Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital of Ferrara
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current or prior hospitalization in the next 6 months
Planned surgery in the next 6 months
Suicidal ideation
Substance use
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)
DeviceThe "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 individual should try to do during his day. 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).
Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)
DeviceActive 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 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).
Treatment as Usual (TAU)
Other interventionTreatment 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).
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Virtual Reality-based Cognitive Remediation (VR-COG)Experimental treatment 1 intervention
Group B: Repetitive transcranial magnetic stimulation (rTMS)Experimental treatment 1 intervention
Group C: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hamilton Depression rating scale (HAM-D 17)
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.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)2
Dropout rates; Proportion of recruited participants among those considered eligible
Feasibility will be assessed based on tolerability (dropout rates) and acceptability (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)3
Simulator Sickness Questionnaire (SSQ)
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.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention)4
TMSens_Q
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.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention)Secondary outcomes
1
EuroQol (EQ)-5D
It is self-report questionnaire to assess quality of life and heath status according to five dimensions.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)2
SF-12
It is a self-report questionnaire to assess quality of life considering two dimensions, about physical health and mental health.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)3
Demoralization Scale (DS)
It is a 24-item self-administered questionnaire with four subscales: discouragement, loss of meaning/purpose, dysphoria, sense of failure.
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)4
Post-Traumatic Embitterment Disorder Self-Rating Scale
It is a rating scale to assess embitterment reactions to negative life events
Time frame
T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)Other outcomes
1
Cost-effectiveness
The cost effectiveness will be computed as the ratio of total costs divided by the mean improvements of quality of life across interventions (TAU, TAU+rTMS, TAU+VRCOG). Total costs will include the costs of the healthcare consultations (visits in the TAU condition), psychotropic drugs, equipment and staff. Total costs will be computed as the sum of these costs of each intervention, divided by the number of patients. Quality of life improvements will be computed as the difference between baseline (T0) vs endpoint (T3) quality of life.
Time frame
T0 (0 months - baseline); T3 (6 months after T1-post intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Ferrara
Lead sponsor
University Hospital of Cagliari
Collaborator
Source ClinicalTrials.gov