NCT06589544 Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
| NCT ID | NCT06589544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of Ferrara |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite its significant impact on individuals and healthcare systems, substantial gaps remain in the clinical and rehabilitative management of depression in oncology patients. Depression in cancer patients is often under-recognized and untreated, and screening tools and structured healthcare pathways are lacking. Even when depression is identified in oncology patients, evidence of effective treatments is limited. There are no specific guidelines for psychotropic drug use in cancer patients, and antidepressant efficacy is uncertain despite their frequent use. Emerging strategies like transcranial magnetic stimulation and cognitive rehabilitation show promising findings. However, the cost-effectiveness of therapeutic strategies is understudied. Repetitive transcranial magnetic stimulation (rTMS) is already used for the treatment and relapse prevention of depression both as monotherapy and as an add-on to antidepressant pharmacotherapy, and it appears effective in improving cognitive performance. However, it has not yet been applied to treat depressive disorders in oncology patients. Virtual reality-based cognitive behavioral intervention (VR-COG) is designed to improve cognitive functioning, a central feature of depression in oncological conditions. VR-COG enhances learning and skill acquisition with better ecological efficiency than traditional cognitive remediation programs. VR approaches are well-received by oncology patients and show promise in reducing anxiety and depressive symptoms. The trial aims to evaluate the effectiveness of highly specialized, nonpharmacological interventions on depressive symptoms and quality of life in oncology patients. Specifically, repetitive Transcranial Magnetic Stimulation (rTMS) and Virtual Reality-based Cognitive Remediation (VR-COG) will be analyzed, alongside standard Treatment as Usual (TAU), in comparison to TAU alone. This trial also aims at evaluate cognitive functioning, depression-related conditions and the cost-effectiveness of the interventions under study.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of oncological disease in the last 5 years * Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria * 17-item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14) * Age: 18 years or older * Oncological disease in a non-advanced stage (Karnofsky Performance Status \> 80) Exclusion Criteria: * Current or prior hospitalization in the next 6 months * Planned surgery in the next 6 months * Suicidal ideation * Substance use * History of significant head trauma, neurological disorders, intellectual deficits * Recurrent seizures resulting from head trauma or conditions lowering seizure threshold * Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline) * Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology * Severe problems with autonomous ambulation
Contact & Investigator
Luigi Grassi, MD, PhD
PRINCIPAL INVESTIGATOR
Università degli Studi di Ferrara
Frequently Asked Questions
Who can join the NCT06589544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06589544 currently recruiting?
Yes, NCT06589544 is actively recruiting participants. Contact the research team at martino.belvederimurri@unife.it for enrollment information.
Where is the NCT06589544 trial being conducted?
This trial is being conducted at Ferrara, Italy, Cagliari, Italy.
Who is sponsoring the NCT06589544 clinical trial?
NCT06589544 is sponsored by University Hospital of Ferrara. The principal investigator is Luigi Grassi, MD, PhD at Università degli Studi di Ferrara. The trial plans to enroll 100 participants.