Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors (LONGCOVID)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Acute COVID-19 Syndrome
• Intervention / Treatment: Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)

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

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincenzo LC Damico, PhD; Phone Number: LC +39 3409297118; Email: vi.damico@asst-lecco.it

Study Locations

• Italy
  • Lecco, Italy, 23814
    • Recruiting
    • ASST Lecco
    • Contact: VINCENZO LC DAMICO; Phone Number: LC 3409297118; Email: vi.damico@asst-lecco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; usual care for anxiety, depression, chronic pain and insomnia
Experimental: Group 2; mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale di Lecco
• Investigators: Principal Investigator: Vincenzo Damico, Azienda Socio Sanitaria Territoriale di Lecco

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: ASST LECCO, DEP. ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No