NCT07551882 Oxytocin Plus Self-compassion Training in Borderline Personality Disorder
| NCT ID | NCT07551882 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Self-compassion Training (SCT) Plus Intranasal Oxytocin |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-01-10 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Principal Investigator JCP Pascual, PhD
PRINCIPAL INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Frequently Asked Questions
Who can join the NCT07551882 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Self-compassion Training (SCT) Plus Intranasal Oxytocin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07551882 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07551882 currently recruiting?
Yes, NCT07551882 is actively recruiting participants. Contact the research team at psiquiatria@santpau.cat for enrollment information.
Where is the NCT07551882 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07551882 clinical trial?
NCT07551882 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The principal investigator is Principal Investigator JCP Pascual, PhD at Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 80 participants.