This study aims to estimate the prevalence of long-lasting severe fatigue and identify possible risk factors in a 2-year follow-up of patients with predominantly mild-to-moderate SARS-CoV-2 infection.

Prospective cohort study.

A community-based cohort from Telemark and Agder Counties, Norway.

A total of 159 PCR-confirmed SARS-CoV-2 positive individuals in the period between 28 February and 17 December 2020 were included at 12 months after SARS-CoV-2 infection, and 93 responded at 24 months follow-up.

Fatigue was assessed using the Fatigue Severity Scale (FSS), and health-related quality of life using the RAND version of health-related quality of life Short Form 36 (SF-36), developed by the RAND Corporation. SARS-CoV-2 antibodies were measured at 12 and 24 months.

Severe fatigue (FSS ≥5) was reported by 36% at 12 months and 31% at 24 months. A higher proportion of women than men reported severe fatigue at 12 months (p=0.08). The number of acute-phase symptoms was associated with severe fatigue. No association was found between severe fatigue and anti-SARS-CoV-2 antibody levels, demographic variables or reinfection status. The severe fatigue group scored significantly lower on all domains of SF-36.

In this cohort, severe fatigue was common, greatly impacted quality of life and persisted for up to 2 years following SARS-CoV-2 infection. Fatigue severity was associated with symptom burden in the acute phase but not with antibody levels or other demographic variables. These findings underscore the need for long-term follow-up and support for affected individuals.

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

ISRCTN35167485.