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

Sponsor

Azienda Socio Sanitaria Territoriale di Lecco (Other)

Overall Status

Recruiting

CT.gov ID

NCT05815693

Collaborator

(none)

140

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

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) and cognitive behavioral therapy (CBT) or usual care.

Condition or Disease	Intervention/Treatment	Phase
Post Acute COVID-19 Syndrome	Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR) and Cognitive Behavioral Therapy CBT

Actual Study Start Date :

Apr 13, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group 1 usual care for anxiety, depression, chronic pain and insomnia
Experimental: Group 2 mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) 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 and CBT CBT (n = 63), or usual care (n = 62).CBT (training to change -related thoughts and behaviors) and 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.

Arm

Intervention/Treatment

No Intervention: Group 1

usual care for anxiety, depression, chronic pain and insomnia

Experimental: Group 2

mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) 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 and CBT CBT (n = 63), or usual care (n = 62).CBT (training to change -related thoughts and behaviors) and 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.

Outcome Measures

Primary Outcome Measures

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST Lecco	Lecco		Italy	23814

Sponsors and Collaborators

Azienda Socio Sanitaria Territoriale di Lecco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vincenzo Damico, Registered Nurse (RN), Doctor of Philosophy (PhD), Department of Anesthesia and Critical Care, Azienda Socio Sanitaria Territoriale di Lecco

ClinicalTrials.gov Identifier:

NCT05815693

Other Study ID Numbers:

ASST LECCO, DEP. ICU

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 18, 2023