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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post Acute COVID-19 Syndrome

Intervention / Treatment
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* Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intensive care survivors Surviving COVID-19 patients Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy Exclusion Criteria: Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy Patients not hospitalized in intensive care for COVID-19
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>usual care for anxiety, depression, chronic pain and insomnia | |
| Experimental: Group 2<br>mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia | Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | 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 | 6 months and 1 year | 
| Anxiety | an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure | 6 months and 1 year | 
| Depression | a depressed mood or loss of pleasure or interest in activities for long periods of time | 6 months and 1 year | 
| Insomnia | 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 | 6 months and 1 year |