Specialized Healthcare Service for BPD Patients: Athens Trial
NCT ID: NCT06392139
Last Updated: 2024-04-30
Study Results
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Basic Information
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RECRUITING
NA
156 participants
INTERVENTIONAL
2022-01-07
2026-06-30
Brief Summary
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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
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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 and/or 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental: Intervention group
The Specific Therapy Program for Personality Disorders at the 1st Psychiatric Clinic, Medical School, National and Kapodistrian University of Athens, Eginition Hospital, established in 1999, offers outpatient, inpatient, and day care services with psychoanalytic interventions tailored for Borderline Personality Disorder. Group psychoanalytic psychotherapy sessions are predominant, supported by research. Patients undergo initial 6-8 months of closely monitored outpatient care, including monthly psychodynamically oriented sessions, psychiatric appointments, and psychological assessments, focusing on crisis management and personalized treatment plans. Subsequently, long-term psychodynamic psychotherapy interventions, often combined with psychiatric treatment, provide sustained therapeutic support.
Specific Therapy Program for Personality Disorders
The program was founded in 1999; since then, it has provided a wide range of different treatment interventions (outpatient, inpatient and day care). The interventions are psychoanalytically oriented and specifically for patients with Borderline Personality Disorder. Most of them are in the form of group psychoanalytic psychotherapy. The program consists of two steps: 1) an initial reception outpatient clinic where patients are followed after the referral to the Program, for a period of 6-8 months. This first step consists of monthly psychodynamically oriented sessions, monthly psychiatric appointments and application of psychological assessment instruments. The intervention focuses on crisis management and construction of the treatment plan for every patient. 2) The second step consists of long-term psychodynamic psychotherapy interventions, in combination with psychiatric treatment when it is is needed.
Treatment As Usual (TAU) Group
The TAU group receives the common practice treatment in the two Specific Outpatient Clinics for BPD patients:
1. The Outpatient Clinic for Borderline Personality Disorder Patients of the 2nd Psychiatric Clinic at the Medical School of National and Kapodistrian University of Athens called Attikon General University Hospital and
2. The Outpatient Clinic for Borderline Personality Disorder Patients of the Psychiatric Clinic of Sismanogleion General Hospital.
Treatment As Usual (TAU) Group
The TAU group receives the common practice treatment in the two Specific Outpatient Clinics for BPD patients:
The Outpatient Clinic for Borderline Personality Disorder Patients of the 2nd Psychiatric Clinic at the Medical School of National and Kapodistrian University of Athens called Attikon General University Hospital and The Outpatient Clinic for Borderline Personality Disorder Patients of the Psychiatric Clinic of Sismanogleion General Hospital.
Treatment As Usual (TAU) The TAU includes the psychiatric management, consultation and pharmacotherapy if needed in the two Specific Outpatient Clinics for BPD patients. TAU provides one thirty minutes session per month. In case of crisis management patients contact their psychiatrist during the working hours, or after that they leave a message on the telephone answering machine and if needed make a visit in the Emergency Department of the Hospital on Duty.
Interventions
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Specific Therapy Program for Personality Disorders
The program was founded in 1999; since then, it has provided a wide range of different treatment interventions (outpatient, inpatient and day care). The interventions are psychoanalytically oriented and specifically for patients with Borderline Personality Disorder. Most of them are in the form of group psychoanalytic psychotherapy. The program consists of two steps: 1) an initial reception outpatient clinic where patients are followed after the referral to the Program, for a period of 6-8 months. This first step consists of monthly psychodynamically oriented sessions, monthly psychiatric appointments and application of psychological assessment instruments. The intervention focuses on crisis management and construction of the treatment plan for every patient. 2) The second step consists of long-term psychodynamic psychotherapy interventions, in combination with psychiatric treatment when it is is needed.
Treatment As Usual (TAU) Group
The TAU group receives the common practice treatment in the two Specific Outpatient Clinics for BPD patients:
The Outpatient Clinic for Borderline Personality Disorder Patients of the 2nd Psychiatric Clinic at the Medical School of National and Kapodistrian University of Athens called Attikon General University Hospital and The Outpatient Clinic for Borderline Personality Disorder Patients of the Psychiatric Clinic of Sismanogleion General Hospital.
Treatment As Usual (TAU) The TAU includes the psychiatric management, consultation and pharmacotherapy if needed in the two Specific Outpatient Clinics for BPD patients. TAU provides one thirty minutes session per month. In case of crisis management patients contact their psychiatrist during the working hours, or after that they leave a message on the telephone answering machine and if needed make a visit in the Emergency Department of the Hospital on Duty.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* willingness to participate in the study.
Exclusion Criteria
* bipolar disorder type I,
* antisocial personality disorder,
* severe substance dependence resulting in severe cognitive restrictions during therapy, needing clinical detoxification,
* IQ below 80,
* organic brain disease,
* poor Greek language skills.
18 Years
55 Years
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
University Mental Health Research Institute, Athens, Greece
OTHER
Sismanogleion General Hospital, 3rd Respiratory Medicine Department
OTHER
Attikon Hospital
OTHER
Ioannis A. Malogiannis
OTHER
Responsible Party
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Ioannis A. Malogiannis
Mr Ioannis A. Malogiannis, Head of the BPD Specific Sector
Locations
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1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital
Athens, Attica, Greece
Outpatient Clinic for Borderline Personality Disorder Patients, 2nd Psychiatric Clinic, Medical School of National Kapodistrian University of Athens: Attikon General University Hospital
Athens, Attica, Greece
Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Ioannis A. Malogiannis, MD
Role: primary
Lily E. Peppou
Role: backup
Panagiotis Aristotelidis, MD
Role: primary
Maria Aspradaki, MD
Role: primary
References
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Vaslamatzis G, Coccossis M, Zervis C, Panagiotopoulou V, Chatziandreou M. A psychoanalytically oriented combined treatment approach for severely disturbed borderline patients: the Athens project. Bull Menninger Clin. 2004 Fall;68(4):337-49. doi: 10.1521/bumc.68.4.337.56640.
Vaslamatzis G, Theodoropoulos P, Vondikaki S, Karamanolaki H, MiliaTsanira M, Gourounti K. Is the residential combined (psychotherapy plus medication) treatment of patients with severe personality disorder effective in terms of suicidality and impulsivity? J Nerv Ment Dis. 2014 Feb;202(2):138-43. doi: 10.1097/NMD.0000000000000083.
E. Layiou-Lignos, L. Anagnostaki, I. Malogiannis & H. Karamanolaki (2021): The psychoanalytic psychotherapy endeavor in the Greek public sector, Psychoanalytic Psychotherapy, DOI: 10.1080/02668734.2021.1898045
Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.
Leibniz Institute for Psychology (ZPID). (2019). Open Test Archive: BPDSI-IV. Borderline Personality Disorder Severity Index (Version IV) - deutsche Fassung. Available at: https://www.testarchiv.eu/en/test/9007150κ
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Wetzelaer P, Farrell J, Evers SM, Jacob GA, Lee CW, Brand O, van Breukelen G, Fassbinder E, Fretwell H, Harper RP, Lavender A, Lockwood G, Malogiannis IA, Schweiger U, Startup H, Stevenson T, Zarbock G, Arntz A. Design of an international multicentre RCT on group schema therapy for borderline personality disorder. BMC Psychiatry. 2014 Nov 18;14:319. doi: 10.1186/s12888-014-0319-3.
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Malogiannis I, Anagnostaki L, Aspradaki M, Aristotelidis P, Karambela K, Amperiadou M, Efthymiou V, Kriezi P, Theodoridou I, Stefanatou P, Konstantakopoulos G, Souliotis K, Peppou LE, Giannoulis E. Borderline personality disorder Athens study: a quasi-experimental pragmatic trial for the assessment of a public, psychodynamic, stepped care service for borderline personality disorder patients. Front Psychiatry. 2025 Jul 1;16:1493265. doi: 10.3389/fpsyt.2025.1493265. eCollection 2025.
Other Identifiers
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No. 404/06-07-2021
Identifier Type: -
Identifier Source: org_study_id