Actively Recruiting
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Led by University Hospital of Ferrara · Updated on 2024-09-19
100
Participants Needed
2
Research Sites
175 weeks
Total Duration
On this page
Sponsors
U
University Hospital of Ferrara
Lead Sponsor
U
University Hospital of Cagliari
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of oncological disease in the last 5 years
- Diagnosis of Major Depressive Disorder without psychotic symptoms according to DSM-5
- Hamilton Rating Scale for Depression (HAM-D-17) score of 14 or higher
- Age 18 years or older
- Non-advanced cancer stage with Karnofsky Performance Status greater than 80
You will not qualify if you...
- Current or planned hospitalization within the next 6 months
- Planned surgery within the next 6 months
- Presence of suicidal thoughts
- Substance use
- History of significant head trauma, neurological disorders, or intellectual disabilities
- Recurrent seizures from head trauma or conditions lowering seizure threshold
- Use of medications that increase epilepsy risk (e.g., antipsychotics, tricyclics, theophylline)
- Glaucoma, retinal detachment, or serious vision problems preventing virtual reality use
- Severe difficulty walking independently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Health Trust, Ferrara
Ferrara, FE, Italy, 44124
Actively Recruiting
2
University Hospital of Cagliari
Cagliari, Italy, 09124
Actively Recruiting
Research Team
M
Martino Belvederi Murri, MD
CONTACT
B
Barbara Zaccagnino, PsyD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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