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Recruiting NCT06589544

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

No phase Interventional Depressive Symptoms Quality of Life Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU), Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Depressive Symptoms, Quality of Life, Cognitive Impairment. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 individu
  • 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 ai
  • 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).

Primary outcome measures

  • Hamilton Depression rating scale (HAM-D 17) [Time frame: 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 [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Simulator Sickness Questionnaire (SSQ) [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention)]
  • TMSens_Q [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention)]
Secondary outcome measures (12)
  • EuroQol (EQ)-5D [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • SF-12 [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Demoralization Scale (DS) [Time frame: 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 [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Brief Symptom Inventory (BSI) [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Insomnia Severity Index (ISI) [Time frame: 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) [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Activities of Daily Living (ADL) [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Psychosocial Adjustment to Illness (PAIS) [Time frame: 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) [Time frame: 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) [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]
  • Trail Making Test [Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Italy · 2 centers
  • Health Trust, Ferrara — Ferrara
  • University Hospital of Cagliari — Cagliari

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗