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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Behavioral: Rehabilitation based on CBT principles

• Registration Number: NCT05196451
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-19
• Study Start: 2022-02-21
• Primary Completion: 2023-12-01
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-time rehabilitation	Rehabilitation based on CBT principles	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)

Primary Outcome Measures

Name	Time	Method
Physical Functioning	Immediately after intervention (time T1)	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)

Secondary Outcome Measures

Name	Time	Method
Fatigue	At 12 months follow-up (time T2)	Chalder fatigue questionnaire, total sum score
Depression/anxiety	At 12 months follow-up (time T2)	Hospital Anxiety and Depresssion Scale, total score
Physical Functioning	At 12 months follow-up (time T2)	Physical Functioning subscale from the SF-36 inventory
Adverse effects	At 12 months follow-up (time T2)	Self-invented questionnaire on adverse effects
Recovery from PIFS	At 12 months follow-up (time T2)	Recovery from post-infective fatigue syndrome (PIFS)

Trial Locations

Locations (1)

Vegard Bratholm Wyller; 🇳🇴 Oslo, Norway