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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin (IN-OXT) | Drug | 24 UI oxytocin intranasal |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator JCP JCP, PhD | Contact | +34 93 553 78 40. | psiquiatria@santpau.cat | |
| Co-IP (JS) JS J Soler | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator JCP Pascual, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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.
Data will be available beginning 6 months and ending 36 months following article publication
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.
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| Intranasal Placebo | Drug | 24 UI intranasal placebo |
|
| Self-Compassion Training (SCT) | Behavioral | SCT consists of a 5 sessions of Self-Compassions meditation training |
|
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 |
| ID | Term |
|---|---|
| C535780 | Spondylocarpotarsal synostosis |
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