Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intranasal Oxytocin (IN-OXT)

    Drug

    24 UI oxytocin intranasal

  • Intranasal Placebo

    Drug

    24 UI intranasal placebo

  • Self-Compassion Training (SCT)

    Behavioral

    SCT consists of a 5 sessions of Self-Compassions meditation training

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Self-compassion training (SCT) plus intranasal oxytocinExperimental treatment 2 interventions
Group B: Self-compassion training (SCT) plus intranasal placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Self Compassion Scale Short Form (SCS-SF)

Self-Compassion Scale (12 items, minimum 12-maximum 60). Higher scores worse

Time frame
1 month

Secondary outcomes

1

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

Time frame
1 month
2

Borderline Symptoms List-23 (BSL-23)

Self-reported Borderline Symptoms scale (minimum 0- maximum 92). Higher scores worse

Time frame
1 week
3

Satisfaction with life scale (SWLS)

Self-reported satisfaction with life scale (SWLS), well being (5 items, minimum 5 - maximum 25). Higher scores better

Time frame
1 month
4

Pemberton Happiness Index (PHI)

Pemberton Happiness Index (minimum 0 - maximum 110). Higher scores better

Time frame
1 month

Other outcomes

Sponsors and contacts

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