E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Borderline personality disorder |
Trastorno Límite de la Personalidad |
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E.1.1.1 | Medical condition in easily understood language |
Borderline personality disorder |
Trastorno Límite de la Personalidad |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-To study the efficacy of the combined intervention: self compassion training (EA) + intranasal oxytocin (OI) aimed at increasing self-compassion and self-validation, in patients with borderline personality disorder (BPD) compared to the condition EA + placebo (PBO) |
-Estudiar la eficacia de la intervención combinada de Entrenamiento en autocompasión (EA) + Oxitocina Intranasal (OI), orientada al incremento de la autocompasión y autovalidación, en pacientes con Trastorno Límite Personalidad (TLP) en comparación con la condición EA + placebo (PBO) |
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E.2.2 | Secondary objectives of the trial |
- To study the effect of the combination (EA + LE) on the symptoms of BPD. - To explore the impact of (EA + OI) on the regulation of anger in BPD patients. - Explore the effect of (EA + OI) on the measure of judgment and self-criticism. - Explore the effect of (EA + LE) on the functionality of BPD patients. - To explore the effect of (EA + LE) on the psychological well-being of BPD patients assigned to this intervention. |
- Estudiar el efecto de la combinación (EA + OI) en la sintomatología propia del TLP. - Explorar el impacto del (EA + OI) en la regulación de la rabia de los pacientes TLP. - Explorar el efecto del (EA + OI) en la medida de juicio y autocrítica. - Explorar el efecto del (EA + OI) en la funcionalidad de los pacientes TLP. - Explorar el efecto del (EA + OI) en el bienestar psicológico de los pacientes TLP asignados a esta intervención. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Diagnosis of BPD according to two semi-structured interviews (SCID-II and DIB-R). 2) Ages between 18 and 50 years. 3) Stability in the pharmacological treatment during the performance of the intervention. 4) Having undergone previous treatment for BPD with standard TDC or TDC skills training. |
1) Diagnóstico de TLP según dos entrevistas semiestructuradas. 2) Edades entre los 18 y 50 años. 3) Estabilidad en el tratamiento farmacológico durante la realización de la intervención. 4) Haber realizado un tratamiento previo para TLP con TDC estándar o entrenamiento de habilidades de la TDC. |
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E.4 | Principal exclusion criteria |
1) Present comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain diseases, or mental retardation according to medical examination and clinical evaluation using SCID-I. 2) Present a history of serious endocrinological disorders. 3) Start with another psychotherapy treatment in parallel. 4) Not being in accepted contraceptive treatment. 5) Pregnancy desire or pregnancy planning during the study. The use of accepted contraceptive method will be required except hormonal treatment. 6) Being pregnant or breastfeeding during the study. 7) Being in medical treatment incompatible with the administration of oxytocin. |
1) Presentar comorbilidad con: esquizofrenia, psicosis, trastorno bipolar, trastorno depresivo mayor en curso, dependencia de sustancias, enfermedades orgánicas cerebrales o retraso mental según exploración médica y evaluación clínica mediante SCID-I. 2) Presentar antecedentes de trastornos endocrinológicos graves. 3) Comenzar con otro tratamiento en psicoterapia de forma paralela. 4) No estar en tratamiento anticonceptivo aceptado. 5) Deseo gestacional ni planificación del embarazo durante la realización del estudio. Se requerirá el uso de método anticonceptivo aceptado excepto el tratamiento hormonal. 6) Estar embarazada o en lactancia materna durante la realización del estudio. 7) Estar en tratamiento médico incompatible con la administración de oxitocina. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Self-pity/self-invalidation measures: Self Compassion Scale Short Form; Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale. |
Medidas de autocompasión/autoinvalidación: Self Compassion Scale Short Form; Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Symptoms typical of BPD through the Borderline Symptoms List-23; Rabies symptomatology through the STAXI; Satisfaction with life: Satisfaction with life scale; Additional measures of well-being: Pemberton Happiness Index; Functionality measures: WHO quality of life scale WHO-QOL-BREF. |
Sintomatología propia de TLP a través de la Borderline Symptoms List-23; Sintomatología de rabia a través del STAXI; Satisfacción con la vida: Satisfaction with life scale; Medidas adicionales de bienestar: Índice de felicidad Pemberton Happiness Index; Medidas de funcionalidad: Escala de calidad de vida de la OMS WHO-QOL-BREF. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |