Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589544
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCEPT
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None