Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392139
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-06
Brief Title:
Specialized Healthcare Service for BPD Patients Athens Trial
Sponsor:
Ioannis A Malogiannis
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
A Quasi-experimental Pragmatic Trial Evaluating a Tailored Healthcare Service for Patients With Borderline Personality Disorder Borderline Personality Disorder Athens Study BPDAS
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPDAS
Brief Summary:
A quasi-experimental pragmatic trial was developed to evaluate a specific health-care service for the treatment of biporal personality disorder BPD patientsThe effectiveness and economic evaluation cost-effectiveness and cost-utility of this specific health-care service as it is offered in every-day clinical practice will be assesed The main hypothesis of the particular study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual
Furthermore two additional substudies will be performed The first one is a qualitative study on the experiences of patients and therapists of the specific program as compared to common treatment The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program
Patients will be followed for 2 years
Furthermore two additional substudies will be performed The first one is a qualitative study on the experiences of patients and therapists of the specific program as compared to common treatment The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program
Patients will be followed for 2 years
Detailed Description:
There is a lack of studies evaluating the effectiveness of health care services providing treatment for patients with borderline personality disorder This study is the first to evaluate a psychoanalytically-oriented intervention that is developed specifically for BPD
A quasi-experimental pragmatic trial for the evaluation of a specific health-care service for BPD patients was developed The effectiveness and economic evaluation cost-effectiveness and cost-utility of a special health service for the treatment of BPD patients as it is offered in the every-day clinical practice will be assessed
This health-care service is the Specific Therapy Program for BPD patients of the 1st Psychiatric Clinic of the Medical School of the National and Kapodistrian University of Athens It has provided a wide range of different treatment interventions outpatient inpatient and day care
The main hypothesis of the study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual
Furthermore two additional substudies will be performed The first one regards a qualitative study on the experiences of patients and therapists of the specific program and of the TAU Qualitative data will be collected from interviews andor focus groups This study aims to provide information on the aspects of the specific health care service that are more advantageous for the patients The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program and will be based both on empirical qualitative data
Patients will be followed for 2 years The outcome measures will be assessed at baseline before the assignment of the patient and every 6 months until the completion of the 2nd year follow-up 6 months 1 year 18 months 2 years The assessment of the mediators for the evaluation of the mechanisms of change for the patients of the study will be contacted at baseline and then every year 1 year 2 years An additional follow up assessment will be administered 6 months and 1 year after the completion of the study
A quasi-experimental pragmatic trial for the evaluation of a specific health-care service for BPD patients was developed The effectiveness and economic evaluation cost-effectiveness and cost-utility of a special health service for the treatment of BPD patients as it is offered in the every-day clinical practice will be assessed
This health-care service is the Specific Therapy Program for BPD patients of the 1st Psychiatric Clinic of the Medical School of the National and Kapodistrian University of Athens It has provided a wide range of different treatment interventions outpatient inpatient and day care
The main hypothesis of the study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual
Furthermore two additional substudies will be performed The first one regards a qualitative study on the experiences of patients and therapists of the specific program and of the TAU Qualitative data will be collected from interviews andor focus groups This study aims to provide information on the aspects of the specific health care service that are more advantageous for the patients The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program and will be based both on empirical qualitative data
Patients will be followed for 2 years The outcome measures will be assessed at baseline before the assignment of the patient and every 6 months until the completion of the 2nd year follow-up 6 months 1 year 18 months 2 years The assessment of the mediators for the evaluation of the mechanisms of change for the patients of the study will be contacted at baseline and then every year 1 year 2 years An additional follow up assessment will be administered 6 months and 1 year after the completion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None