2024-513482-39-00招募中2 期
Exploring the mechanistic link between the oxytocinergic system and mindfulness training
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- self-perceived emotional stress socres using the self-report Perceived stress scale (PSS) and the Depression Anxiety Stress Scale (DASS-21)
研究概览
简要总结
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. Change from baseline after oxytocin administration on: • Behavioral measurements of psychological distress • Neurophysiological measurements of stress
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Active use of psychotropic medication within 6 months prior to participation (including anti-depressants, anxiolytica, antipsychotica)
- •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
- •Participation in another clinical trial with IMP.
- •Active engagement in psychological treatment within 6 months prior to participation (with psychologist or psychiatrist).
- •Participant 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
- •Subjects who have had previous chronic treatment with oxytocin
- •Patient 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).
- •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.
- •Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. PraderWilli or Angelman syndrome
- •For women, being pregnant or breastfeeding, or planning to become pregnant.
结局指标
主要结局
self-perceived emotional stress socres using the self-report Perceived stress scale (PSS) and the Depression Anxiety Stress Scale (DASS-21)
self-perceived emotional stress socres using the self-report Perceived stress scale (PSS) and the Depression Anxiety Stress Scale (DASS-21)
次要结局
- Assessments of the following additional self-report questionnaires: State adult Attachment Measure (SAAM), Self-Compassion Scale-Short Form (SCS-SF), Pittsburg Sleepquality index (PSQI), Quality of life (WHO-5), Perseverative Thinking Questionnaire (PTQ), Three Facet Mindfulness Questionnaire -SF (TFMQ-SF), Profile of Mood State (POMS)
研究者
Kaat Alaerts
Scientific
UZ Leuven
研究点 (1)
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