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

January 12, 2023 updated by: Anders C Håkansson, Region Skane

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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?

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 205 02
        • Recruiting
        • Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry
        • Contact:
      • Stockholm, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility with respect to willingness for treatment study inclusion
Time Frame: 8 weeks post-assessment
Proportion of patients screened who consent to and initiate the treatment study
8 weeks post-assessment
Feasibility with respect to patient adherence
Time Frame: 2 weeks post-treatment
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
Time Frame: 2 weeks post-treatment
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
Time Frame: 2 weeks, 3 and 12 months post-treatment
Reduction of HADS anxiety score
2 weeks, 3 and 12 months post-treatment
Reduction of HADS depression score
Time Frame: 2 weeks, 3 and 12 months post-treatment
Reduction of HADS depression score
2 weeks, 3 and 12 months post-treatment
Improved mental health-related quality of life
Time Frame: 2 weeks, 3 and 12 months post-treatment
Improved mental health component summary score of SF-36v2
2 weeks, 3 and 12 months post-treatment
Reduced fatigue
Time Frame: 2 weeks, 3 and 12 months post-treatment
Modified Fatigue Impact Scale (MFIS)
2 weeks, 3 and 12 months post-treatment
Reduced post-traumatic symptoms
Time Frame: 2 weeks, 3 and 12 months post-treatment
Posttraumatic Stress Disorder Checklist (PCL-5) scale
2 weeks, 3 and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Karolinska Institutet
Lund University
Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Anticipated)

November 15, 2025

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 11, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-05128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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