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A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue

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Abstract

The majority of people affected by Multiple Sclerosis (paMS) experience severe and disabling fatigue. A recent randomised controlled trial (RCT) showed that cognitive behaviour therapy with a clinical psychologist was an effective treatment for MS fatigue. An Internet-based version of this intervention, MS Invigor8, was developed for the current study using agile design and input from paMS. MS Invigor8 includes eight tailored, interactive sessions. The aim was to test the feasibility and potential efficacy and cost-effectiveness of the programme in a pilot RCT. 40 patients were randomised to MS Invigor8 (n = 23) or standard care (n = 17). The MS Invigor8 group accessed sessions over 8–10 weeks and received up to three 30–60 min telephone support sessions. Participants completed online standardised questionnaires assessing fatigue, mood, quality of life and service use at baseline and 10 weeks follow-up. Large between group treatment effects were found for the primary outcomes of fatigue severity (d = 1.19) and impact (d = 1.02). The MS Invigor8 group also reported significantly greater improvements in anxiety, depression and quality-adjusted life years. These data suggest that Internet-based CBT may be a clinically and cost-effective treatment for MS fatigue. A larger RCT with longer term follow-up is warranted.

Highlights

► MS Invigor8 is an 8 session web-based interactive CBT program for MS fatigue. ► 40 people with MS fatigue were randomized to the MS Invigor8 program or standard care. ► MS Invigor8 group reported significantly less fatigue (d = 1.2) at 10 weeks follow-up. ► The MS Invigor8 group also reported less anxiety and depression. ► Internet-based CBT may be a cost-effective treatment for MS fatigue.

Section snippets

Design and trial procedures

The pilot RCT study was approved by the University of Southampton ethics committee. The website was designed to incorporate all trial and treatment procedures. Participant information sheets including eligibility criteria were presented online with the facility to contact the investigators for more information. paMS who wanted to participate consented online and completed an online screening questionnaire to confirm eligibility. Those who were eligible could then consent to enter the trial and

Participants

Table 2 shows characteristics of the participants. The mean age was early forties, most participants were female, and 30% were unemployed or working less because of their MS. The groups were well matched for age and time since diagnosis. However, the intervention group had a slightly lower percentage of females, a greater percentage of people with progressive disease, and greater levels of ambulatory difficulties than the control group.

Two of the 23 treatment participants failed to complete

Discussion

This study developed a novel Internet-based intervention, MS Invigor8, which has the potential to make CBT-based self-management for fatigue more widely available to paMS. Strengths of the programme included its iterative development process with input from paMS and its basis on a theoretical and evidenced-based approach for treating MS fatigue (van Kessel and Moss-Morris, 2006, van Kessel et al., 2008). The pilot data suggest that MS Invigor8 has the potential to effectively reduce both

Conclusion

Internet CBT-based self-management appears to be a promising, acceptable and cost-effective approach for treating MS fatigue and improving broader outcomes such as distress. If future research replicates these findings MS Invigor8 may be a feasible means of delivering a CBT-based intervention to a large pool of paMS who experience troubling and disabling fatigue.

Role of the funding source

This study was funded by a grant from the UK MS Society.The society played no role in the design, conduct or write up of the study.

Acknowledgements

We would like to acknowledge the substantial input into this project of our design team including the trial coordinator, Louise Bell, programmers – Prins Adeel Butt, Lisha Chen-Wilson, and Stephanie Cobb, and Lawrence Gilbert. We would also like to thank Caroline Blakemore who conducted the think aloud interviews for the development of the website and Carolyn Powell who conducted and analysed the qualitative interviews for the pilot trial.

There were no competing interests.

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