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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Rehabilitation based on CBT principles

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 1170
    • Vegard Bratholm Wyller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care as usual
Active Comparator: Short-time rehabilitation; 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; Cf. arm description

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Principal Investigator: Vegard B Wyller, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 21/12248

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No