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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 21, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Depressive SymptomsQuality of LifeCognitive Impairment
Interventions
DEVICE

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

"The CEREBRUM-VELA virtual reality software is made up of exercises designed to train different cognitive functions (i.e.: executive functions, motor ability, language). The different degrees of difficulty are designed to adapt to the user's functional diagnosis. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback and suggestions of practical homework that the individual should try to do during his day.~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 aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions)."

DEVICE

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

"Active rTMS stimulation will be delivered at 90% of the resting Motor Threshold (rMT), adjusted for the depth of the fcMRI-identified target. Personalized targets created for each individual will be located at various cortical depths. For safety reasons, the stimulation intensity will never exceed 120% of the rTMS.~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 aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions)."

OTHER

Treatment as Usual (TAU)

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 aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions).

Trial Locations (2)

44124

RECRUITING

Health Trust, Ferrara, Ferrara

09124

RECRUITING

University Hospital of Cagliari, Cagliari

All Listed Sponsors
collaborator

University Hospital of Cagliari

UNKNOWN

lead

University Hospital of Ferrara

OTHER