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

NCT ID: NCT05815693

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2023-11-30

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

Conditions

Post Acute COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

usual care for anxiety, depression, chronic pain and insomnia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale di Lecco

OTHER

Sponsor Role: lead

Responsible Party

Vincenzo Damico

Registered Nurse (RN), Doctor of Philosophy (PhD), Department of Anesthesia and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Damico

Role: PRINCIPAL_INVESTIGATOR

Azienda Socio Sanitaria Territoriale di Lecco

Locations

ASST Lecco

Lecco, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo LC Damico, PhD

Role: CONTACT

vi.damico@asst-lecco.it

+39 3409297118 ext. LC

Facility Contacts

VINCENZO LC DAMICO

Role: primary

vi.damico@asst-lecco.it

3409297118 ext. LC

Other Identifiers

ASST LECCO, DEP. ICU

Identifier Type: -

Identifier Source: org_study_id