2024-515589-15-00招募中4 期
Controlled and randomized clinical trial to evaluate the efficacy of the combination of oxytocin plus Self-Compassion Training (SCT) in patients with Borderline Personality Disorder (BPD).
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月24日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).
研究概览
简要总结
Evaluate the therapeutic potential in Borderline Personality Disorder (BPD) of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) to facilitate the therapeutic process.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews (SCID-II and DIB-R).
- •Ages between 18 and 50 years old.
- •Stability of pharmacological treatment during the intervention.
- •Previous treatment for Borderline Personality Disorder (BPD) with standard Dialectical Behavioral Therapy (DBT) or Dialectical Behavioral Therapy (DBT) skills training.
- •High levels of self-criticism. Scores on the Inadequate Self (IS) subscale of the FSCRS-SF > 12.
排除标准
- •Comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain disease or mental retardation according to medical examination and clinical evaluation by SCID-I.
- •History of severe endocrinological disorders.
- •History of Epilepsy, Renal Insufficiency or Heart Failure.
- •Start another psychotherapy treatment in parallel.
- •Potentially fertile women unwilling to take contraceptive measures (oral contraception, intrauterine device, partner vasectomy, tubal ligation or sexual abstinence) during the entire study period.
- •Gestational desire or pregnancy planning during the study.
- •Being pregnant or breastfeeding during the study.
- •Being under medical treatment incompatible with the administration of oxytocin.
结局指标
主要结局
Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).
Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).
次要结局
- Self-criticism/self-aggression and self-reassurance scale-short form (FSCRS-SF; Gilbert et al., 2004, Navarrete et al. 2021).
- Symptomatology characteristic of Borderline Personality Disorder (BPD) through the Borderline Symptoms List-23 (BSL23; Bohus et al., 2009; Soler et al., 2013).
- Rage symptomatology through lSTAXI (Miguel-Tobal et al., 2001).
- Satisfaction with life: Satisfaction with life scale (SWLS; Diener et al., 1985; Atienza et al., 2000).
- Additional measures of well-being: Pemberton Happiness Index (PHI; Hervás et al., 2013).
- Measures of functionality: WHO Quality of Life Scale WHOQOL-BREF (WHOQOL-Group, 1998).
研究者
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Treatment of Borderline Personality Disorder With rTMSBorderline Personality DisorderNCT07197502University of California, Los Angeles30
已完成
2 期
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality DisorderBorderline Personality DisorderNCT04566601Boehringer Ingelheim390
Enrolling By Invitation
不适用
The Influence of Treatment Format on Schema Therapy for Borderline Personality DisorderBorderline Personality DisorderNCT05986552University of Amsterdam132
已完成
2 期
Psychodynamic Therapy For Co-occurring Borderline Personality Disorder and Alcohol Use DisorderAlcohol Use DisorderBorderline Personality DisorderNCT00145678State University of New York - Upstate Medical University30
招募中
不适用
A Mixed Intervention to Improve Resilience for Patient With Neurocognitive DisordersNCT06801171Centre Hospitalier Universitaire de Nice90