Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 21, 2022
Open Peer Review Period: Jan 21, 2022 - Mar 18, 2022
Date Accepted: Feb 24, 2022
Date Submitted to PubMed: Apr 25, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Long COVID Optimal Health Programme (LC-OHP) to enhance psychological and physical health: a feasibility randomised controlled trial protocol
ABSTRACT
Background:
Long COVID is a collection of symptoms that develop during or following a confirmed or suspected case of COVID-19, that continue for more than 12 weeks. Despite the negative impact of long COVID on people’s lives and functioning, there is no validated treatment or even rehabilitation guidance. What has been recommended thus far, is adoption of holistic management approaches. The Optimal Health Programme (OHP) is a brief 5-session, plus booster, psychosocial programme designed to support mental and physical wellbeing that has been used effectively for a range of chronic conditions.
Objective:
This study examines the feasibility and acceptability of employing a specially customised version of OHP (long COVID OHP or LC-OHP) to improve psychological and physical health of people with long COVID.
Methods:
This is a feasibility randomised controlled trial. Eligible participants aged 18 years or older who are experiencing symptoms of long COVID will be identified through their secondary practitioners with recruitment to be undertaken by the research team. Sixty participants will be randomised into a control (usual care) or an intervention (LC-OHP) group. Outcomes will be feasibility and acceptability of the programme (primary); and efficacy of the LC-OHP in improving anxiety, depression, fatigue, self-efficacy and quality of life (secondary). Up to 20 participants will be interviewed at the end of the trial to explore their experience with the programme. Quantitative data will be analysed using SPSS and differences between groups will be compared using inferential tests where appropriate. Qualitative data will be transcribed and thematically analysed to identify common emerging themes.
Results:
This is an ongoing study which began in November 2021. The study received approval from the University of Suffolk Ethics committee (RETH21/004) and from the NHS Health Research Authority (IRAS no. 304234).
Conclusions:
Long COVID has a significant impact on an individual’s mental and physical functioning. The LC-OHP offers a holistic approach that can aid people through recovery and improve self-efficacy. This would ultimately contribute to reducing the unprecedented and unsustainable demand on healthcare services including mental health seen during the pandemic. Clinical Trial: Trial registration number ISRCTN38746119.
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.