Depressive SymptomsINCEPTNCT06589544
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
A study testing Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) and Treatment as Usual (TAU) in people with Depressive Symptoms and Quality of Life, run by University Hospital of Ferrara at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depressive Symptoms, Quality of Life, Cognitive Impairment
- What is being tested?
- Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) and Treatment as Usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 21 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
University Hospital of Cagliari
Cagliari, 09124
Federica Sancassiani, PsyD, PhD, 0039 3493119215, federica.sancassiani@unica.it
- Recruiting
Health Trust, Ferrara
Ferrara, FE, 44124
Martino Belvederi Murri, MD, 0039 3335248720, martino.belvederimurri@unife.it
Barbara Zaccagnino, PsyD, 0039 3288657355, barbara.zaccagnino@edu.unife.it
About this study
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.
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.
Read more
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
- Depressive Symptoms, Quality of Life, Cognitive Impairment
- Being tested
- Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU), Treatment as Usual (TAU)
- Keywords
- Depression, Cognitive functions, Quality of Life, Cancer, Virtual reality, Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Depression, Cognitive Dysfunction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)Device
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 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)Device
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 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) 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).
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-based Cognitive Remediation (VR-COG) | Experimental | 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. Receives: Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU) |
| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | 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. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) |
| Treatment as Usual (TAU) | Active comparator | 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Feasibility will be assessed based on tolerability (dropout rates) and acceptability (proportion of recruited participants among those considered eligible).
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
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.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention)
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.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention)
Secondary outcomes (17)
EuroQol (EQ)-5D
It is self-report questionnaire to assess quality of life and heath status according to five dimensions.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
SF-12
It is a self-report questionnaire to assess quality of life considering two dimensions, about physical health and mental health.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Demoralization Scale (DS)
It is a 24-item self-administered questionnaire with four subscales: discouragement, loss of meaning/purpose, dysphoria, sense of failure.
Measured: 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
It is a rating scale to assess embitterment reactions to negative life events
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Brief Symptom Inventory (BSI)
Il is a questionnaire to evaluate symptoms of psychological distress
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Insomnia Severity Index (ISI)
It is a tool to assess the severity of daytime and nighttime components of insomnia.
Measured: 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)
It is a scale consisting of 18 items to assess four areas of circadian rhythm difficulties: sleep, activity, social rhythms, and eating patterns.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Activities of Daily Living (ADL)
It is an instrument to assess disability levels.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Psychosocial Adjustment to Illness (PAIS)
I is a self-report instrument to assess seven dimensions about disability and quality of life.
Measured: 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)
It is a self-report questionnaire to assess alexithymia.
Measured: 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)
It is an instrument to assess cognitive deficit according to five subscales: immediate memory, working memory, phonemic verbal fluency, delayed memory, and psychomotor speed.
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Trail Making Test
Preliminary measures of effectiveness on executive function
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Digit Span
Preliminary measures of effectiveness on memory
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Stroop Test
Preliminary measures of effectiveness on executive function
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Frontal Assessment Battery (FAB)
Preliminary measures of effectiveness on executive function
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Rey's Word Test
Preliminary measures of effectiveness on memory
Measured: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Matrix test
Preliminary measure of effectiveness on selective attention.
Measured: T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cagliari
- Responsible party
- Sponsor
- Investigators
- Luigi Grassi, MD, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589544
- Sponsor's protocol ID
- 199/2023/Disp/AUSLFe PNRR onco
- Acronym
- INCEPT
- Status last verified
- Jun 2024
- First submitted
- 20 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Trial. Clin Pract Epidemiol Ment Health. 2026 Mar 24;22:e17450179376750. doi: 10.2174/0117450179376750250925051532. eCollection 2026.
PubMed 42022442
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06589544
- Acronym / sponsor ID
- INCEPT / 199/2023/Disp/AUSLFe PNRR onco
- Conditions
- Depressive Symptoms, Quality of Life, Cognitive Impairment
- Keywords
- Depression, Cognitive functions, Quality of Life, Cancer, Virtual reality, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- University Hospital of Cagliari
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-based Cognitive Remediation (VR-COG) | Experimental | Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)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. |
| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)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. |
| Treatment as Usual (TAU) | Active comparator | 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 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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). | Device | Virtual Reality-based Cognitive Remediation (VR-COG) |
| 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 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). | Device | Repetitive transcranial magnetic stimulation (rTMS) |
| 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). | Other | Treatment as Usual (TAU) |
Primary outcome
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)
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
Time frame: 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)
Time frame: 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
Time frame: 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.
17 secondary outcomes
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)
Digit Span
Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Stroop Test
Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Frontal Assessment Battery (FAB)
Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Rey's Word Test
Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)
Matrix test
Time frame: T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42022442Sancassiani 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 Trial. Clin Pract Epidemiol Ment Health. 2026 Mar 24;22:e17450179376750. doi: 10.2174/0117450179376750250925051532. eCollection 2026.
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Grassi, MD, PhD principal investigator
Università degli Studi di Ferrara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) and Treatment as Usual (TAU) in people with Depressive Symptoms and Quality of Life, run by University Hospital of Ferrara at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martino Belvederi Murri, MD (00393335248720, martino.belvederimurri@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.