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

University Hospital of Ferrara

Status: Enrolling

Conditions: Depressive Symptoms; Cognitive Impairment; Quality of Life

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU); Other: Treatment as Usual (TAU); Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06589544

199/2023/Disp/AUSLFe PNRR onco

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Virtual Reality-based Cognitive Remediation (VR-COG)

Experimental group

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.

Treatment:

Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)

Repetitive transcranial magnetic stimulation (rTMS)

Experimental group

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)

Treatment as Usual (TAU)

Active Comparator group

Description:

Treatment as Usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https://www.aiom.it), includes an initial psychiatric visit and eventual pharmacological therapy with psychiatric follow-up plus psychological counseling. Frequency: 12 weeks. Each counseling session lasts 45-50 minutes, and will be conducted on a monthly basis.

Treatment:

Other: Treatment as Usual (TAU)