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

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

NCT ID: NCT06589544

Condition: Depressive Symptoms
Quality of Life
Cognitive Impairment

Conditions: Official terms:
Depression

Conditions: Keywords:
Depression
Cognitive functions
Quality of Life
Cancer
Virtual reality
Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)
Description: 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).
Arm group label: Virtual Reality-based Cognitive Remediation (VR-COG)

Intervention type: Device
Intervention name: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)
Description: 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).
Arm group label: Repetitive transcranial magnetic stimulation (rTMS)

Intervention type: Other
Intervention name: Treatment as Usual (TAU)
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 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).
Arm group label: Treatment as Usual (TAU)

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: Health Trust, Ferrara

Address:
City: Ferrara
Zip: 44124
Country: Italy

Status: Recruiting

Contact:
Last name: Martino Belvederi Murri, MD

Phone: 0039 3335248720
Email: martino.belvederimurri@unife.it

Contact backup:
Last name: Barbara Zaccagnino, PsyD

Phone: 0039 3288657355
Email: barbara.zaccagnino@edu.unife.it

Facility:
Name: University Hospital of Cagliari

Address:
City: Cagliari
Zip: 09124
Country: Italy

Status: Recruiting

Contact:
Last name: Federica Sancassiani, PsyD, PhD

Phone: 0039 3493119215
Email: federica.sancassiani@unica.it

Start date: August 21, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: University Hospital of Ferrara
Agency class: Other

Collaborator:
Agency: University Hospital of Cagliari
Agency class: Other

Source: University Hospital of Ferrara

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06589544