Borderline personality disorder
Conditions
Interventions
Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration
Sponsors
Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of BPD according to two semi-structured interviews (SCID-II and DIB-R). 2) Ages between 18 and 50 years. 3) Stability in the pharmacological treatment during the performance of the intervention. 4) Having undergone previous treatment for BPD with standard TDC or TDC skills training. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Present comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain diseases, or mental retardation according to medical examination and clinical evaluation using SCID-I. 2) Present a history of serious endocrinological disorders. 3) Start with another psychotherapy treatment in parallel. 4) Not being in accepted contraceptive treatment. 5) Pregnancy desire or pregnancy planning during the study. The use of accepted contraceptive method will be required except hormonal treatment. 6) Being pregnant or breastfeeding during the study. 7) Being in medical treatment incompatible with the administration of oxytocin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To study the efficacy of the combined intervention: self compassion training (EA) + intranasal oxytocin (OI) aimed at increasing self-compassion and self-validation, in patients with borderline personality disorder (BPD) compared to the condition EA + placebo (PBO);Secondary Objective: - To study the effect of the combination (EA + LE) on the symptoms of BPD. - To explore the impact of (EA + OI) on the regulation of anger in BPD patients. - Explore the effect of (EA + OI) on the measure of judgment and self-criticism. - Explore the effect of (EA + LE) on the functionality of BPD patients. - To explore the effect of (EA + LE) on the psychological well-being of BPD patients assigned to this intervention.;Primary end point(s): Self-pity/self-invalidation measures: Self Compassion Scale Short Form; Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale.;Timepoint(s) of evaluation of this end point: 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Symptoms typical of BPD through the Borderline Symptoms List-23; Rabies symptomatology through the STAXI; Satisfaction with life: Satisfaction with life scale; Additional measures of well-being: Pemberton Happiness Index; Functionality measures: WHO quality of life scale WHO-QOL-BREF.;Timepoint(s) of evaluation of this end point: 5 weeks | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca H. Santa Creu i Sant Pau
Outcome results
None listed