Clinical trial · Interventional
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Cost-effectiveness of Transcranial Magnetic Stimulation and Virtual Reality Based Cognitive Remediation on Depressive Symptoms Among Cancer Patients: a Three-arm Randomized Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Impairment | — | UNRESOLVED | — |
| Depressive Symptoms | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) | Device | — | UNRESOLVED |
| Treatment as Usual (TAU) | Other | — | UNRESOLVED |
| Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Virtual Reality-based Cognitive Remediation (VR-COG)
- description
- Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as usual (TAU) The "VSail 3D" experimental protocol includes scenarios (virtual environments) dedicated to the sport of sailing. It is based on the software CEREBRUM-VELA (Idego-Promind, srl, Rome, Italy). Frequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 50 minutes.
- interventionNames
- Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)
- type
- EXPERIMENTAL
- label
- Repetitive transcranial magnetic stimulation (rTMS)
- description
- Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) rTMS group will receive active rTMS using the MagVenture MagPro X100 System (MagVenture A/S, Denmark) equipped with a MagVenture Cool-B65 A/P double-faced coil and a neuronavigation system (Localite GmbH, Sankt Augustin, Germany). Frequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 60 minutes.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSancassiani F, Murri MB, Madeddu C, Atzeni M, Kalcev G, Zaccagnino B, Olivetti AF, Azzolina D, Cruciata M, Nanni MG, Cossu G, Perra A, di Natale L, Primavera D, Tusconi M, Caruso R, Carta MG, Grassi L. Cost-Effectiveness of Transcranial Magnetic Stimulation and Virtual Reality-Based Cognitive Remediation for Depressive Symptoms among Cancer Patients: Protocol for a Three-Arm Randomized Controlled Trial. Clin Pract Epidemiol Ment Health. 2026 Mar 24;22:e17450179376750. doi: 10.2174/0117450179376750250925051532. eCollection 2026. PMID 42022442