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

Официальное название

Cost-effectiveness of Transcranial Magnetic Stimulation and Virtual Reality Based Cognitive Remediation on Depressive Symptoms Among Cancer Patients: a Three-arm Randomized Clinical Trial.

Обзор

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.

Вмешательства

• Устройство 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 individu
• Устройство 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 ai
• Другое 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).

Первичные конечные точки

• Hamilton Depression rating scale (HAM-D 17) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Dropout rates; Proportion of recruited participants among those considered eligible [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Simulator Sickness Questionnaire (SSQ) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention)]
• TMSens_Q [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention)]

Вторичные конечные точки (12)

• EuroQol (EQ)-5D [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• SF-12 [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Demoralization Scale (DS) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Post-Traumatic Embitterment Disorder Self-Rating Scale [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Brief Symptom Inventory (BSI) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Insomnia Severity Index (ISI) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Activities of Daily Living (ADL) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Psychosocial Adjustment to Illness (PAIS) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Toronto Alexithymia Scale 20-item (TAS-20) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Screen for Cognitive Impairment in Psychiatry (SCIP) [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
• Trail Making Test [Срок оценки: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Италия · 2 центра

• Health Trust, Ferrara — Ferrara
• University Hospital of Cagliari — Cagliari

Публикации

• Sancassiani F, Murri MB, Madeddu C, Atzeni M, Kalcev G, Zaccagnino B, Olivetti AF, Azzolina D, Cruciata M, Nanni MG, Cossu G, Perra A, di Natale L, Primavera D, Tusconi M, Caruso R, Carta MG, Grassi L. Cost-Effectiveness of Transcranial Magnetic Stimulation and Virtual Reality-Based Cognitive Remediation for Depressive Symptoms among Cancer Patients: Protocol for a Three-Arm Randomized Controlled PMID 42022442

Идентификаторы

NCT: NCT06589544 · 199/2023/Disp/AUSLFe PNRR onco

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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