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

U

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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