Specialized Healthcare Service for BPD Patients: Athens Trial (BPDAS)

April 26, 2024 updated by: Ioannis A. Malogiannis

A Quasi-experimental Pragmatic Trial Evaluating a Tailored Healthcare Service for Patients With Borderline Personality Disorder: Borderline Personality Disorder Athens Study (BPDAS)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Recruiting
        • 1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital
        • Contact:
        • Contact:
      • Athens, Attica, Greece, 12462
        • Recruiting
        • Outpatient Clinic for Borderline Personality Disorder Patients, 2nd Psychiatric Clinic, Medical School of National Kapodistrian University of Athens: Attikon General University Hospital
        • Contact:
      • Athens, Attica, Greece, 15126
        • Recruiting
        • Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • BPDAS
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009).
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
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
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
General psychiatric symptoms present at the time of assessment.
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
These will be assessed using the BSI (Brief Symptom Inventory): it is a self-report inventory of general psychiatric symptoms present at the time of assessment.
Baseline, 6 months, 1 year, 18 months, 2 years
Subjective Quality of Life
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
It will be assessed using WHOQOL BREF (World Health Organization Quality of Life questionnaire), which is a valid and reliable instrument for the assessment of the quality of life in the two prior weeks. It assesses various domains.
Baseline, 6 months, 1 year, 18 months, 2 years
Distress caused by interpersonal problems
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
It will be assessed using the IIP-64 (Inventory of interpersonal problems): it is a 64-item measure designed to determine sources of interpersonal distress.
Baseline, 6 months, 1 year, 18 months, 2 years
Functional Impairments in fields such as work and household
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
It will be assessed using WSAS (Work and Social Adjustment Scale): is a self-report instrument that rates functional impairment in the fields of work, household, social leisure, private leisure, family, and relationships.
Baseline, 6 months, 1 year, 18 months, 2 years
WHODAS II
Time Frame: Baseline, 6 months, 2 years
A generic assessment instrument for health and disability.
Baseline, 6 months, 2 years
Reflective Functioning
Time Frame: Baseline,1 year, 2 years
It will be assessed using the RFQ-8 (Reflective Functioning Questionnaire): is a brief, screening measure of reflective functioning. It has been developed to assess severe impairments or imbalances in mentalizing as typically observed in patients with borderline personality disorder features.
Baseline,1 year, 2 years
Defense tendency
Time Frame: Baseline,1 year, 2 years
It will be assessed using DSQ-40 (Defense Style Questionnaire): is a questionnaire of 40 items, aims to assess behavior indicative of conscious derivatives of defensive styles that correspond to hypothesized patterns of unconscious psychological mechanisms.
Baseline,1 year, 2 years
Personality Organisation
Time Frame: Baseline,1 year, 2 years
Measured using IPO-GR (Inventory of Personality Organization): it is a self-report instrument intended to measure a patient's level of personality organization.
Baseline,1 year, 2 years
Client Satisfaction Questionnaire
Time Frame: 6 months, 1 year, 18 months, 2 years
CSQ-8 The Client Satisfaction Questionnaire (CSQ) is one of the most used questionnaires for measuring patient-reported satisfaction in mental healthcare settings.
6 months, 1 year, 18 months, 2 years
Patients' health-related quality of life
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
A five-item self-report measure (EuroQol-5D-3L) will be used to assess five different dimensions of patients' health-related quality of life: self-care, mobility, usual activity, anxiety/depression, and pain/discomfort
Baseline, 6 months, 1 year, 18 months, 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-Effectiveness
Time Frame: Baseline, 6 months, 1 year, 18 months, 2 years
Αn interview will be conducted to retrospectively identify costs relevant to the experience of patients with BPD. These include health care costs (visits to general practitioners, hospitals, psychiatrists etc.), patient and family costs (travel costs, informal care, out-of-pocket costs, etc.), and costs in other sectors (productivity losses at work, volunteering work, and/or studying, etc.). The recall period for the interview is 6 months.
Baseline, 6 months, 1 year, 18 months, 2 years
ALL 3 MECHANISMS OF CHANGE- RFQ, IPO-GR, DSQ-40
Time Frame: Baseline, 1 year, 2 years
Baseline, 1 year, 2 years
ETI - Early Trauma Inventory
Time Frame: Baseline, 2 years
The self-report Early Trauma Inventory (ETI-SR-SF) was developed by Bremner et al in 2007 and has been proven a valid tool for the assessment of childhood trauma. The inventory covers four types of traumatic experiences: general trauma, physical abuse, emotional abuse and sexual abuse.
Baseline, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ioannis A. Malogiannis

Collaborators

National and Kapodistrian University of Athens
Attikon Hospital
University Mental Health Research Institute, Athens, Greece
Sismanogleion General Hospital, 3rd Respiratory Medicine Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 7, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 404/06-07-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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