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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
10-session ACT-re-enforced CBT intervention.
Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry
Malmo, Sweden
RECRUITINGSödersjukhuset AB, Region Stockholm
Stockholm, Sweden
RECRUITINGFeasibility with respect to willingness for treatment study inclusion
Proportion of patients screened who consent to and initiate the treatment study
Time frame: 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
Time frame: 2 weeks post-treatment
Patient satisfaction with therapy intervention
Therapy and Therapist Scale-Revised (STTS-R)
Time frame: 2 weeks post-treatment
Reduction of HADS anxiety score
Reduction of HADS anxiety score
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduction of HADS depression score
Reduction of HADS depression score
Time frame: 2 weeks, 3 and 12 months post-treatment
Improved mental health-related quality of life
Improved mental health component summary score of SF-36v2
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduced fatigue
Modified Fatigue Impact Scale (MFIS)
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduced post-traumatic symptoms
Posttraumatic Stress Disorder Checklist (PCL-5) scale
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Time frame: 2 weeks, 3 and 12 months post-treatment