COVID-19SIPCOVNCT05196451
Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
A study testing Rehabilitation based on CBT principles in people with COVID-19, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Rehabilitation based on CBT principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteNorway
- Study dates
- 21 Feb 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Rehabilitation based on CBT principles
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation based on CBT principlesBehavioural
Cf. arm description
| Study group | Role | What they receive |
|---|---|---|
| Short-time rehabilitation | Active comparator | 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) Receives: Behavioral: Rehabilitation based on CBT principles |
| Care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after intervention (time T1)
Secondary outcomes (9)
Fatigue
Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.
Measured: Immediately after intervention (time T1)
Fatigue
Chalder fatigue questionnaire, total sum score
Measured: At 12 months follow-up (time T2)
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.
Measured: Immediately after intervention (time T1)
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score
Measured: At 12 months follow-up (time T2)
Adverse effects
Self-invented questionnaire on adverse effects
Measured: Immediately after intervention (time T1)
Adverse effects
Self-invented questionnaire on adverse effects
Measured: At 12 months follow-up (time T2)
Physical Functioning
Physical Functioning subscale from the SF-36 inventory
Measured: At 12 months follow-up (time T2)
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)
Measured: Immediately after intervention (time T1)
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)
Measured: At 12 months follow-up (time T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start21 Feb 2022
- Primary completion1 Dec 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Wyller, University Hospital, Akershus
- Investigators
- Vegard B Wyller, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196451
- Sponsor's protocol ID
- 21/12248
- Acronym
- SIPCOV
- Status last verified
- May 2024
- First submitted
- 14 Jan 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nerli TF, Selvakumar J, Heier I, Johnsen TL, Wyller VBB, Wisloff T. Cost-effectiveness of a brief cognitive-behavioral outpatient rehabilitation program for patients with post-COVID-19 condition within a pragmatic randomized controlled trial. Cost Eff Resour Alloc. 2026 Apr 24;24(1):73. doi: 10.1186/s12962-026-00748-7.
PubMed 42032661Nerli TF, Selvakumar J, Cvejic E, Heier I, Pedersen M, Johnsen TL, Wyller VBB. Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450744. doi: 10.1001/jamanetworkopen.2024.50744.
PubMed 39699896
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05196451
- Acronym / sponsor ID
- SIPCOV / 21/12248
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-time rehabilitation | Active comparator | Behavioral: Rehabilitation based on CBT principlesThe 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) |
| Care as usual | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation based on CBT principlesCf. arm description | Behavioural | Short-time rehabilitation |
Primary outcome
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)
9 secondary outcomes
Fatigue
Time frame: Immediately after intervention (time T1)
Fatigue
Time frame: At 12 months follow-up (time T2)
Depression/anxiety
Time frame: Immediately after intervention (time T1)
Depression/anxiety
Time frame: At 12 months follow-up (time T2)
Adverse effects
Time frame: Immediately after intervention (time T1)
Adverse effects
Time frame: At 12 months follow-up (time T2)
Physical Functioning
Time frame: At 12 months follow-up (time T2)
Recovery from PIFS
Time frame: Immediately after intervention (time T1)
Recovery from PIFS
Time frame: At 12 months follow-up (time T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 42032661Nerli TF, Selvakumar J, Heier I, Johnsen TL, Wyller VBB, Wisloff T. Cost-effectiveness of a brief cognitive-behavioral outpatient rehabilitation program for patients with post-COVID-19 condition within a pragmatic randomized controlled trial. Cost Eff Resour Alloc. 2026 Apr 24;24(1):73. doi: 10.1186/s12962-026-00748-7.
- Derived from this study: PubMed 39699896Nerli TF, Selvakumar J, Cvejic E, Heier I, Pedersen M, Johnsen TL, Wyller VBB. Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450744. doi: 10.1001/jamanetworkopen.2024.50744.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard B Wyller principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation based on CBT principles in people with COVID-19, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning (time frame: Immediately after intervention (time T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196451, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.