6 months
|
6 months
|
Well-being at work scale
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2016
Primary Completion (ANTICIPATED)
November 1, 2019
Study Completion (ANTICIPATED)
November 1, 2019
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 19, 2016
First Posted (ESTIMATE)
August 22, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMAT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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