Efficacy of Oxytocin Plus Self-compassion Training Combination in Patients With Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Self Compassion Scale Short Form (SCS-SF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Self-compassion training (SCT) plus intranasal oxytocin
Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin
干预措施: Intranasal Oxytocin (IN-OXT) (Drug)
Self-compassion training (SCT) plus intranasal oxytocin
Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin
干预措施: Self-Compassion Training (SCT) (Behavioral)
Self-compassion training (SCT) plus intranasal placebo
Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo
干预措施: Intranasal Placebo (Drug)
Self-compassion training (SCT) plus intranasal placebo
Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo
干预措施: Self-Compassion Training (SCT) (Behavioral)
结局指标
主要结局
Self Compassion Scale Short Form (SCS-SF)
时间窗: 1 month
Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse
次要结局
- Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF)(1 month)
- Borderline Symptoms List-23 (BSL-23)(1 week)
- Satisfaction with life scale (SWLS)(1 month)
- Pemberton Happiness Index (PHI)(1 month)
- OMS WHO-QOL-BREF( WHOQOL-Group, 1998).(2 weeks)
研究者
Joaquim Soler
Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau