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Completed
NCT07800663
Sensory Hyperstimulation for Treating Depression
Conditions: Depressive Disorder
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Shalvata Mental Health Center
Location: Tel-Aviv University Tel Aviv
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* diagnosis of Major Depressive Disorder (MDD) according to DSM-5
* age ≥18
* baseline Hamilton Depression Rating Scale score (HAMD-17) \> 17.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07800663). StuddyBuddy aggregates publicly available trial information.