COVID-19NCT05119608
Treatment of Post-covid Syndrome in Patients Treated in Intensive Care
A study testing CBT/ACT in people with COVID-19 and Mental Health Disorder, run by Region Skane at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Mental Health Disorder
- What is being tested?
- CBT/ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Nov 2021to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry
Malmö, 205 02
Katarina Hartman, katarina.hartman@skane.se
- Recruiting
Södersjukhuset AB, Region Stockholm
Stockholm
Maria Cronhjort, PhD, maria.cronhjort@sll.se
About this study
Official title: Detection and Treatment of Long-term Symptoms - Post-covid Syndrome - in Patients Who Have Been Treated in Intensive Care for COVID-19.
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.
Read the 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?
- Conditions
- COVID-19, Mental Health Disorder
- Being tested
- CBT/ACT
- Keywords
- COVID-19, mental health disorder, cognitive-behavioral therapy, acceptance and commitment therapy, addictive behavior, ICU
- Medical subject headings
- COVID-19, Mental Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT/ACTBehavioural
10-session ACT-re-enforced CBT intervention.
| Study group | Role | What they receive |
|---|---|---|
| CBT/ACT | Experimental | Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT) Receives: Behavioral: CBT/ACT |
| TAU | Active comparator | Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care). Receives: Behavioral: CBT/ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility with respect to willingness for treatment study inclusion
Proportion of patients screened who consent to and initiate the treatment study
Measured: 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
Measured: 2 weeks post-treatment
Patient satisfaction with therapy intervention
Therapy and Therapist Scale-Revised (STTS-R)
Measured: 2 weeks post-treatment
Secondary outcomes (5)
Reduction of HADS anxiety score
Reduction of HADS anxiety score
Measured: 2 weeks, 3 and 12 months post-treatment
Reduction of HADS depression score
Reduction of HADS depression score
Measured: 2 weeks, 3 and 12 months post-treatment
Improved mental health-related quality of life
Improved mental health component summary score of SF-36v2
Measured: 2 weeks, 3 and 12 months post-treatment
Reduced fatigue
Modified Fatigue Impact Scale (MFIS)
Measured: 2 weeks, 3 and 12 months post-treatment
Reduced post-traumatic symptoms
Posttraumatic Stress Disorder Checklist (PCL-5) scale
Measured: 2 weeks, 3 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Sep 2022
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Lund University, Karolinska Institutet
- Responsible party
- Principal investigator, Anders C Håkansson, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119608
- Sponsor's protocol ID
- 2021-05128
- Status last verified
- Jan 2023
- First submitted
- 11 Nov 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Treatment of Long-term Symptoms - Post-covid Syndrome - in Patients Who Have Been Treated in Intensive Care for COVID-19.
- ClinicalTrials.gov ID
- NCT05119608
- Acronym / sponsor ID
- 2021-05128
- Conditions
- COVID-19, Mental Health Disorder
- Keywords
- COVID-19, mental health disorder, cognitive-behavioral therapy, acceptance and commitment therapy, addictive behavior, ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Region Stockholm, Lund University, Karolinska Institutet
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| CBT/ACT | Experimental | Behavioral: CBT/ACTCognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT) |
| TAU | Active comparator | Behavioral: CBT/ACTTreatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT/ACT10-session ACT-re-enforced CBT intervention. | Behavioural | CBT/ACT, TAU |
Primary outcome
Feasibility with respect to willingness for treatment study inclusion
Time frame: 8 weeks post-assessment
Proportion of patients screened who consent to and initiate the treatment study
Feasibility with respect to patient adherence
Time frame: 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
Time frame: 2 weeks post-treatment
Therapy and Therapist Scale-Revised (STTS-R)
5 secondary outcomes
Reduction of HADS anxiety score
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduction of HADS depression score
Time frame: 2 weeks, 3 and 12 months post-treatment
Improved mental health-related quality of life
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduced fatigue
Time frame: 2 weeks, 3 and 12 months post-treatment
Reduced post-traumatic symptoms
Time frame: 2 weeks, 3 and 12 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT/ACT in people with COVID-19 and Mental Health Disorder, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Håkansson, PhD (+46 46 175596, anders_c.hakansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility with respect to willingness for treatment study inclusion (time frame: 8 weeks post-assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.