Sensory Hyperstimulation for Treating Depression

NCT07800663 | Completed

• 1 other identifier: Yehuda05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-17 (HDRS-17)

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

  4 weeks

Secondary Outcomes (1)

• Brief State Rumination Inventory (BSRI)

  4 weeks

Study Arms (1)

active arm

EXPERIMENTAL

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).

Other: sensory hyperstimulation

Interventions

sensory hyperstimulation OTHER

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

active arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Major Depressive Disorder (MDD) according to DSM-5
• age ≥18
• baseline Hamilton Depression Rating Scale score (HAMD-17) \> 17.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label study

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: September 2, 2026
• Study Start: April 18, 2021
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

IL (1)