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Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS

RecruitingNAAges 18 Years - 100 YearsAllUniversity Hospital of Ferrara
NCT06589544 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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
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What it tests

  • Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)
  • Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)
  • Treatment as Usual (TAU)
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Where

2 sites
Health Trust, Ferrara
Ferrara, Italy
University Hospital of Cagliari
Cagliari, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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