Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
NCT07551882

Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2026-04-27

80

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Borderline Personality Disorder (BPD) confirmed by SCID-II and DIB-R interviews
  • Age between 18 and 50 years, inclusive
  • Stable pharmacological treatment throughout the intervention
  • Previous treatment with Standard Dialectical Behavior Therapy (DBT) or DBT Skills Training
  • High self-criticism with scores above 12 on the Inadequate Self subscale of FSCRS-SF
Not Eligible

You will not qualify if you...

  • Presence of comorbid psychiatric disorders such as Schizophrenia, Psychotic Disorders, Bipolar Disorder, Current Major Depressive Disorder, Substance Dependence, Organic Brain Disease, or Intellectual Disability
  • History of severe endocrine disorders
  • History of Epilepsy, Renal Insufficiency, or Heart Failure
  • Concurrent participation in other psychotherapy or psychological treatments
  • Women of childbearing potential unwilling or unable to use effective contraception throughout the study
  • Intention to become pregnant or planning pregnancy during the study
  • Current pregnancy or breastfeeding at enrollment or during the study
  • Use of medical treatments incompatible with intranasal oxytocin administration

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain, 08041

Actively Recruiting

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Research Team

P

Principal Investigator JCP JCP, PhD

CONTACT

C

Co-IP (JS) JS J Soler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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