Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 50

Oxytocin plus self-compassion training for borderline personality disorder

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

Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07551882 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 50 Years
SexAll
Enrollment80 (estimated)
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Academic / other
Locations1 site (Barcelona, Barcelona)
StatusRecruiting
StartedJanuary 10, 2024
Main results expectedJune 1, 2026
Study endsAugust 1, 2026
Registry record updatedApril 27, 2026
Trial IDNCT07551882 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: psiquiatria@santpau.cat
  • Phone: +34 93 553 78 40.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.