Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

NCT07551882 | Recruiting Phase 2 DMC

• 1 other identifier: IIBSP-OXI-2022-124
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Self-compassion Training (SCT) Plus Intranasal Oxytocin; Self-compassion Training (SCT) Plus Intranasal Placebo

Keywords

oxytocin; self-compassion therapy; controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Self Compassion Scale Short Form (SCS-SF)

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

  1 month

Secondary Outcomes (5)

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

  1 month

• Borderline Symptoms List-23 (BSL-23)

  1 week

• Satisfaction with life scale (SWLS)

  1 month

• Pemberton Happiness Index (PHI)

  1 month

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

  2 weeks

Study Arms (2)

Self-compassion training (SCT) plus intranasal oxytocin

EXPERIMENTAL

Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin

Drug: Intranasal Oxytocin (IN-OXT); Behavioral: Self-Compassion Training (SCT)

Self-compassion training (SCT) plus intranasal placebo

PLACEBO COMPARATOR

Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo

Drug: Intranasal Placebo; Behavioral: Self-Compassion Training (SCT)

Interventions

Intranasal Oxytocin (IN-OXT) DRUG

24 UI oxytocin intranasal

Self-compassion training (SCT) plus intranasal oxytocin

Intranasal Placebo DRUG

24 UI intranasal placebo

Self-compassion training (SCT) plus intranasal placebo

Self-Compassion Training (SCT) BEHAVIORAL

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

Self-compassion training (SCT) plus intranasal oxytocin; Self-compassion training (SCT) plus intranasal placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Spondylocarpotarsal synostosis

Study Officials

• Principal Investigator JCP Pascual, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator JCP JCP, PhD

CONTACT

+34 93 553 78 40.; psiquiatria@santpau.cat

Co-IP (JS) JS J Soler

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 27, 2026
• Study Start: January 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication
• Access Criteria: Proposals should be directed to PI. To gain access, data requestors will need to sign a data access agreement and provide a methodologically sound proposal.

Locations

ES (1)