Long-term effectiveness of a [CBT] in the management of fatigue in patients with relapsing remitting multiple sclerosis, 2023, Gay et al.

Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care

Abstract
Background Fatigue is a disabling symptom of multiple sclerosis (MS). The lack of effective therapeutics has promoted the development of cognitive behavioural therapy (CBT)-based fatigue management programmes. However, their efficacy does not sustain over time. We proposed to test the long-term effectiveness of a 6-week fatigue programme supplemented with four booster sessions (‘FACETS+’) in patients with relapsing remitting MS (RRMS) and fatigue.

Methods This multicentre, randomised, controlled, open-label, parallel-group trial versus standard care enrolled patients with RRMS and fatigue. Participants were randomised to either FACETS+ plus standard care or standard care alone. The primary outcome measure was fatigue impact (Modified Fatigue Impact Scale (MFIS) at 12 months) based on intention-to-treat analyses.

Results From May 2017 to September 2020, 162 patients were screened; 105 were randomly assigned to FACETS+ (n=57) or standard care (n=48) and 88 completed the primary outcome assessment for the MFIS. At month 12, participants showed improved MFIS compared with baseline in the intervention group (mean difference (MD)=14.0 points; (95% CI 6.45 to 21.5)) and the control group (MD=6.1 points; (95% CI −0.30 to 12.5)) with a significant between-group difference in favour of the intervention group (adjusted MD=7.89 points; (95% CI 1.26 to 14.52), standardised effect size=0.52, p=0.021). No trial-related serious adverse events were reported.

Conclusions A 6-week CBT-based programme with four booster sessions is superior to standard care alone to treat MS-related fatigue in the long term (12 months follow-up). The results support the use of the FACETS+ programme for the treatment of MS-related fatigue.

https://jnnp.bmj.com/content/early/2023/08/30/jnnp-2023-331537

paywalled

 

The study protocol, including a description of the intervention, is available on ClinicalTrials.gov. According to it, the last booster session was at 9 months (week 36) whereas data collection was at 12 months.

The estimate of the mean between-group difference on the fatigue impact scale is very imprecise: 7.89 points (95% CI 1.26 to 14.52) with p = 0.021. Given that this scale is rated over 85 points (0 to 84), the confidence interval includes values below the minimal clinically important difference, so whether the intervention had a meaningful effect is debatable.

The abstract fails to mention the results for secondary outcomes, including objective ones:

- anxiety and depression (HADS)
- fatigue severity (FSS)
- sleep quality (Pittsburgh scale)
- sleepiness (Epworth scale)
- cognitive tests (PASAT & CSCT)
- impact of MS on quality of life (MSIS-29)
- quality of life (EQ5D-3L)
- healthcare utilization (numbers of visits to physicians, treatments, hospitalizations)
- professional impact (number of sick leaves)

so it is likely that there were no significant between-group changes on these outcomes.