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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital of Ferrara

About this trial

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

Qualifiers

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

Disqualifiers

Current or prior hospitalization in the next 6 months

Planned surgery in the next 6 months

Suicidal ideation

Substance use

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University Hospital of Ferrara

Lead sponsor

University Hospital of Cagliari

Collaborator