Self-compassion Training (SCT) Plus Intranasal OxytocinPhase 2NCT07551882
Oxytocin Plus Self-compassion Training in Borderline Personality Disorder
A Phase 2 study testing Intranasal Oxytocin (IN-OXT) and Self-Compassion Training (SCT) in people with Self-compassion Training (SCT) Plus Intranasal Oxytocin and Self-compassion Training (SCT) Plus Intranasal Placebo, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Self-compassion Training (SCT) Plus Intranasal Oxytocin, Self-compassion Training (SCT) Plus Intranasal Placebo
- What is being tested?
- Intranasal Oxytocin (IN-OXT) and Self-Compassion Training (SCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2024to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Co-IP (JS) JS J Soler contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
JC. Pascual Pascual, +34 93 553 78 40., psiquiatria@santpau.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- Self-compassion Training (SCT) Plus Intranasal Oxytocin, Self-compassion Training (SCT) Plus Intranasal Placebo
- Being tested
- Intranasal Oxytocin (IN-OXT), Intranasal Placebo, Self-Compassion Training (SCT)
- Keywords
- oxytocin; self-compassion therapy; controlled clinical trial
- Medical subject headings
- Spondylocarpotarsal synostosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Oxytocin (IN-OXT)Drug
24 UI oxytocin intranasal
Intranasal PlaceboDrug
24 UI intranasal placebo
Self-Compassion Training (SCT)Behavioural
SCT consists of a 5 sessions of Self-Compassions meditation training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Intranasal Placebo; Behavioral: Self-Compassion Training (SCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Compassion Scale Short Form (SCS-SF)
Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse
Measured: 1 month
Secondary outcomes (5)
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
Measured: 1 month
Borderline Symptoms List-23 (BSL-23)
Self-reported Borderline Symptoms scale (minimum 0- maximum 92). Higher scores worse
Measured: 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
Measured: 1 month
Pemberton Happiness Index (PHI)
Pemberton Happiness Index (minimum 0 - maximum 110). Higher scores better
Measured: 1 month
OMS WHO-QOL-BREF( WHOQOL-Group, 1998).
Quality of life OMS (26 items, minimum 26 - maximum 130). Higher scores better
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start10 Jan 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-compassion Training (SCT) Plus Intranasal OxytocinStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Soler, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Principal Investigator JCP Pascual, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551882
- Sponsor's protocol ID
- IIBSP-OXI-2022-124
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxytocin Plus Self-compassion Training Combination in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT07551882
- Acronym / sponsor ID
- IIBSP-OXI-2022-124
- Conditions
- Self-compassion Training (SCT) Plus Intranasal Oxytocin, Self-compassion Training (SCT) Plus Intranasal Placebo
- Keywords
- oxytocin; self-compassion therapy; controlled clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion training (SCT) plus intranasal oxytocin | Experimental | Drug: Intranasal Oxytocin (IN-OXT), Behavioral: Self-Compassion Training (SCT)Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin |
| Self-compassion training (SCT) plus intranasal placebo | Placebo comparator | Drug: Intranasal Placebo, Behavioral: Self-Compassion Training (SCT)Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Oxytocin (IN-OXT)24 UI oxytocin intranasal | Drug | Self-compassion training (SCT) plus intranasal oxytocin |
| Intranasal Placebo24 UI intranasal placebo | Drug | Self-compassion training (SCT) plus intranasal placebo |
| Self-Compassion Training (SCT)SCT consists of a 5 sessions of Self-Compassions meditation training | Behavioural | Self-compassion training (SCT) plus intranasal oxytocin, Self-compassion training (SCT) plus intranasal placebo |
Primary outcome
Self Compassion Scale Short Form (SCS-SF)
Time frame: 1 month
Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse
5 secondary outcomes
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF)
Time frame: 1 month
Borderline Symptoms List-23 (BSL-23)
Time frame: 1 week
Satisfaction with life scale (SWLS)
Time frame: 1 month
Pemberton Happiness Index (PHI)
Time frame: 1 month
OMS WHO-QOL-BREF( WHOQOL-Group, 1998).
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Co-IP (JS) JS J Soler contact
Principal Investigator JCP Pascual, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Oxytocin (IN-OXT) and Self-Compassion Training (SCT) in people with Self-compassion Training (SCT) Plus Intranasal Oxytocin and Self-compassion Training (SCT) Plus Intranasal Placebo, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator JCP JCP, PhD (+34 93 553 78 40., psiquiatria@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Compassion Scale Short Form (SCS-SF) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.