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

NCT05815693 | Unknown

• 1 other identifier: ASST LECCO, DEP. ICU
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1

NO INTERVENTION

usual care for anxiety, depression, chronic pain and insomnia

Group 2

EXPERIMENTAL

mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia

Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)

Interventions

mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) BEHAVIORAL

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.

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care survivors
• Surviving COVID-19 patients
• Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy

You may not qualify if:

• Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
• Patients not hospitalized in intensive care for COVID-19

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lecco: lead

Study Sites (1)

ASST Lecco

Lecco, 23814, Italy

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Mindfulness-Based Stress Reduction; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vincenzo Damico

  Azienda Socio Sanitaria Territoriale di Lecco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo LC Damico, PhD

CONTACT

+39 3409297118; vi.damico@asst-lecco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse (RN), Doctor of Philosophy (PhD), Department of Anesthesia and Critical Care

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 18, 2023
• Study Start: April 13, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)