An interventional study of Rehabilitation based on CBT principles in COVID-19, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Supportive care
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 314 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.
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Exclusion criteria
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
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)
Time frame: Immediately after intervention (time T1)
Fatigue
Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.
Time frame: Immediately after intervention (time T1)
Fatigue
Chalder fatigue questionnaire, total sum score
Time frame: At 12 months follow-up (time T2)
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.
Time frame: Immediately after intervention (time T1)
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score
Time frame: At 12 months follow-up (time T2)
Adverse effects
Self-invented questionnaire on adverse effects
Time frame: Immediately after intervention (time T1)
Adverse effects
Self-invented questionnaire on adverse effects
Time frame: At 12 months follow-up (time T2)
Physical Functioning
Physical Functioning subscale from the SF-36 inventory
Time frame: At 12 months follow-up (time T2)
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)
Time frame: Immediately after intervention (time T1)
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)
Time frame: At 12 months follow-up (time T2)
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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