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Study on Oxytocin and Mindfulness Training for Reducing Stress in Adults with Psychological Distress

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the combination of the hormone oxytocin and mindfulness training can help reduce stress in adults experiencing psychological distress. Psychological distress refers to feelings of anxiety, depression, or stress that can affect daily life. The study will use a nasal spray containing oxytocin, a naturally occurring hormone known for its role in social bonding and stress regulation.

The purpose of the study is to see if using oxytocin together with mindfulness training is more effective in managing stress than using either approach alone. Mindfulness training involves exercises that help individuals focus on the present moment, which can improve emotional well-being. Participants will receive either the oxytocin nasal spray or a placebo during mindfulness sessions to compare the effects on stress levels.

Throughout the study, participants will be asked to complete various questionnaires to assess their levels of stress, mood, and quality of life. These assessments will help researchers understand the impact of the treatment on psychological distress. The study aims to provide insights into how combining oxytocin with mindfulness training might enhance stress management in individuals with heightened stress complaints.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Participants will undergo an initial assessment to evaluate their current level of psychological distress. This will involve completing self-report questionnaires such as the Perceived Stress Scale (PSS) and the Depression Anxiety Stress Scale (DASS-21).

  2. Step 2

    Oxytocin administration

    Participants will receive oxytocin through a nasal spray. The product used is Oxytocine CD Pharma 40 IE/ml nasal spray, solution. The administration is intranasal, meaning it is delivered through the nose.

  3. Step 3

    Mindfulness training sessions

    Participants will engage in mindfulness-based training sessions. These sessions are designed to help manage stress and improve emotional well-being.

  4. Step 4

    Combined treatment evaluation

    The study aims to evaluate the effects of combining oxytocin administration with mindfulness training. This will be compared to the effects of each intervention when administered alone.

  5. Step 5

    Follow-up assessments

    Participants will complete follow-up assessments to measure changes in stress levels and emotional well-being. This will include repeating the initial self-report questionnaires and additional assessments such as the State Adult Attachment Measure (SAAM) and the Self-Compassion Scale-Short Form (SCS-SF).

Who can join the trial?

4 criteria

  • The participant must give their voluntary written informed consent before any screening procedures. This means they agree to join the study after understanding what it involves.
  • The participant must be between 18 and 50 years old when they sign the Informed Consent Form.
  • The participant must report experiencing mild to severe stress symptoms. This is measured using a tool called the DASS-21, which checks stress levels. Scores between 15-25 indicate mild to moderate stress, and scores of 26 or higher indicate severe to extremely severe stress.
  • The participant must be able to understand and use the Dutch language well enough to complete study tasks, but they do not need to be native speakers.

Who cannot join the trial?

7 criteria

  • Individuals with severe psychological distress complaints, which means experiencing intense emotional discomfort or stress.
  • Participants who are not within the age range specified for the study.
  • Individuals who are part of a vulnerable population, meaning those who might need special protection or care.
  • Participants who do not meet the specific health or medical conditions required for the study.
  • Individuals who are not able to follow the study procedures or instructions.
  • Participants who are currently involved in another clinical trial.
  • Individuals with any medical condition that the study team believes could interfere with the study results.
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Investigated drugs

  • Oxytocin

    is a hormone that plays a role in social bonding, stress regulation, and emotional responses. In this clinical trial, oxytocin is administered to participants to see if it can help reduce stress when combined with mindfulness training. The goal is to determine if this combination is more effective in managing stress than using either oxytocin or mindfulness training alone.

  • Mindfulness Training

    involves practices that help individuals focus on the present moment, often through meditation and breathing exercises. This training aims to improve mental well-being and reduce stress by encouraging participants to be more aware of their thoughts and feelings without judgment. In this trial, mindfulness training is paired with oxytocin administration to assess its effectiveness in enhancing stress regulation.

What is already known about the treatment

Oxytocin – Oxytocin is typically administered as a nasal spray, allowing for easy absorption through the nasal mucosa. It is currently being studied in clinical trials to assess its potential benefits in reducing psychological distress and stress-related symptoms. The main therapeutic indication for oxytocin in this context is to enhance stress regulation, particularly when combined with mindfulness training. At the molecular level, oxytocin works by binding to oxytocin receptors in the brain, which can influence social bonding and stress responses. It is classified as a neuropeptide hormone, known for its role in social interactions and emotional regulation.

Investigated diseases

Psychological Distress – Psychological distress refers to a state of emotional suffering characterized by symptoms such as anxiety, depression, and stress. It often arises in response to challenging life events or situations and can affect a person's ability to function in daily life. Individuals experiencing psychological distress may feel overwhelmed, have difficulty concentrating, and experience changes in sleep or appetite. The condition can vary in intensity and duration, with some people experiencing temporary distress while others may face more persistent symptoms. Psychological distress is not a specific mental disorder but rather a general term that encompasses a range of emotional and psychological challenges. It is important to recognize and address these feelings to prevent them from impacting overall well-being.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513482-39-00Estimated enrolment140 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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