Specialized Healthcare Service for BPD Patients: Athens Trial
- Conditions
- Other Mental Conditions
- Interventions
- Other: Treatment As Usual (TAU) GroupBehavioral: Specific Therapy Program for Personality Disorders
- Registration Number
- NCT06392139
- Lead Sponsor
- Ioannis A. Malogiannis
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- primary diagnosis of BPD (diagnosed with Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD and
- willingness to participate in the study.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment As Usual (TAU) Group 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. Experimental: Intervention group Specific Therapy Program for Personality Disorders 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.
- Primary Outcome Measures
Name Time Method Suicide Harm Inventory 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.
Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009). 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.
- Secondary Outcome Measures
Name Time Method Reflective Functioning 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.
Defense tendency 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.
Functional Impairments in fields such as work and household 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.
WHODAS II Baseline, 6 months, 2 years A generic assessment instrument for health and disability.
Personality Organisation 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.
Client Satisfaction Questionnaire 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.
Patients' health-related quality of life 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
Subjective Quality of Life 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.
Distress caused by interpersonal problems 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.
General psychiatric symptoms present at the time of assessment. 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.
Trial Locations
- Locations (3)
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
1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital
🇬🇷Athens, Attica, Greece
Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital
🇬🇷Athens, Attica, Greece