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

Sponsor

Region Skane (Other)

Overall Status

Recruiting

CT.gov ID

NCT05119608

Collaborator

Region Stockholm (Other), Lund University (Other), Karolinska Institutet (Other)

Enrollment

Locations

Arms

48.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Mental Health Disorder	Behavioral: CBT/ACT	N/A

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

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,
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
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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomized controlled trial1:1 randomized controlled trial

Masking:

None (Open Label)

Masking Description:

Study of a psycho-therapeutic intervention vs treatment as usual, therefore no masking of the treatment given.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Nov 15, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility with respect to willingness for treatment study inclusion [8 weeks post-assessment]
Proportion of patients screened who consent to and initiate the treatment study
Feasibility with respect to patient adherence [2 weeks post-treatment]
Proportion of patients who remain in the treatment study including complete treatment settings and 2-week follow-up
Patient satisfaction with therapy intervention [2 weeks post-treatment]
Therapy and Therapist Scale-Revised (STTS-R)

Secondary Outcome Measures

Reduction of HADS anxiety score [2 weeks, 3 and 12 months post-treatment]
Reduction of HADS anxiety score
Reduction of HADS depression score [2 weeks, 3 and 12 months post-treatment]
Reduction of HADS depression score
Improved mental health-related quality of life [2 weeks, 3 and 12 months post-treatment]
Improved mental health component summary score of SF-36v2
Reduced fatigue [2 weeks, 3 and 12 months post-treatment]
Modified Fatigue Impact Scale (MFIS)
Reduced post-traumatic symptoms [2 weeks, 3 and 12 months post-treatment]
Posttraumatic Stress Disorder Checklist (PCL-5) scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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