Post Acute COVID-19 SyndromeLONGCOVIDNCT05815693
Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
A study testing mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) in people with Post Acute COVID-19 Syndrome, run by Azienda Socio Sanitaria Territoriale di Lecco at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Acute COVID-19 Syndrome
- What is being tested?
- mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intensive care survivors
- Surviving COVID-19 patients
- Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy
Who cannot join
- Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
- Patients not hospitalized in intensive care for COVID-19
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST Lecco
Lecco, 23814
VINCENZO LC DAMICO, 3409297118 ext. LC, vi.damico@asst-lecco.it
About this study
Official title: 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.
Read the 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
- Being tested
- mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months and 1 year
Anxiety
an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
Measured: 6 months and 1 year
Depression
a depressed mood or loss of pleasure or interest in activities for long periods of time
Measured: 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
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start13 Apr 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lecco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Damico, Azienda Socio Sanitaria Territoriale di Lecco
- Investigators
- Vincenzo Damico, Principal investigator, Azienda Socio Sanitaria Territoriale di Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815693
- Sponsor's protocol ID
- ASST LECCO, DEP. ICU
- Acronym
- LONGCOVID
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
- ClinicalTrials.gov ID
- NCT05815693
- Acronym / sponsor ID
- LONGCOVID / ASST LECCO, DEP. ICU
- Conditions
- Post Acute COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di LeccoUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –usual care for anxiety, depression, chronic pain and insomnia |
| Group 2 | Experimental | Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Intensive care survivors
- Surviving COVID-19 patients
- Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy
Key exclusion criteria (2 listed)
- Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy
- Patients not hospitalized in intensive care for COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 2 |
Primary outcome
Chronic pain
Time frame: 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
Time frame: 6 months and 1 year
an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure
Depression
Time frame: 6 months and 1 year
a depressed mood or loss of pleasure or interest in activities for long periods of time
Insomnia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Damico principal investigator
Azienda Socio Sanitaria Territoriale di Lecco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) in people with Post Acute COVID-19 Syndrome, run by Azienda Socio Sanitaria Territoriale di Lecco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo LC Damico, PhD (+39 3409297118 ext. LC, vi.damico@asst-lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain (time frame: 6 months and 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.