Cost-effectiveness of Transcranial Magnetic Stimulation and Virtual Reality Based Cognitive Remediation on Depressive Symptoms Among Cancer Patients: a Three-arm Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hamilton Depression rating scale (HAM-D 17)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Virtual Reality-based Cognitive Remediation (VR-COG)
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.
干预措施: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU) (Device)
Repetitive transcranial magnetic stimulation (rTMS)
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.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) (Device)
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 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.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Hamilton Depression rating scale (HAM-D 17)
时间窗: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
The Ham-D is the most widely used clinician-administered depression assessment scale.The original version contains 17 items pertaining to symptoms of depression experienced over the past week.
Dropout rates; Proportion of recruited participants among those considered eligible
时间窗: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Feasibility will be assessed based on tolerability (dropout rates) and acceptability (proportion of recruited participants among those considered eligible).
Simulator Sickness Questionnaire (SSQ)
时间窗: T0 (0 months - baseline); T1 (3 months - post intervention)
Feasibility will be assessed based on side effects through Simulator Sickness Questionnaire (SSQ) self-report questionnaire that evaluates the frequency of unwanted effects due to virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items.
TMSens_Q
时间窗: T0 (0 months - baseline); T1 (3 months - post intervention)
It was developed to report secondary effects following rTMS application. The use of the structured rTMS questionnaire will help to monitor the safety of rTMS.
次要结局
- EuroQol (EQ)-5D(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- SF-12(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Demoralization Scale (DS)(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(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Brief Symptom Inventory (BSI)(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Insomnia Severity Index (ISI)(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)(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Activities of Daily Living (ADL)(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Psychosocial Adjustment to Illness (PAIS)(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)(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)(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Trail Making Test(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Digit Span(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Stroop Test(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Frontal Assessment Battery (FAB)(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Rey's Word Test(T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1))
- Matrix test(T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1))