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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Lund University | OTHER |
| Karolinska Institutet | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT/ACT | Experimental | Cognitive-behavioral therapy intervention with principal components of acceptance and commitment therapy (ACT) |
|
| TAU | Active Comparator | Treatment as usual, defined by standard care, i.e. referral to relevant health care provider (typically primary care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT/ACT | Behavioral | 10-session ACT-re-enforced CBT intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility with respect to willingness for treatment study inclusion | Proportion of patients screened who consent to and initiate the treatment study | 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 | 2 weeks post-treatment |
| Patient satisfaction with therapy intervention | Therapy and Therapist Scale-Revised (STTS-R) | 2 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of HADS anxiety score | Reduction of HADS anxiety score | 2 weeks, 3 and 12 months post-treatment |
| Reduction of HADS depression score | Reduction of HADS depression score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Håkansson, PhD | Contact | +46 46 175596 | anders_c.hakansson@med.lu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatry Skåne, Malmö-Trelleborg deparment of psychiatry | Recruiting | Malmö | 205 02 | Sweden |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D001523 | Mental Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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1:1 randomized controlled trial
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Study of a psycho-therapeutic intervention vs treatment as usual, therefore no masking of the treatment given.
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| 2 weeks, 3 and 12 months post-treatment |
| Improved mental health-related quality of life | Improved mental health component summary score of SF-36v2 | 2 weeks, 3 and 12 months post-treatment |
| Reduced fatigue | Modified Fatigue Impact Scale (MFIS) | 2 weeks, 3 and 12 months post-treatment |
| Reduced post-traumatic symptoms | Posttraumatic Stress Disorder Checklist (PCL-5) scale | 2 weeks, 3 and 12 months post-treatment |
| Södersjukhuset AB, Region Stockholm | Recruiting | Stockholm | Sweden |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |