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

University Hospital, Akershus

Status: Completed

Conditions: COVID-19

Treatments: Behavioral: Rehabilitation based on CBT principles

Study type: Interventional

Funder types: Other

Identifiers

NCT05196451

21/12248

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

Short-time rehabilitation

Active Comparator group

Description:

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)

Treatment:

Behavioral: Rehabilitation based on CBT principles

Care as usual

No Intervention group