Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Efficacy of Oxytocin Plus Self-compassion Training Combination in Patients With 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.

Study Overview

• Status: Recruiting
• Conditions: Self-compassion Training (SCT) Plus Intranasal Oxytocin; Self-compassion Training (SCT) Plus Intranasal Placebo
• Intervention / Treatment: Drug: Intranasal Oxytocin (IN-OXT); Behavioral: Self-Compassion Training (SCT); Drug: Intranasal Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Principal Investigator JCP JCP, PhD; Phone Number: +34 93 553 78 40.; Email: psiquiatria@santpau.cat
• Study Contact Backup: Name: Co-IP (JS) JS J Soler

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08041
      • Recruiting
      • Hospital De La Santa Creu I Sant Pau
      • Contact: JC. Pascual Pascual; Phone Number: +34 93 553 78 40.; Email: psiquiatria@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-compassion training (SCT) plus intranasal oxytocin; Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin	Drug: Intranasal Oxytocin (IN-OXT); 24 UI oxytocin intranasal; Behavioral: Self-Compassion Training (SCT); SCT consists of a 5 sessions of Self-Compassions meditation training
Placebo Comparator: Self-compassion training (SCT) plus intranasal placebo; Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo	Behavioral: Self-Compassion Training (SCT); SCT consists of a 5 sessions of Self-Compassions meditation training; Drug: Intranasal Placebo; 24 UI intranasal placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Compassion Scale Short Form (SCS-SF)	Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF)	Self-reported Self-Criticism scale (14 items, minimum 0- maximum 56). Higher scores worse	1 month
Borderline Symptoms List-23 (BSL-23)	Self-reported Borderline Symptoms scale (minimum 0- maximum 92). Higher scores worse	1 week
Satisfaction with life scale (SWLS)	Self-reported satisfaction with life scale (SWLS), well being (5 items, minimum 5 - maximum 25). Higher scores better	1 month
Pemberton Happiness Index (PHI)	Pemberton Happiness Index (minimum 0 - maximum 110). Higher scores better	1 month
OMS WHO-QOL-BREF( WHOQOL-Group, 1998).	Quality of life OMS (26 items, minimum 26 - maximum 130). Higher scores better	2 weeks

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Principal Investigator JCP Pascual, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: oxytocin; self-compassion therapy; controlled clinical trial
• Additional Relevant MeSH Terms: Spondylocarpotarsal synostosis
• Other Study ID Numbers: IIBSP-OXI-2022-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available. Proposals should be directed to PI. To gain access, data requestors will provide a methodologically sound proposal.
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No