Oxytocin plus self-compassion training for borderline personality disorder

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

This will test whether adding intranasal oxytocin to a five-week self-compassion training helps adults with borderline personality disorder reduce self-criticism and improve social and emotional functioning.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (other)
• Locations: 1 site (Barcelona, Barcelona)
• Trial ID: NCT07551882 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 2 trial will enroll about 80 adults with confirmed borderline personality disorder to receive a five-week self-compassion training combined with either intranasal oxytocin or a placebo. Participants will be compared on measures of self-criticism, self-compassion, clinical symptoms, and overall well-being before and after the intervention. Eligible participants are aged 18–50, stable on medication, have prior DBT experience, and show high self-criticism on a validated scale. All visits and treatments are conducted at a single center in Barcelona.

Who should consider this trial

Good fit: Adults 18–50 with a confirmed BPD diagnosis by SCID-II and DIB-R, stable pharmacological treatment, prior DBT/DBT skills training, and high self-criticism (FSCRS-SF Inadequate Self > 12) are ideal candidates.

Not a fit: Patients with comorbid schizophrenia, psychotic disorders, bipolar disorder, current major depressive disorder, substance dependence, organic brain disease, intellectual disability, those outside the 18–50 age range, or those without elevated self-criticism may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the combined approach could reduce self-criticism and improve empathy, social functioning, and quality of life for people with BPD.

How similar studies have performed: Prior work suggests intranasal oxytocin can influence social cognition and compassion-focused therapies can lower self-criticism, but combining oxytocin with self-compassion training in BPD is relatively novel and not yet established.

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.

Where this trial is running

Barcelona, Barcelona

• Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (RECRUITING)

Study contacts

• Principal investigator: Principal Investigator JCP Pascual, PhD — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Study coordinator: Principal Investigator JCP JCP, PhD

Conditions: Self-compassion Training Plus Intranasal Oxytocin, Self-compassion Training Plus Intranasal Placebo, oxytocin, self-compassion therapy, controlled clinical trial