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

Primary Purpose

COVID-19, Mental Health Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT/ACT
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, mental health disorder, cognitive-behavioral therapy, acceptance and commitment therapy, addictive behavior, ICU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatryRecruiting
  • Södersjukhuset AB, Region StockholmRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT/ACT

TAU

Arm Description

Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT)

Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of HADS anxiety score
Reduction of HADS anxiety score
Reduction of HADS depression score
Reduction of HADS depression score
Improved mental health-related quality of life
Improved mental health component summary score of SF-36v2
Reduced fatigue
Modified Fatigue Impact Scale (MFIS)
Reduced post-traumatic symptoms
Posttraumatic Stress Disorder Checklist (PCL-5) scale

Full Information

First Posted
November 11, 2021
Last Updated
January 12, 2023
Sponsor
Region Skane
Collaborators
Region Stockholm, Lund University, Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05119608
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
November 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Region Stockholm, Lund University, Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Mental Health Disorder
Keywords
COVID-19, mental health disorder, cognitive-behavioral therapy, acceptance and commitment therapy, addictive behavior, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT/ACT
Arm Type
Experimental
Arm Description
Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT)
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care).
Intervention Type
Behavioral
Intervention Name(s)
CBT/ACT
Intervention Description
10-session ACT-re-enforced CBT intervention.
Primary Outcome Measure Information:
Title
Feasibility with respect to willingness for treatment study inclusion
Description
Proportion of patients screened who consent to and initiate the treatment study
Time Frame
8 weeks post-assessment
Title
Feasibility with respect to patient adherence
Description
Proportion of patients who remain in the treatment study including complete treatment settings and 2-week follow-up
Time Frame
2 weeks post-treatment
Title
Patient satisfaction with therapy intervention
Description
Therapy and Therapist Scale-Revised (STTS-R)
Time Frame
2 weeks post-treatment
Secondary Outcome Measure Information:
Title
Reduction of HADS anxiety score
Description
Reduction of HADS anxiety score
Time Frame
2 weeks, 3 and 12 months post-treatment
Title
Reduction of HADS depression score
Description
Reduction of HADS depression score
Time Frame
2 weeks, 3 and 12 months post-treatment
Title
Improved mental health-related quality of life
Description
Improved mental health component summary score of SF-36v2
Time Frame
2 weeks, 3 and 12 months post-treatment
Title
Reduced fatigue
Description
Modified Fatigue Impact Scale (MFIS)
Time Frame
2 weeks, 3 and 12 months post-treatment
Title
Reduced post-traumatic symptoms
Description
Posttraumatic Stress Disorder Checklist (PCL-5) scale
Time Frame
2 weeks, 3 and 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Håkansson, PhD
Phone
+46 46 175596
Email
anders_c.hakansson@med.lu.se
Facility Information:
Facility Name
Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarina Hartman
Email
katarina.hartman@skane.se
Facility Name
Södersjukhuset AB, Region Stockholm
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cronhjort, PhD
Email
maria.cronhjort@sll.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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