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Exploring the mechanistic link between the oxytocinergic system and mindfulness training
EU CTIS ID: 2024-513482-39-00
What this study is testing
To evaluate whether combinatory treatment approaches, pairing oxytocin administration to mindfulness-based training sessions can boost stress-regulatory effects in adults with heightened stress complaints, i.e., compared to administering each intervention as stand-alone. More specifically, change from baseline after oxytocin administration on behavioral measurements of psychological distress
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Must be between 18 and 50 years old at the time of signing the Informed Consent Form (ICF);
- Self-report to currently experience mild to severe stress symptoms (as assessed using the stress subscale of DASS-21: 15-25: mild to moderate ; 26-34+: severe to extremely severe range)
- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.
You likely can't join if
- Active use of psychotropic medication within 6 months prior to participation (including anti-depressants, anxiolytica, antipsychotica)
- Participants with a history of active epilepsy, defined as individuals experiencing seizures or requiring anticonvulsant therapy within the past 12 months, will be excluded from the study.
- Has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome).
- Participation in another clinical trial with IMP.
- Significant hearing or vision impairments (that cannot be corrected) that would interfere with the assessments.
- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Must be between 18 and 50 years old at the time of signing the Informed Consent Form (ICF);
- Self-report to currently experience mild to severe stress symptoms (as assessed using the stress subscale of DASS-21: 15-25: mild to moderate ; 26-34+: severe to extremely severe range)
- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.
- Active use of psychotropic medication within 6 months prior to participation (including anti-depressants, anxiolytica, antipsychotica)
- Participants with a history of active epilepsy, defined as individuals experiencing seizures or requiring anticonvulsant therapy within the past 12 months, will be excluded from the study.
- Has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome).
- Participation in another clinical trial with IMP.
- Significant hearing or vision impairments (that cannot be corrected) that would interfere with the assessments.
- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
- Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, and caudal anesthesia
- For women, being pregnant or breastfeeding, or planning to become pregnant.
- Active engagement in psychological treatment within 6 months prior to participation (with psychologist or psychiatrist).
- Has substantial experience with meditative practices (including but not limited to mindfulness, yoga, tai chi, or other similar practices) and meets any of the following criteria: a. Participant has participated in a multi-day meditation retreat or program during the past six months; b. Participant engages in meditative practices on a weekly basis or more frequently, for at least six consecutive weeks, within six month prior to the study.
- Has used oxytocin chronically within the past five years, either independently or as part of a study.
- Has a significant active medical condition including hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease which influence the metabolism of oxytocin (IMP).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.