Clinical trial NCT06392139: Specialized Healthcare Service for BPD Patients: Athens Trial
Official title: A Quasi-experimental Pragmatic Trial Evaluating a Tailored Healthcare Service for Patients With Borderline Personality Disorder: Borderline Personality Disorder Athens Study (BPDAS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Other Mental Conditions
Keywords: Borderline Personality Disorder
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: University Mental Health Research Institute, Athens, Greece
name: Sismanogleion General Hospital, 3rd Respiratory Medicine Department
name: Attikon Hospital
First posted: 2024-04-30
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009).
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: Suicide Harm Inventory
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
Secondary outcomes:
measure: General psychiatric symptoms present at the time of assessment.
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: Subjective Quality of Life
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: Distress caused by interpersonal problems
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: Functional Impairments in fields such as work and household
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: WHODAS II
timeFrame: Baseline, 6 months, 2 years
measure: Reflective Functioning
timeFrame: Baseline,1 year, 2 years
measure: Defense tendency
timeFrame: Baseline,1 year, 2 years
measure: Personality Organisation
timeFrame: Baseline,1 year, 2 years
measure: Client Satisfaction Questionnaire
timeFrame: 6 months, 1 year, 18 months, 2 years
measure: Patients' health-related quality of life
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
Other outcomes:
measure: Cost-Effectiveness
timeFrame: Baseline, 6 months, 1 year, 18 months, 2 years
measure: ALL 3 MECHANISMS OF CHANGE- RFQ, IPO-GR, DSQ-40
timeFrame: Baseline, 1 year, 2 years
measure: ETI - Early Trauma Inventory
timeFrame: Baseline, 2 years
Locations:
city: Athens
country: Greece
facility: 1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital
state: Attica
city: Athens
country: Greece
facility: Outpatient Clinic for Borderline Personality Disorder Patients, 2nd Psychiatric Clinic, Medical School of National Kapodistrian University of Athens: Attikon General University Hospital
state: Attica
city: Athens
country: Greece
facility: Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital
state: Attica
Study officials:
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