Ongoing Clinical Trials for Stress
Two clinical trials are currently investigating new approaches to managing stress and psychological distress. Both studies are taking place in Belgium and focus on using oxytocin nasal spray, either alone or combined with mindfulness training, to help reduce stress levels in adults experiencing psychological difficulties.
Clinical trial locations
- Belgium
Study on Oxytocin and Mindfulness Training for Reducing Stress in Adults with Psychological Distress
This trial explores how combining oxytocin nasal spray with mindfulness training might help adults manage stress more effectively. Oxytocin is a naturally occurring hormone in the body known for its role in social bonding and stress regulation. The study investigates whether using this hormone together with mindfulness exercises provides better results than either approach alone.
Who can participate:
- Adults between 18 and 50 years old
- People experiencing mild to severe stress symptoms, as measured by a specific stress assessment tool
- Individuals who can understand and communicate in Dutch well enough to complete study activities
- Those willing to provide written informed consent
Who cannot participate:
- Individuals experiencing severe psychological distress
- People outside the specified age range
- Those who belong to vulnerable populations requiring special protection
- Individuals currently participating in another clinical trial
- People with medical conditions that might interfere with the study results
What the study involves: Participants will receive oxytocin through a nasal spray and engage in mindfulness-based training sessions designed to help manage stress and improve emotional well-being. The study uses the product Oxytocine CD Pharma 40 IE/ml nasal spray. Throughout the trial, participants will complete various questionnaires to assess stress levels, mood, and quality of life. These include the Perceived Stress Scale, Depression Anxiety Stress Scale, Self-Compassion Scale, and State Adult Attachment Measure. The goal is to determine whether the combination therapy enhances stress management more effectively than either treatment alone.
Investigational approach: The trial tests two components. First, oxytocin, administered as a nasal spray, works by binding to specific receptors in the brain that influence social bonding and stress responses. Second, mindfulness training involves practices that help individuals focus on the present moment through meditation and breathing exercises, encouraging awareness of thoughts and feelings without judgment.
A Study of Oxytocin Nasal Spray to Reduce Psychological Stress in Women Who Have Recovered from Breast Cancer
This study examines whether oxytocin nasal spray can help reduce psychological stress in women who have completed breast cancer treatment. Many cancer survivors experience ongoing emotional difficulties after their treatment ends, and this research aims to determine if oxytocin can help improve their emotional well-being.
Who can participate:
- Women between 18 and 65 years old
- Those diagnosed with breast cancer (with or without a single metastasis, excluding brain metastasis)
- Individuals who completed chemotherapy and/or radiotherapy between 6 months and 6 years before joining
- Women currently receiving ongoing hormone therapy or immunotherapy can participate
- Those able to speak and understand Dutch sufficiently to complete study tasks
Who cannot participate:
- Men (this trial is specifically for women)
- Those currently undergoing active cancer treatment like chemotherapy or radiation
- People with a history of other cancer types besides breast cancer
- Individuals with severe psychiatric conditions
- Those currently using medications that could interact with oxytocin
- Pregnant or breastfeeding women
- People with uncontrolled high blood pressure or heart conditions
- Those who have had adverse reactions to oxytocin or similar medications previously
- Individuals with substance abuse or dependence within the past 6 months
What the study involves: Participants will receive either oxytocin nasal spray or a placebo (salt water solution) for up to 5 days. Throughout the study, they will complete various questionnaires about their stress levels, emotional state, sleep quality, and thinking abilities. These include the Perceived Stress Scale, Depression Anxiety Stress Scale, Cognitive Failure Questionnaire, Pittsburgh Sleep Quality Index, and quality of life assessments. Participants will also perform computer-based cognitive tests using the Amsterdam Cognition Scan to measure mental performance. The study runs from October 2025 to October 2027.
Investigational treatment: Oxytocin is being studied for its potential stress-reducing effects in breast cancer survivors. This represents a novel therapeutic approach beyond its traditional uses. The hormone works by binding to receptors in the brain, influencing emotional processing, stress response, and social behavior through complex neurological pathways. The trial investigates whether it can effectively modulate psychological distress and improve emotional well-being in women who have completed cancer treatment.
Summary
Both ongoing clinical trials focus on Belgium and explore the use of oxytocin nasal spray as a potential treatment for stress and psychological distress. The first study takes a combined approach, pairing oxytocin with mindfulness training to help adults aged 18-50 experiencing mild to severe stress. The second trial specifically targets women who have survived breast cancer, examining whether oxytocin alone can help reduce the psychological burden many cancer survivors face after treatment.
These studies represent innovative approaches to stress management, investigating whether a naturally occurring hormone can be used therapeutically to improve emotional well-being. Both trials require participants to be fluent in Dutch and involve careful monitoring through questionnaires and assessments. While the first study is open to adults experiencing general psychological distress, the second focuses specifically on the unique challenges faced by breast cancer survivors, reflecting different but complementary research goals in the field of stress management.
