Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Официальное название

Efficacy of Oxytocin Plus Self-compassion Training Combination in Patients With Borderline Personality Disorder

Обзор

Background: Borderline personality disorder (BPD) is a frequentand serious psychiatric disorder characterized by a persistent pattern of instability in relationships, affect and self-image. Although long-term follow-up prospective studies have shown high clinical remission rates, they also point out that usually persist social functioning deficits, comorbidity, isolation, chronic affective clinic and life dissatisfaction. Self-compassion training (SCT) could be an effective strategy targeting self-criticism, shame and chronic feelings of worthlessness, as well as increasing resilience. In addition, the administration of intranasal oxytocin has proven useful in regulating social cognition, affiliation behaviors and enhancing empathy, key symptoms in this population. This combined intervention could be particularly appropriate for BPD patients. Objective: The objective of this project is to implement and evaluate the effectiveness of a combined intervention, based on SCT and intranasal oxytocin administration, for the treatment of patients with BPD. Methodology: Controlled and randomized clinical trial. A self-compassion training of 5 weeks duration plus intranasal oxytocin administration versus SCT plus placebo will be compared in a sample of 80 patients with BPD. Clinical and wellness measures will be evalutated as outcomes.

Подробное описание

Controlled clinical trial. A self-compassion training of 5 weeks duration plus intranasal oxytocin administration versus SCT plus placebo will be compared in a sample of 80 patients with BPD. Self-criticism, self-compassion, clinical and wellness measures will be evalutated as outcomes.

Вмешательства

• Препарат Intranasal Oxytocin (IN-OXT)
  24 UI oxytocin intranasal
• Препарат Intranasal Placebo
  24 UI intranasal placebo
• Поведенческое Self-Compassion Training (SCT)
  SCT consists of a 5 sessions of Self-Compassions meditation training

Первичные конечные точки

• Self Compassion Scale Short Form (SCS-SF) [Срок оценки: 1 month]

Вторичные конечные точки (5)

• Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF) [Срок оценки: 1 month]
• Borderline Symptoms List-23 (BSL-23) [Срок оценки: 1 week]
• Satisfaction with life scale (SWLS) [Срок оценки: 1 month]
• Pemberton Happiness Index (PHI) [Срок оценки: 1 month]
• OMS WHO-QOL-BREF( WHOQOL-Group, 1998). [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews: the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) and the Revised Diagnostic Interview for Borderlines (DIB-R).
• Aged between 18 and 50 years, inclusive.
• Pharmacological treatment stability maintained throughout the intervention period.
• Previous treatment for BPD, specifically Standard Dialectical Behavior Therapy (DBT) or DBT Skills Training.
• High levels of self-criticism, defined as scores > 12 on the Inadequate Self (IS) subscale of the Forms of Self-Criticizing/Attacking \& Self-Reassuring Scale - Short Form (FSCRS-SF).

Критерии исключения

• Presence of comorbid psychiatric disorders, including: Schizophrenia, Psychotic Disorders, Bipolar Disorder, Current Major Depressive Disorder (MDD), Substance Dependence, Organic Brain Disease, or Intellectual Disability, as determined by medical examination and clinical assessment using the SCID-I (Structured Clinical Interview for DSM-IV Axis I Disorders).
• History of severe endocrine disorders.
• History of medical conditions, specifically: Epilepsy, Renal Insufficiency (Kidney Failure), or Heart Failure.
• Concurrent participation in any other psychotherapy or psychological treatment during the study period.
• Women of childbearing potential who are unwilling or unable to use highly effective contraception (e.g., oral contraceptives, intrauterine device \[IUD\], partner's vasectomy, tubal ligation, or sexual abstinence) throughout the entire duration of the study.
• Intention to become pregnant or planning a pregnancy during the course of the study.
• Current pregnancy or breastfeeding at the time of enrollment or during the study.
• Concomitant medical treatment that is incompatible with the administration of intranasal oxytocin.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital de la Santa Creu i Sant Pau — Barcelona

Идентификаторы

NCT: NCT07551882 · IIBSP-OXI-2022-124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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