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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119608
• Other study ID #: 2021-05128
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 15, 2025

Study information

• Verified date: January 2023
• Source: Region Skane
• Contact: Anders Håkansson, PhD
• Phone: +46 46 175596
• Email: anders_c.hakansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. 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,

2. 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

3. 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 15, 2025
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• CBT/ACT
10-session ACT-re-enforced CBT intervention.

Locations

Country	Name	City	State
Sweden	Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry	Malmö
Sweden	Södersjukhuset AB, Region Stockholm	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Karolinska Institutet, Lund University, Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient satisfaction with therapy intervention	Therapy and Therapist Scale-Revised (STTS-R)	2 weeks post-treatment
Secondary	Reduction of HADS anxiety score	Reduction of HADS anxiety score	2 weeks, 3 and 12 months post-treatment
Secondary	Reduction of HADS depression score	Reduction of HADS depression score	2 weeks, 3 and 12 months post-treatment
Secondary	Improved mental health-related quality of life	Improved mental health component summary score of SF-36v2	2 weeks, 3 and 12 months post-treatment
Secondary	Reduced fatigue	Modified Fatigue Impact Scale (MFIS)	2 weeks, 3 and 12 months post-treatment
Secondary	Reduced post-traumatic symptoms	Posttraumatic Stress Disorder Checklist (PCL-5) scale	2 weeks, 3 and 12 months post-treatment