Oxytocin Plus Self-compassion Training in Borderline Personality Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intranasal Oxytocin (IN-OXT), Intranasal Placebo, Self-Compassion Training (SCT).
- Who it may be relevant to
- Registry conditions: Self-compassion Training (SCT) Plus Intranasal Oxytocin, Self-compassion Training (SCT) Plus Intranasal Placebo. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Oxytocin Plus Self-compassion Training Combination in Patients With Borderline Personality Disorder
Overview
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.
Detailed description
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.
Interventions
- Drug Intranasal Oxytocin (IN-OXT)
24 UI oxytocin intranasal - Drug Intranasal Placebo
24 UI intranasal placebo - Behavioral Self-Compassion Training (SCT)
SCT consists of a 5 sessions of Self-Compassions meditation training
Primary outcome measures
- Self Compassion Scale Short Form (SCS-SF) [Time frame: 1 month]
Secondary outcome measures (5)
- Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF) [Time frame: 1 month]
- Borderline Symptoms List-23 (BSL-23) [Time frame: 1 week]
- Satisfaction with life scale (SWLS) [Time frame: 1 month]
- Pemberton Happiness Index (PHI) [Time frame: 1 month]
- OMS WHO-QOL-BREF( WHOQOL-Group, 1998). [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital de la Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT07551882 · IIBSP-OXI-2022-124