Clinical trial NCT06589544: Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Quality of Life
Cognitive Impairment
Keywords: Depression
Cognitive functions
Quality of Life
Cancer
Virtual reality
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: University Hospital of Cagliari
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Hamilton Depression rating scale (HAM-D 17)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Dropout rates; Proportion of recruited participants among those considered eligible
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention)
measure: TMSens_Q
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention)
Secondary outcomes:
measure: EuroQol (EQ)-5D
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: SF-12
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Demoralization Scale (DS)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Post-Traumatic Embitterment Disorder Self-Rating Scale
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Brief Symptom Inventory (BSI)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Insomnia Severity Index (ISI)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Activities of Daily Living (ADL)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Psychosocial Adjustment to Illness (PAIS)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Toronto Alexithymia Scale 20-item (TAS-20)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Screen for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Trail Making Test
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Digit Span
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Stroop Test
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Frontal Assessment Battery (FAB)
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Rey's Word Test
timeFrame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
measure: Matrix test
timeFrame: T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1)
Other outcomes:
measure: Cost-effectiveness
timeFrame: T0 (0 months - baseline); T3 (6 months after T1-post intervention)
Locations:
city: Ferrara
country: Italy
facility: Health Trust, Ferrara
state: FE
city: Cagliari
country: Italy
facility: University Hospital of Cagliari
Study officials:
affiliation: Università degli Studi di Ferrara
name: Luigi Grassi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: