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

Ioannis A. Malogiannis

Status: Enrolling

Conditions: Other Mental Conditions

Treatments: Other: Treatment As Usual (TAU) Group; Behavioral: Specific Therapy Program for Personality Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT06392139

No. 404/06-07-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Experimental: Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Specific Therapy Program for Personality Disorders

Treatment As Usual (TAU) Group

Active Comparator group

Description:

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:

Other: Treatment As Usual (TAU) Group