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

Last updated: January 12, 2023
Sponsor: Region Skane
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Kleptomania

Treatment

N/A

Clinical Study ID

NCT05119608
2021-05128
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • COVID-19 survivors who screen positive for clinical anxiety or depression, defined asreaching a score of ≥ 8 on either the anxiety or depression sub-scales within thequestionnaire HADS at the standard 12-months follow-up

Exclusion

Exclusion Criteria:

  • Conditions in which patients are acutely suicidal, psychotic, suffering from a mentaldisorder requiring in-patient psychiatric treatment, opposed to receiving apsycho-therapeutic intervention, or with cognitive problems or language difficultieswhich are judged to be too extensive for the informed consent procedure and for apsycho-therapeutic intervention

Study Design

Total Participants: 40
Study Start date:
November 01, 2021
Estimated Completion Date:
November 15, 2025

Study 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?

Connect with a study center

  • Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry

    Malmö, 205 02
    Sweden

    Active - Recruiting

  • Södersjukhuset AB, Region Stockholm

    Stockholm,
    Sweden

    Active - Recruiting

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