Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07551882

Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Self-compassion Training (SCT) Plus Intranasal Oxytocin Self-compassion Training (SCT) Plus Intranasal Placebo Spondylocarpotarsal synostosis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intranasal Oxytocin (IN-OXT)

Drug

24 UI oxytocin intranasal

Intranasal placebo

Drug

24 UI intranasal placebo

Self-Compassion Training (SCT)

Behavioral

SCT consists of a 5 sessions of Self-Compassions meditation training

Primary outcomes

  1. Self Compassion Scale Short Form (SCS-SF)

    Time frame: 1 month

    Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse

Secondary outcomes

  1. Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF)

    Time frame: 1 month

    Self-reported Self-Criticism scale (14 items, minimum 0- maximum 56). Higher scores worse

  2. Borderline Symptoms List-23 (BSL-23)

    Time frame: 1 week

    Self-reported Borderline Symptoms scale (minimum 0- maximum 92). Higher scores worse

  3. Satisfaction with life scale (SWLS)

    Time frame: 1 month

    Self-reported satisfaction with life scale (SWLS), well being (5 items, minimum 5 - maximum 25). Higher scores better

  4. Pemberton Happiness Index (PHI)

    Time frame: 1 month

    Pemberton Happiness Index (minimum 0 - maximum 110). Higher scores better

  5. OMS WHO-QOL-BREF( WHOQOL-Group, 1998).

    Time frame: 2 weeks

    Quality of life OMS (26 items, minimum 26 - maximum 130). Higher scores better

Study contacts

Contact information is provided by the study sponsor or research team.

Co-IP (JS) JS J Soler

CONTACT

Principal Investigator JCP JCP, PhD

CONTACT

[email protected]

+34 93 553 78 40.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.