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Controlled and randomized clinical trial to evaluate the efficacy of the combination of oxytocin plus Self-Compassion Training (SCT) in patients with Borderline Personality Disorder (BPD).

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515589-15-00
Acronym
IIBSP-OXI-2022-124
Enrollment
80
Registered
2024-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder.

Brief summary

Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).

Detailed description

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

Interventions

DRUGDenominación Común Internacional (DCI): placebo (Suero fisiológico) Denominación Química: Cloruro Sódico 0.9% Forma molecular: NaCl Composición cuali y cuantitativa: 9mg/ml Forma farmacéutica: solución para pulverización nasal Dosis y vía de administración: 0.6ml/ día (6 pulverizaciones ) vía intranasa
DRUGSyntocinon 40 U.I./ml Solução para pulverização nasal

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).—

Secondary

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

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026