Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Recruiting · NCT06589544 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital of Ferrara
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- University Hospital of Cagliari - Cagliari, Italy
- Health Trust, Ferrara - Ferrara, FE, Italy