Self-compassion Training (SCT) Plus Intranasal Oxytocin, Self-compassion Training (SCT) Plus Intranasal Placebo
Conditions
Keywords
oxytocin; self-compassion therapy; controlled clinical trial
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.
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.
Interventions
24 UI oxytocin intranasal
DRUGIntranasal Placebo
24 UI intranasal placebo
BEHAVIORALSelf-Compassion Training (SCT)
SCT consists of a 5 sessions of Self-Compassions meditation training
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Compassion Scale Short Form (SCS-SF) | 1 month | Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF) | 1 month | Self-reported Self-Criticism scale (14 items, minimum 0- maximum 56). Higher scores worse |
| Borderline Symptoms List-23 (BSL-23) | 1 week | Self-reported Borderline Symptoms scale (minimum 0- maximum 92). Higher scores worse |
| Satisfaction with life scale (SWLS) | 1 month | Self-reported satisfaction with life scale (SWLS), well being (5 items, minimum 5 - maximum 25). Higher scores better |
| Pemberton Happiness Index (PHI) | 1 month | Pemberton Happiness Index (minimum 0 - maximum 110). Higher scores better |
| OMS WHO-QOL-BREF( WHOQOL-Group, 1998). | 2 weeks | Quality of life OMS (26 items, minimum 26 - maximum 130). Higher scores better |
Countries
Spain
Contacts
CONTACTPrincipal Investigator JCP JCP, PhD
CONTACTCo-IP (JS) JS J Soler
PRINCIPAL_INVESTIGATORPrincipal Investigator JCP Pascual, PhD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Outcome results
None listed