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NCT Number: NCT06589544

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

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depression Mental Disorders Neoplasms Neurocognitive Disorders Quality of Life

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Trust, Ferrara, Ferrara, FE, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other

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 outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. EuroQol (EQ)-5D

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    It is self-report questionnaire to assess quality of life and heath status according to five dimensions.

  2. SF-12

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    It is a self-report questionnaire to assess quality of life considering two dimensions, about physical health and mental health.

  3. Demoralization Scale (DS)

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    It is a 24-item self-administered questionnaire with four subscales: discouragement, loss of meaning/purpose, dysphoria, sense of failure.

  4. 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)

    It is a rating scale to assess embitterment reactions to negative life events

  5. 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)

    Il is a questionnaire to evaluate symptoms of psychological distress

  6. 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)

    It is a tool to assess the severity of daytime and nighttime components of insomnia.

  7. 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)

    It is a scale consisting of 18 items to assess four areas of circadian rhythm difficulties: sleep, activity, social rhythms, and eating patterns.

  8. 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)

    It is an instrument to assess disability levels.

  9. 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)

    I is a self-report instrument to assess seven dimensions about disability and quality of life.

  10. 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)

    It is a self-report questionnaire to assess alexithymia.

  11. 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)

    It is an instrument to assess cognitive deficit according to five subscales: immediate memory, working memory, phonemic verbal fluency, delayed memory, and psychomotor speed.

  12. Trail Making Test

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    Preliminary measures of effectiveness on executive function

  13. Digit Span

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    Preliminary measures of effectiveness on memory

  14. Stroop Test

    Time frame: T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

    Preliminary measures of effectiveness on executive function

  15. 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)

    Preliminary measures of effectiveness on executive function

  16. 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)

    Preliminary measures of effectiveness on memory

  17. Matrix test

    Time frame: T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1)

    Preliminary measure of effectiveness on selective attention.

Other outcomes

  1. Cost-effectiveness

    Time frame: T0 (0 months - baseline); T3 (6 months after T1-post intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Zaccagnino, PsyD

CONTACT

[email protected]

00393288657355

Martino Belvederi Murri, MD

CONTACT

[email protected]

00393335248720

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • University Hospital of Cagliari

Registry information

Official study 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.

Acronym: INCEPT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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