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Completed

NCT Number: NCT05196451

Short-time Intervention in Post-Covid Syndrome 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vegard Bratholm Wyller

Oslo, 1170, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation based on CBT principles

Behavioral

Cf. arm description

Primary outcomes

  1. Physical Functioning

    Time frame: 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 outcomes

  1. Fatigue

    Time frame: Immediately after intervention (time T1)

    Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.

  2. Fatigue

    Time frame: At 12 months follow-up (time T2)

    Chalder fatigue questionnaire, total sum score

  3. Depression/anxiety

    Time frame: Immediately after intervention (time T1)

    Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.

  4. Depression/anxiety

    Time frame: At 12 months follow-up (time T2)

    Hospital Anxiety and Depresssion Scale, total score

  5. Adverse effects

    Time frame: Immediately after intervention (time T1)

    Self-invented questionnaire on adverse effects

  6. Adverse effects

    Time frame: At 12 months follow-up (time T2)

    Self-invented questionnaire on adverse effects

  7. Physical Functioning

    Time frame: At 12 months follow-up (time T2)

    Physical Functioning subscale from the SF-36 inventory

  8. Recovery from PIFS

    Time frame: Immediately after intervention (time T1)

    Recovery from post-infective fatigue syndrome (PIFS)

  9. Recovery from PIFS

    Time frame: At 12 months follow-up (time T2)

    Recovery from post-infective fatigue syndrome (PIFS)

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

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

Acronym: SIPCOV

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 19, 2022
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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