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Completed

NCT Number: NCT07800663

Sensory Hyperstimulation for Treating Depression

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.

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv University

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sensory hyperstimulation

Other

nine 20-minute sessions of multisensory stimulation combining auditory, thermal, and pressure stimuli (calibrated to approximately 60% of individual pain thresholds)

Primary outcomes

  1. Hamilton Depression Rating Scale-17 (HDRS-17)

    Time frame: 4 weeks

    A questionnaire with results ranging from 0-53 Higher scores mean worse outcome

Secondary outcomes

  1. Brief State Rumination Inventory (BSRI)

    Time frame: 4 weeks

    An 8 items questionnaire with results ranging from 0-80 The higher the results the worse the outcome

Sponsors and collaborators

Lead sponsor

Shalvata Mental Health Center

Other

Registry information

Official study title

Sensory Hyper-Stimulation in Treating Depressive Symptoms: A Preliminary Open-Label Study on a Novel Network-Targeted Intervention

Acronym: HSS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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