NCT05815693

Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors

Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale di Lecco · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Conditions

• Post Acute COVID-19 Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)	Patients with long-term consequences of COVID-19 (Chronic pain, anxiety, depression or insomnia) enrolled and randomly assigned to receive MBSR (n = 63), or usual care (n = 62). MBSR (training in mindfulness meditation and yoga) were delivered in 12 months with 2-hour groups each 2 months. Usual care included anything care participants received such as drug therapy.

Timeline

• Start date: 2023-04-13
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2023-04-18
• Last updated: 2023-06-29

Locations

1 site across 1 country: Italy