Clinical trial NCT05119608: Treatment of Post-covid Syndrome in Patients Treated in Intensive Care
Official title: Detection and Treatment of Long-term Symptoms - Post-covid Syndrome - in Patients Who Have Been Treated in Intensive Care for COVID-19.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Mental Health Disorder
Keywords: COVID-19
mental health disorder
cognitive-behavioral therapy
acceptance and commitment therapy
addictive behavior
ICU
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Lund University
name: Karolinska Institutet
First posted: 2021-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility with respect to willingness for treatment study inclusion
timeFrame: 8 weeks post-assessment
measure: Feasibility with respect to patient adherence
timeFrame: 2 weeks post-treatment
measure: Patient satisfaction with therapy intervention
timeFrame: 2 weeks post-treatment
Secondary outcomes:
measure: Reduction of HADS anxiety score
timeFrame: 2 weeks, 3 and 12 months post-treatment
measure: Reduction of HADS depression score
timeFrame: 2 weeks, 3 and 12 months post-treatment
measure: Improved mental health-related quality of life
timeFrame: 2 weeks, 3 and 12 months post-treatment
measure: Reduced fatigue
timeFrame: 2 weeks, 3 and 12 months post-treatment
measure: Reduced post-traumatic symptoms
timeFrame: 2 weeks, 3 and 12 months post-treatment
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry
city: Stockholm
country: Sweden
facility: Södersjukhuset AB, Region Stockholm
Study officials:
References: