Depressive DisorderHSSNCT07800663
Sensory Hyperstimulation for Treating Depression
A study testing sensory hyperstimulation in people with Depressive Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- sensory hyperstimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Apr 2021to 18 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Major Depressive Disorder (MDD) according to DSM-5
- age ≥18
- baseline Hamilton Depression Rating Scale score (HAMD-17) > 17.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Hyper-Stimulation in Treating Depressive Symptoms: A Preliminary Open-Label Study on a Novel Network-Targeted Intervention
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
- Being tested
- sensory hyperstimulation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory hyperstimulationOther
nine 20-minute sessions of multisensory stimulation combining auditory, thermal, and pressure stimuli (calibrated to approximately 60% of individual pain thresholds)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: sensory hyperstimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale-17 (HDRS-17)
A questionnaire with results ranging from 0-53 Higher scores mean worse outcome
Measured: 4 weeks
Secondary outcomes (1)
Brief State Rumination Inventory (BSRI)
An 8 items questionnaire with results ranging from 0-80 The higher the results the worse the outcome
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start18 Apr 2021
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800663
- Sponsor's protocol ID
- Yehuda05
- Acronym
- HSS
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Hyper-Stimulation in Treating Depressive Symptoms: A Preliminary Open-Label Study on a Novel Network-Targeted Intervention
- ClinicalTrials.gov ID
- NCT07800663
- Acronym / sponsor ID
- HSS / Yehuda05
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label study
| Arm | Type | Receives |
|---|---|---|
| active arm | Experimental | Other: sensory hyperstimulationFifteen 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of Major Depressive Disorder (MDD) according to DSM-5
- age ≥18
- baseline Hamilton Depression Rating Scale score (HAMD-17) > 17.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensory hyperstimulationnine 20-minute sessions of multisensory stimulation combining auditory, thermal, and pressure stimuli (calibrated to approximately 60% of individual pain thresholds) | Other | active arm |
Primary outcome
Hamilton Depression Rating Scale-17 (HDRS-17)
Time frame: 4 weeks
A questionnaire with results ranging from 0-53 Higher scores mean worse outcome
1 secondary outcome
Brief State Rumination Inventory (BSRI)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Depressive Disorder
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory hyperstimulation in people with Depressive Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale-17 (HDRS-17) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.