Other Mental ConditionsBPDASNCT06392139
Specialized Healthcare Service for BPD Patients: Athens Trial
A study testing Specific Therapy Program for Personality Disorders and Treatment As Usual (TAU) Group in people with Other Mental Conditions, run by Ioannis A. Malogiannis at 3 sites in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Other Mental Conditions
- What is being tested?
- Specific Therapy Program for Personality Disorders and Treatment As Usual (TAU) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesGreece
- Study dates
- 7 Jan 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary diagnosis of BPD (diagnosed with Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD and
- willingness to participate in the study.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Greece3 sites, 3 recruiting
- Recruiting
1st Psychiatric Clinic, Medical School, National Kapodistrian University of Athens, Eginition Hospital
Athens, Attica, 11528
Ioannis A. Malogiannis, MD, +306945898082, ioannis.malogiannis@gmail.com
Lily E. Peppou, +306976925095, lilly.peppou@gmail.com
- Recruiting
Outpatient Clinic for Borderline Personality Disorder Patients, 2nd Psychiatric Clinic, Medical School of National Kapodistrian University of Athens: Attikon General University Hospital
Athens, Attica, 12462
Panagiotis Aristotelidis, MD, +306944153008, panaristotelidis@gmail.com
- Recruiting
Outpatient Clinic for Borderline Personality Disorder Patients, Psychiatric Clinic of Sismanogleion General Hospital
Athens, Attica, 15126
Maria Aspradaki, MD, +306946697252, maria_asp@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Other Mental Conditions
- Being tested
- Specific Therapy Program for Personality Disorders, Treatment As Usual (TAU) Group
- Keywords
- Borderline Personality Disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Therapy Program for Personality DisordersBehavioural
Also called BPDAS
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.
Treatment As Usual (TAU) GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | 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. Receives: Behavioral: Specific Therapy Program for Personality Disorders |
| Treatment As Usual (TAU) Group | Active comparator | 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. Receives: Other: Treatment As Usual (TAU) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of BPD and severe parasuicidal behavior as defined by Bateman and Fonagy (2009).
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Suicide Harm Inventory
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Secondary outcomes (10)
General psychiatric symptoms present at the time of assessment.
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Subjective Quality of Life
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Distress caused by interpersonal problems
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Functional Impairments in fields such as work and household
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.
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
WHODAS II
A generic assessment instrument for health and disability.
Measured: Baseline, 6 months, 2 years
Reflective Functioning
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.
Measured: Baseline,1 year, 2 years
Defense tendency
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.
Measured: Baseline,1 year, 2 years
Personality Organisation
Measured using IPO-GR (Inventory of Personality Organization): it is a self-report instrument intended to measure a patient's level of personality organization.
Measured: Baseline,1 year, 2 years
Client Satisfaction Questionnaire
CSQ-8 The Client Satisfaction Questionnaire (CSQ) is one of the most used questionnaires for measuring patient-reported satisfaction in mental healthcare settings.
Measured: 6 months, 1 year, 18 months, 2 years
Patients' health-related quality of life
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
Measured: Baseline, 6 months, 1 year, 18 months, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Jan 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Other Mental ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ioannis A. Malogiannis
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University Mental Health Research Institute, Athens, Greece, Sismanogleion General Hospital, 3rd Respiratory Medicine Department, Attikon Hospital
- Responsible party
- Sponsor-investigator, Ioannis A. Malogiannis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392139
- Sponsor's protocol ID
- No. 404/06-07-2021
- Acronym
- BPDAS
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Collaborating Centre for Mental Health (UK). Borderline Personality Disorder: Treatment and Management. Leicester (UK): British Psychological Society (UK); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK55403/
PubMed 21796831Vaslamatzis G, Coccossis M, Zervis C, Panagiotopoulou V, Chatziandreou M. A psychoanalytically oriented combined treatment approach for severely disturbed borderline patients: the Athens project. Bull Menninger Clin. 2004 Fall;68(4):337-49. doi: 10.1521/bumc.68.4.337.56640.
PubMed 15843180Vaslamatzis G, Theodoropoulos P, Vondikaki S, Karamanolaki H, MiliaTsanira M, Gourounti K. Is the residential combined (psychotherapy plus medication) treatment of patients with severe personality disorder effective in terms of suicidality and impulsivity? J Nerv Ment Dis. 2014 Feb;202(2):138-43. doi: 10.1097/NMD.0000000000000083.
PubMed 24469526E. Layiou-Lignos, L. Anagnostaki, I. Malogiannis & H. Karamanolaki (2021): The psychoanalytic psychotherapy endeavor in the Greek public sector, Psychoanalytic Psychotherapy, DOI: 10.1080/02668734.2021.1898045
Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.
PubMed 19833787Leibniz Institute for Psychology (ZPID). (2019). Open Test Archive: BPDSI-IV. Borderline Personality Disorder Severity Index (Version IV) - deutsche Fassung. Available at: https://www.testarchiv.eu/en/test/9007150κ
Bateman, A., Fonagy, P. (2004) Suicide and self-harm inventory. In: Psychotherapy for Borderline Personality Disorder: Mentalization-based treatment. New York, NY: Oxford University Press.
Derogatis, L. R. (1993). BSI brief symptom inventory: Administration, scoring, and procedures manual (4th ed.). Minneapolis, MN: National Computer Systems.
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Horowitz, L. M., Alden, L., Wiggins, J., & Pincus, A. (2000). Inventory of Interpersonal Problems Manual. San Antonio, TX: The Psychological Corporation.
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
PubMed 21076562Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PubMed 27392018Andrews G, Singh M, Bond M. The Defense Style Questionnaire. J Nerv Ment Dis. 1993 Apr;181(4):246-56. doi: 10.1097/00005053-199304000-00006.
PubMed 8473876Lenzenweger MF, Clarkin JF, Kernberg OF, Foelsch PA. The Inventory of Personality Organization: psychometric properties, factorial composition, and criterion relations with affect, aggressive dyscontrol, psychosis proneness, and self-domains in a nonclinical sample. Psychol Assess. 2001 Dec;13(4):577-91.
PubMed 11793901
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-experimental Pragmatic Trial Evaluating a Tailored Healthcare Service for Patients With Borderline Personality Disorder: Borderline Personality Disorder Athens Study (BPDAS)
- ClinicalTrials.gov ID
- NCT06392139
- Acronym / sponsor ID
- BPDAS / No. 404/06-07-2021
- Conditions
- Other Mental Conditions
- Keywords
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Ioannis A. MalogiannisUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University Mental Health Research Institute, Athens, Greece, Sismanogleion General Hospital, 3rd Respiratory Medicine Department, Attikon Hospital
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Behavioral: Specific Therapy Program for Personality DisordersThe 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 As Usual (TAU) Group | Active comparator | Other: Treatment As Usual (TAU) GroupThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary diagnosis of BPD (diagnosed with Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD and
- willingness to participate in the study.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Therapy Program for Personality DisordersAlso: BPDASThe 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. | Behavioural | Experimental: Intervention group |
| Treatment As Usual (TAU) GroupThe 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. | Other | Treatment As Usual (TAU) Group |
Primary outcome
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.
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.
10 secondary outcomes
General psychiatric symptoms present at the time of assessment.
Time frame: Baseline, 6 months, 1 year, 18 months, 2 years
Subjective Quality of Life
Time frame: 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
Functional Impairments in fields such as work and household
Time frame: Baseline, 6 months, 1 year, 18 months, 2 years
WHODAS II
Time frame: Baseline, 6 months, 2 years
Reflective Functioning
Time frame: Baseline,1 year, 2 years
Defense tendency
Time frame: Baseline,1 year, 2 years
Personality Organisation
Time frame: Baseline,1 year, 2 years
Client Satisfaction Questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 21796831National Collaborating Centre for Mental Health (UK). Borderline Personality Disorder: Treatment and Management. Leicester (UK): British Psychological Society (UK); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK55403/
- Background: PubMed 15843180Vaslamatzis G, Coccossis M, Zervis C, Panagiotopoulou V, Chatziandreou M. A psychoanalytically oriented combined treatment approach for severely disturbed borderline patients: the Athens project. Bull Menninger Clin. 2004 Fall;68(4):337-49. doi: 10.1521/bumc.68.4.337.56640.
- Background: PubMed 24469526Vaslamatzis G, Theodoropoulos P, Vondikaki S, Karamanolaki H, MiliaTsanira M, Gourounti K. Is the residential combined (psychotherapy plus medication) treatment of patients with severe personality disorder effective in terms of suicidality and impulsivity? J Nerv Ment Dis. 2014 Feb;202(2):138-43. doi: 10.1097/NMD.0000000000000083.
- BackgroundE. Layiou-Lignos, L. Anagnostaki, I. Malogiannis & H. Karamanolaki (2021): The psychoanalytic psychotherapy endeavor in the Greek public sector, Psychoanalytic Psychotherapy, DOI: 10.1080/02668734.2021.1898045
- Background: PubMed 19833787Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.
- BackgroundLeibniz Institute for Psychology (ZPID). (2019). Open Test Archive: BPDSI-IV. Borderline Personality Disorder Severity Index (Version IV) - deutsche Fassung. Available at: https://www.testarchiv.eu/en/test/9007150κ
- BackgroundBateman, A., Fonagy, P. (2004) Suicide and self-harm inventory. In: Psychotherapy for Borderline Personality Disorder: Mentalization-based treatment. New York, NY: Oxford University Press.
- BackgroundDerogatis, L. R. (1993). BSI brief symptom inventory: Administration, scoring, and procedures manual (4th ed.). Minneapolis, MN: National Computer Systems.
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- BackgroundHorowitz, L. M., Alden, L., Wiggins, J., & Pincus, A. (2000). Inventory of Interpersonal Problems Manual. San Antonio, TX: The Psychological Corporation.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Background: PubMed 21076562Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Therapy Program for Personality Disorders and Treatment As Usual (TAU) Group in people with Other Mental Conditions, run by Ioannis A. Malogiannis at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioannis A. Malogiannis, MD (+306945898082, ioannis.malogiannis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392139, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.