OXYTOCIN for Borderline Personality Disorder

Inclusion criteria

• {"criterion_text":"- Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews (SCID-II and DIB-R).\n- Ages between 18 and 50 years old.\n- Stability of pharmacological treatment during the intervention.\n- Previous treatment for Borderline Personality Disorder (BPD) with standard Dialectical Behavioral Therapy (DBT) or Dialectical Behavioral Therapy (DBT) skills training.\n- High levels of self-criticism. Scores on the Inadequate Self (IS) subscale of the FSCRS-SF > 12."}

Exclusion criteria

• {"criterion_text":"- Comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain disease or mental retardation according to medical examination and clinical evaluation by SCID-I.\n- History of severe endocrinological disorders.\n- History of Epilepsy, Renal Insufficiency or Heart Failure.\n- Start another psychotherapy treatment in parallel.\n- Potentially fertile women unwilling to take contraceptive measures (oral contraception, intrauterine device, partner vasectomy, tubal ligation or sexual abstinence) during the entire study period.\n- Gestational desire or pregnancy planning during the study.\n- Being pregnant or breastfeeding during the study.\n- Being under medical treatment incompatible with the administration of oxytocin."}

Primary endpoints

• {"endpoint_text":"- Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).","definition_or_measurement_approach":"Measured using the Self Compassion Scale Short Form (SCS-SF)."}

Secondary endpoints

• {"endpoint_text":"- Self-criticism/self-aggression and self-reassurance scale-short form (FSCRS-SF; Gilbert et al., 2004, Navarrete et al. 2021).","definition_or_measurement_approach":"Measured using the FSCRS-SF instrument."}
• {"endpoint_text":"- Symptomatology characteristic of Borderline Personality Disorder (BPD) through the Borderline Symptoms List-23 (BSL23; Bohus et al., 2009; Soler et al., 2013).","definition_or_measurement_approach":"Measured using the Borderline Symptoms List-23 (BSL23)."}
• {"endpoint_text":"- Rage symptomatology through lSTAXI (Miguel-Tobal et al., 2001).","definition_or_measurement_approach":"Measured using the STAXI instrument."}
• {"endpoint_text":"- Satisfaction with life: Satisfaction with life scale (SWLS; Diener et al., 1985; Atienza et al., 2000).","definition_or_measurement_approach":"Measured using the Satisfaction With Life Scale (SWLS)."}
• {"endpoint_text":"- Additional measures of well-being: Pemberton Happiness Index (PHI; Hervás et al., 2013).","definition_or_measurement_approach":"Measured using the Pemberton Happiness Index (PHI)."}
• {"endpoint_text":"- Measures of functionality: WHO Quality of Life Scale WHOQOL-BREF (WHOQOL-Group, 1998).","definition_or_measurement_approach":"Measured using the WHOQOL-BREF quality of life instrument."}

Spain

Earliest CTIS Part Ii Submission Date

24-07-2024

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

217

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain