Cognitive-behavioral therapy for COVID-19 survivors with mental health issues
Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)
This study is testing if combining mindfulness and therapy with regular medication can help COVID-19 survivors who are struggling with mental health issues feel better over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale di Lecco Academic / other |
| Locations | 1 site (Lecco) |
| Trial ID | NCT05815693 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) for COVID-19 survivors who have been discharged from the intensive care unit and are experiencing psychological consequences such as chronic pain, anxiety, depression, and insomnia. Participants will be randomly assigned to either receive standard pharmacological therapy or the experimental group that includes psychotherapy alongside their medication. The study will assess the long-term effects of these interventions over a 12-month period using various rating scales to measure improvements in mental health and quality of life.
Who should consider this trial
Good fit: Ideal candidates are COVID-19 survivors who were hospitalized in intensive care and are currently experiencing chronic pain, anxiety, depression, or insomnia while on pharmacological therapy.
Not a fit: Patients who are not on pharmacological therapy for their mental health issues or were not hospitalized in intensive care for COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and overall well-being of COVID-19 survivors.
How similar studies have performed: While there is emerging evidence supporting the use of psychological therapies for post-COVID conditions, this specific approach combining MBSR and CBT in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lecco
- ASST Lecco — Lecco, Italy (Recruiting)
Study contacts
- Principal investigator: Vincenzo Damico — Azienda Socio Sanitaria Territoriale di Lecco
- Study coordinator: Vincenzo LC Damico, PhD
- Email: vi.damico@asst-lecco.it
- Phone: +39 3409297118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.