Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05815693
Status:
UNKNOWN
Last Update Posted:
2023-06-29
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
Sponsor:
Azienda Socio Sanitaria Territoriale di Lecco
Organization:
Study Overview
Official Title:
Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LONGCOVID
Brief Summary:
The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.
Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.
Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.
Detailed Description:
Randomized controlled clinical study. All patients who survived COVID-19 and discharged from the intensive care unit of the Lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy A group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia.
The second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy
The second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: