Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial

Study Overview
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Brief Summary
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The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.

Official Title
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Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Rehabilitation based on CBT principles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.) Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder Informed consent to participation Exclusion criteria Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability Sustained organ damage (lung, heart, brain) following acute, serious Covid-19 Bedridden Insufficient command of Norwegian language

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short-time rehabilitation<br>The intervention consists of an individualized numbers of outpatient encounters (min. 2, max. 8) with medical doctors and physiotherapists at Kysthospitalet, Stavern, Norway. The encounters aim to foster a rehabilitation process based upon principles from Cognitive Behavioral Therapy (CBT) | Behavioral: Rehabilitation based on CBT principles<br>* Cf. arm description<br>|
| No Intervention: Care as usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Functioning | Physical Functioning subscale from the SF-36 inventory. The SF-36 comprises a total of 36 items on subjective mental, social and physical health, which are assigned to 8 dimensions. Scale ranging from 0 (poor quality of life) to 100 (best) | Immediately after intervention (time T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue. | Immediately after intervention (time T1) | 
| Fatigue | Chalder fatigue questionnaire, total sum score | At 12 months follow-up (time T2) | 
| Depression/anxiety | Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms. | Immediately after intervention (time T1) | 
| Depression/anxiety | Hospital Anxiety and Depresssion Scale, total score | At 12 months follow-up (time T2) | 
| Adverse effects | Self-invented questionnaire on adverse effects | Immediately after intervention (time T1) | 
| Adverse effects | Self-invented questionnaire on adverse effects | At 12 months follow-up (time T2) | 
| Physical Functioning | Physical Functioning subscale from the SF-36 inventory | At 12 months follow-up (time T2) | 
| Recovery from PIFS | Recovery from post-infective fatigue syndrome (PIFS) | Immediately after intervention (time T1) | 
| Recovery from PIFS | Recovery from post-infective fatigue syndrome (PIFS) | At 12 months follow-up (time T2) |