Treatment of Post-covid Syndrome in Patients Treated in Intensive Care

Study Overview
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Brief Summary
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The present study is a pilot randomized controlled trial, which identifies and diagnoses mental health problems in survivors of critical COVID-19 infection at 12 months post-ICU care, and randomize patients to either an ACT-enforced CBT intervention, or to treatment as usual.

Detailed Description
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This is a pilot RCT aiming to intervene in symptoms of poor mental health in COVID survivors at 12 months after ICU care for the COVID infection. Based on the uncertain number of patents who screen positive for mental health problems 12 months after ICU care, based on the novelty of the condition assessed, and the uncertainty about which treatment effects to expect on mental health outcomes, the study was designed as a pilot study, with feasibility measures (consent, adherence and satisfaction with the treatment) as the primary variables, and with effects on mental health symptoms as secondary variables. The study plans to assess and randomize a convenience sample of patients, as it can not be estimated which numbers can be expected, but it is aimed to include at least 40 patients in the study (20 in the intervention group and 20 in the control group). Specifically, the present study aims to investigate early predictors (during ICU-care) of post-covid syndrome occurring at 3-6 months, 12 months, and 36 months, respectively, including cognitive and mental health problems, deepen the understanding of mental health symptoms in ICU-treated COVID-19 survivors, mental health-related treatment seeking, changes in addictive behaviors, and the diagnostic meaning of mental health symptoms expressed in COVID-19 survivors, and conduct a clinical treatment study with the following research question: for patients with post-covid mental health symptoms after 12 months, is an intervention of Cognitive Behavioral Therapy (CBT) with Acceptance and Commitment Therapy (ACT), when compared to standard clinical care (referral to primary care), feasible and associated with improved patient adherence and patient satisfaction, and secondly, does it improve the outcome of post-covid anxiety symptoms and secondary other symptoms of poor mental health and quality of life?

Official Title
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Detection and Treatment of Long-term Symptoms - Post-covid Syndrome - in Patients Who Have Been Treated in Intensive Care for COVID-19.

Conditions
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COVID-19, Mental Health Disorder

Intervention / Treatment
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* Behavioral: CBT/ACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 survivors who screen positive for clinical anxiety or depression, defined as reaching a score of ≥ 8 on either the anxiety or depression sub-scales within the questionnaire HADS at the standard 12-months follow-up Exclusion Criteria: Conditions in which patients are acutely suicidal, psychotic, suffering from a mental disorder requiring in-patient psychiatric treatment, opposed to receiving a psycho-therapeutic intervention, or with cognitive problems or language difficulties which are judged to be too extensive for the informed consent procedure and for a psycho-therapeutic intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT/ACT<br>Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT) | Behavioral: CBT/ACT<br>* 10-session ACT-re-enforced CBT intervention.<br>|
| Active Comparator: TAU<br>Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care). | Behavioral: CBT/ACT<br>* 10-session ACT-re-enforced CBT intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility with respect to willingness for treatment study inclusion | Proportion of patients screened who consent to and initiate the treatment study | 8 weeks post-assessment | 
| Feasibility with respect to patient adherence | Proportion of patients who remain in the treatment study including complete treatment settings and 2-week follow-up | 2 weeks post-treatment | 
| Patient satisfaction with therapy intervention | Therapy and Therapist Scale-Revised (STTS-R) | 2 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of HADS anxiety score | Reduction of HADS anxiety score | 2 weeks, 3 and 12 months post-treatment | 
| Reduction of HADS depression score | Reduction of HADS depression score | 2 weeks, 3 and 12 months post-treatment | 
| Improved mental health-related quality of life | Improved mental health component summary score of SF-36v2 | 2 weeks, 3 and 12 months post-treatment | 
| Reduced fatigue | Modified Fatigue Impact Scale (MFIS) | 2 weeks, 3 and 12 months post-treatment | 
| Reduced post-traumatic symptoms | Posttraumatic Stress Disorder Checklist (PCL-5) scale | 2 weeks, 3 and 12 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, mental health disorder, cognitive-behavioral therapy, acceptance and commitment therapy, addictive behavior, ICU