Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
- Conditions
- Post Acute COVID-19 Syndrome
- Interventions
- Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)
- Registration Number
- NCT05815693
- Lead Sponsor
- Azienda Socio Sanitaria Territoriale di Lecco
- 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Intensive care survivors
- Surviving COVID-19 patients
- Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy
- Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
- Patients not hospitalized in intensive care for COVID-19
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia
- Primary Outcome Measures
Name Time Method Chronic pain 6 months and 1 year pain that persists or recurs for longer than 3 months, and it exerts an enormous personal and economic burden, affecting more than 30% of people worldwide
Insomnia 6 months and 1 year a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep
Anxiety 6 months and 1 year an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
Depression 6 months and 1 year a depressed mood or loss of pleasure or interest in activities for long periods of time
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ASST Lecco
🇮🇹Lecco, Italy