Other Mental Conditions
Conditions
Keywords
Borderline Personality Disorder
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.
Interventions
BEHAVIORALSpecific 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.
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.
Sponsors
National and Kapodistrian University of Athens
University Mental Health Research Institute, Athens, Greece
Sismanogleion General Hospital, 3rd Respiratory Medicine Department
Attikon Hospital
Ioannis A. Malogiannis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-Effectiveness | 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. |
| ALL 3 MECHANISMS OF CHANGE- RFQ, IPO-GR, DSQ-40 | Baseline, 1 year, 2 years | — |
| ETI - Early Trauma Inventory | 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. |
Countries
Greece
Contacts
Primary ContactIoannis A. Malogiannis, MD
Backup ContactLily E. Peppou
Outcome results
None listed