Specialized Healthcare Service for BPD Patients: Athens Trial

NCT06392139 | Recruiting

• 1 other identifier: No. 404/06-07-2021
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

Brief Summary

A quasi-experimental pragmatic trial was developed to evaluate a specific health-care service for the treatment of biporal personality disorder (BPD) patients.The 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.

Conditions

Other Mental Conditions

Keywords

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

• Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009).

  It is assessed using the Borderline Personality Disorder Severity Index (BPDSI) and the latter is assessed through the number of 1) suicide attempts, 2) life-threatening self-harm behaviors and 3) psychiatric hospital admissions.

  Baseline, 6 months, 1 year, 18 months, 2 years

• Suicide Harm Inventory

  It is an interview designed to ensure accurate collection of data about attempted acts of suicide and incidents of self-harm over a six-month period but does not aim to measure their severity.

  Baseline, 6 months, 1 year, 18 months, 2 years

Secondary Outcomes (10)

• General psychiatric symptoms present at the time of assessment.

  Baseline, 6 months, 1 year, 18 months, 2 years

• Subjective Quality of Life

  Baseline, 6 months, 1 year, 18 months, 2 years

• Distress caused by interpersonal problems

  Baseline, 6 months, 1 year, 18 months, 2 years

• Functional Impairments in fields such as work and household

  Baseline, 6 months, 1 year, 18 months, 2 years

• WHODAS II

  Baseline, 6 months, 2 years

Other Outcomes (3)

• Cost-Effectiveness

  Baseline, 6 months, 1 year, 18 months, 2 years

• ALL 3 MECHANISMS OF CHANGE- RFQ, IPO-GR, DSQ-40

  Baseline, 1 year, 2 years

• ETI - Early Trauma Inventory

  Baseline, 2 years

Study Arms (2)

Experimental: Intervention group

EXPERIMENTAL

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.

Behavioral: Specific Therapy Program for Personality Disorders

Treatment As Usual (TAU) Group

ACTIVE COMPARATOR

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.

Other: Treatment As Usual (TAU) Group

Interventions

Specific Therapy Program for Personality Disorders BEHAVIORAL

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.

Also known as: BPDAS

Experimental: Intervention group

Treatment As Usual (TAU) Group OTHER

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.

Treatment As Usual (TAU) Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• primary diagnosis of BPD (diagnosed with Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD and
• willingness to participate in the study.

You may not qualify if:

• lifetime psychotic disorder (except for a brief psychotic disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, version V, DSM-5, BPD criterion 9,
• 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.

Sponsors & Collaborators

• Ioannis A. Malogiannis: lead
• National and Kapodistrian University of Athens: collaborator
• University Mental Health Research Institute, Athens, Greece: collaborator
• Sismanogleion General Hospital, 3rd Respiratory Medicine Department: collaborator
• Attikon Hospital: collaborator

Study Sites (3)

1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital

Athens, Attica, 11528, Greece

RECRUITING

Outpatient Clinic for Borderline Personality Disorder Patients, 2nd Psychiatric Clinic, Medical School of National Kapodistrian University of Athens: Attikon General University Hospital

Athens, Attica, 12462, Greece

RECRUITING

Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital

Athens, Attica, 15126, Greece

RECRUITING

Related Publications (22)

• National Collaborating Centre for Mental Health (UK). Borderline Personality Disorder: Treatment and Management. Leicester (UK): British Psychological Society (UK); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK55403/

  PMID: 21796831 BACKGROUND

• 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.

  PMID: 15843180 BACKGROUND

• 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.

  PMID: 24469526 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 19833787 BACKGROUND

• 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

  BACKGROUND

• Bateman, A., Fonagy, P. (2004) Suicide and self-harm inventory. In: Psychotherapy for Borderline Personality Disorder: Mentalization-based treatment. New York, NY: Oxford University Press.

  BACKGROUND

• Derogatis, L. R. (1993). BSI brief symptom inventory: Administration, scoring, and procedures manual (4th ed.). Minneapolis, MN: National Computer Systems.

  BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

• Horowitz, L. M., Alden, L., Wiggins, J., & Pincus, A. (2000). Inventory of Interpersonal Problems Manual. San Antonio, TX: The Psychological Corporation.

  BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.

  PMID: 21076562 BACKGROUND

• Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.

  PMID: 27392018 BACKGROUND

• Andrews G, Singh M, Bond M. The Defense Style Questionnaire. J Nerv Ment Dis. 1993 Apr;181(4):246-56. doi: 10.1097/00005053-199304000-00006.

  PMID: 8473876 BACKGROUND

• Lenzenweger MF, Clarkin JF, Kernberg OF, Foelsch PA. The Inventory of Personality Organization: psychometric properties, factorial composition, and criterion relations with affect, aggressive dyscontrol, psychosis proneness, and self-domains in a nonclinical sample. Psychol Assess. 2001 Dec;13(4):577-91.

  PMID: 11793901 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.

  PMID: 10158943 BACKGROUND

• 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.

  PMID: 25407009 BACKGROUND

• Bremner JD, Bolus R, Mayer EA. Psychometric properties of the Early Trauma Inventory-Self Report. J Nerv Ment Dis. 2007 Mar;195(3):211-8. doi: 10.1097/01.nmd.0000243824.84651.6c.

  PMID: 17468680 BACKGROUND

• First MB, Williams JBW, Benjamin LS, Spitzer RL: User's Guide for the SCID-5-PD (Structured Clinical Interview for DSM-5 Personality Disorder). Arlington, VA, American Psychiatric Association, 2015

  BACKGROUND

• American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596

  BACKGROUND

• 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.

  PMID: 40666438 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Therapeutics; Population Groups

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Ioannis A. Malogiannis, MD

CONTACT

+306945898082; ioannis.malogiannis@gmail.com

Lily E. Peppou

CONTACT

+306976925095; lilly.peppou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mr Ioannis A. Malogiannis, Head of the BPD Specific Sector

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 30, 2024
• Study Start: January 7, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)