Study on Oxytocin and Self-Compassion Training for Patients with Borderline Personality Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for individuals with Borderline Personality Disorder (BPD). The treatment being tested combines a nasal spray containing oxytocin with a program called Self-Compassion Training (SCT). Oxytocin is a hormone that can influence social behaviors and emotions, and it is administered through a nasal spray in this study. The purpose of the study is to evaluate how this combination might help in the therapeutic process for people with BPD.

Participants in the study will receive either the oxytocin nasal spray or a placebo, which is a substance with no active medication. The study will involve regular sessions of Self-Compassion Training, which is designed to help individuals develop a kinder and more understanding attitude towards themselves. The study will take place over a period of time, during which participants will be monitored to assess the effects of the treatment on their symptoms and overall well-being.

The trial aims to explore whether the combination of oxytocin and SCT can improve self-compassion and reduce symptoms associated with BPD. Participants will be evaluated using various measures, including their levels of self-compassion, self-criticism, and overall satisfaction with life. The study hopes to provide insights into new ways of supporting individuals with BPD in their therapeutic journey.

1 joining the study

Upon joining the study, participation is confirmed based on a diagnosis of Borderline Personality Disorder (BPD) through specific interviews. Eligibility is determined by age, stability of current medication, and previous treatment history.

2 initial assessment

An initial assessment is conducted to evaluate self-compassion and self-criticism levels using standardized scales. This helps establish a baseline for the study.

3 medication administration

Participants receive oxytocin administered as a nasal spray solution. The dosage is 40 U.I./ml, and it is used through inhalation. The frequency and duration of administration are determined by the study protocol.

4 self-compassion training

Participants engage in Self-Compassion Training (SCT) sessions. These sessions are designed to enhance therapeutic outcomes and are conducted alongside the medication administration.

5 ongoing assessments

Throughout the study, regular assessments are conducted to measure self-compassion, self-criticism, symptomatology of BPD, rage, life satisfaction, well-being, and functionality. These assessments use various scales and questionnaires.

6 completion of the study

The study is estimated to conclude by June 2025. Upon completion, final assessments are conducted to evaluate the overall impact of the treatment on participants.

Who Can Join the Study?

Must have a diagnosis of Borderline Personality Disorder (BPD). This is confirmed through two specific interviews designed to assess personality disorders.
Must be between 18 and 50 years old.
Must have a stable medication treatment during the study period.
Must have received previous treatment for BPD using a therapy called Dialectical Behavioral Therapy (DBT) or training in DBT skills. DBT is a type of therapy that helps people manage their emotions and improve relationships.
Must have high levels of self-criticism. This is measured by a specific score on a test that assesses feelings of inadequacy.

Who Cannot Join the Study?

Individuals who are not diagnosed with Borderline Personality Disorder cannot participate. This is a mental health condition that affects how a person thinks and feels about themselves and others.
Participants must be within a specific age range, typically adults, to be eligible.
Both males and females are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population, such as those unable to give informed consent, are not included in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hxatuoyx Ds Lu Sojce Clhg I Sner Pbt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.01.2023

Trial locations

Investigated drugs:

Oxytocin

Oxytocin is a hormone that is often associated with social bonding and emotional regulation. In this clinical trial, it is administered intranasally to help improve emotional and social functioning in patients with Borderline Personality Disorder (BPD). The goal is to see if oxytocin can enhance the effects of therapy by making patients more receptive to treatment.

Self-Compassion Training (SCT) is a therapeutic approach that teaches individuals to be kind and understanding towards themselves, especially during difficult times. In this trial, SCT is used to help patients with BPD develop healthier emotional responses and improve their overall mental well-being. The training aims to reduce self-criticism and increase self-acceptance, which can be particularly beneficial for individuals with BPD.

Investigated diseases:

Borderline personality disorder

Borderline Personality Disorder – This is a mental health disorder characterized by pervasive instability in moods, behavior, self-image, and functioning. Individuals with this disorder often experience intense episodes of anger, depression, and anxiety that may last from a few hours to days. They may have difficulty maintaining stable relationships and often have a distorted self-image. Impulsive behaviors, such as spending sprees, unsafe sex, substance abuse, reckless driving, and binge eating, are common. People with Borderline Personality Disorder may also experience feelings of emptiness, fear of abandonment, and difficulty trusting others. Emotional swings and a tendency to view things in extremes, such as all good or all bad, are also typical.

Trial ID:

2024-515589-15-00

Protocol code:

IIBSP-OXI-2022-124

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Oxytocin and Self-Compassion Training for Patients with Borderline Personality Disorder

What is this study about?

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