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

Azienda Socio Sanitaria Territoriale di Lecco

Status: Enrolling

Conditions: Post Acute COVID-19 Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05815693

ASST LECCO, DEP. ICU

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group 1

No Intervention group

Description:

usual care for anxiety, depression, chronic pain and insomnia

Group 2

Experimental group

Description:

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

Treatment:

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