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

Primary Purpose

Post Acute COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)
Sponsored by
Azienda Socio Sanitaria Territoriale di Lecco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Acute COVID-19 Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ASST LeccoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Arm Description

usual care for anxiety, depression, chronic pain and insomnia

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

Outcomes

Primary Outcome Measures

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
Anxiety
an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
Depression
a depressed mood or loss of pleasure or interest in activities for long periods of time
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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
June 28, 2023
Sponsor
Azienda Socio Sanitaria Territoriale di Lecco
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1. Study Identification

Unique Protocol Identification Number
NCT05815693
Brief Title
Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
Acronym
LONGCOVID
Official Title
Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale di Lecco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Acute COVID-19 Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
usual care for anxiety, depression, chronic pain and insomnia
Arm Title
Group 2
Arm Type
Experimental
Arm Description
mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chronic pain
Description
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
Time Frame
6 months and 1 year
Title
Anxiety
Description
an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
Time Frame
6 months and 1 year
Title
Depression
Description
a depressed mood or loss of pleasure or interest in activities for long periods of time
Time Frame
6 months and 1 year
Title
Insomnia
Description
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
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo LC Damico, PhD
Phone
+39 3409297118
Ext
LC
Email
vi.damico@asst-lecco.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Damico
Organizational Affiliation
Azienda Socio Sanitaria Territoriale di Lecco
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASST Lecco
City
Lecco
ZIP/Postal Code
23814
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VINCENZO LC DAMICO
Phone
3409297118
Ext
LC
Email
vi.damico@asst-lecco.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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