Sensory Hyper-Stimulation in Treating Depressive Symptoms: A Preliminary Open-Label Study on a Novel Network-Targeted Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale-17 (HDRS-17)
研究概览
简要总结
Major depressive disorder (MDD) is associated with dysfunction across large-scale brain networks and remains insufficiently responsive to existing treatments in many patients. While most therapeutic strategies target top-down cortical modulation, bottom-up sensory interventions remain relatively underexplored. The aim of the present study was to evaluate the safety and efficacy of a multisensory hyper-stimulation protocol in reducing depressive symptoms.
Fifteen adults with a moderate-to-severe depressive episode (HAMD-17 ≥17) received nine 20-minute sessions of multisensory stimulation combining auditory, thermal, and pressure stimuli (calibrated to approximately 60% of individual pain thresholds). Outcomes were assessed at baseline, mid-intervention (session 5), and post-intervention (session 9) using the Hamilton Depression Rating Scale (HAMD-17), Patient Health Questionnaire (PHQ-9), Rumination Response Scale (RRS), and Brief Resilience Scale (BRS). Within-subject changes were analyzed using Friedman tests with Bonferroni-corrected Wilcoxon post-hoc comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Major Depressive Disorder (MDD) according to DSM-5
- •baseline Hamilton Depression Rating Scale score (HAMD-17) > 17.
排除标准
- •Patients with Schizophrenia disorder and/or Active Psychosis.
- •Patients with serious physical morbidity (patents with unbalanced hypertension or diabetes).
- •Patients with ischemic heart disease.
- •Patients with chronic pain disorder or treatment regulary with pain killers (acamol etc) opioids or medical cannabis.
- •Active substance abuse (drugs or alcohol) two weeks before the study.
- •Sensory processing syndrome
- •Post traumatic stress disorder
研究组 & 干预措施
active arm
Fifteen adults with a moderate-to-severe depressive episode (HAMD-17 ≥17) received nine 20-minute sessions of multisensory stimulation combining auditory, thermal, and pressure stimuli (calibrated to approximately 60% of individual pain thresholds).
干预措施: sensory hyperstimulation (Other)
结局指标
主要结局
Hamilton Depression Rating Scale-17 (HDRS-17)
时间窗: 4 weeks
A questionnaire with results ranging from 0-53 Higher scores mean worse outcome
次要结局
- Brief State Rumination Inventory (BSRI)(4 weeks)