Pauline Anderson

October 16, 2015

BARCELONA — An online program based on cognitive-behavioral therapy (CBT) that addresses sleep, relaxation, stress, and related elements promises to treat one of the most common symptoms in patients with multiple sclerosis (MS): fatigue.

A new study showed that the self-management program reduced fatigue and improved activity levels in patients with MS compared with wait-list control.

"Fatigue is not a fate that patients should have to put up with, and doctors should remember that medication is not the only treatment option for MS-related fatigue," said Jana Pöttgen, a clinical psychologist at the Institute of Neuro-immunology and Clinical MS Research, University Medical Center, Hamburg, Germany.

Dr Jana Pöttgen

She presented the results here at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2015.

Up to 80% of patients with MS report fatigue, and half of them describe it as their worst symptom, according to lead investigator Dr Pöttgen. Research shows that fatigue can affect quality of life and employment because fatigued staff have reduced working hours and a higher rate of early retirement.

Numerous biological, psychological, and social factors contribute to fatigue in MS, and these can vary from patient to patient.

"You could say that every person has their own fatigue model," said Dr Pöttgen. "In some patients, the role of emotional factors is more pronounced and in others, behavior factors may be more responsible for fatigue."

Treating fatigue is "a big challenge" in MS, said Dr Pöttgen. Studies have examined a variety of therapeutic approaches, including behavioral and pharmacologic interventions (such as 4-amimopyridine, modafinil [a wakefulness-promoting product], and high-dose aspirin).

Sustained Effects

Research on the effects of pharmacologic treatments is weak, but there is some evidence that physical exercise and energy conservation techniques might decrease fatigue, she said.

However, these interventions can be costly and involve travel to and from therapy.

"Time and/or transportation problems can affect participation in these programs, and they seem to be major limiting factors for MS patients, especially when they have a substantial fatigue syndrome," said Dr Pöttgen.

More and more evidence points to CBT as a promising strategy to reduce fatigue. In MS, CBT was used to treat fatigue in 72 patients in a randomized controlled trial that compared it with relaxation therapy (Psychosom Med. 2008;70:205-213).

Six months after treatment, both groups in that study described clinically significant decreases in fatigue levels equivalent to or less than those measured in a nonfatigued healthy group. The positive effects were sustained up to 6 months.

Additional benefits from CBT included improvements in depression, anxiety, and stress.

Meanwhile, mounting research suggests that online interventions might help manage a variety of physical and psychological symptoms, including back pain, headache, and depression.

"CBT-based self-management programs over the Internet are rapidly growing and offer an attractive approach to treat patients when face-to-face treatment is not available, or time and energy resources are lacking," said Dr Pöttgen.

The 12-week program discussed at ECTRIMS is called ELEVIDA. The name doesn't officially stand for anything but could be a metaphor for "elevate your life," said Dr Pöttgen.

The program is based on eight modules that incorporate evidence-based cognitive-behavioral techniques. During the program, patients learn about CBT, the causes of MS fatigue, how to maintain daily diaries of activity, rest and fatigue levels, and behavioral techniques that might improve their sleep.

Keen Patient Interest

Participants are taught to understand their MS symptoms using concepts such as "symptom focusing" and to change their negative thoughts into more positive and helpful ones. They also learn stress management techniques and how to build a social support network.

When enrolled in the program, participants can communicate via simulated dialogues and respond continuously to narrative text passages. For example, the multiple-choice response options enable them to affirm a particular idea or request more information.

The text modules are illustrated with drawings or photographs and are accompanied by brief audio recordings that reiterate concepts and help users learn such skills as relaxation exercises.

Each module builds on the previous one and can be repeated within the intervention period as often as needed. Depending on a patient's reading speed, each module lasts 10 to 30 minutes.

For the study, patients with MS and a Fatigue Scale for Motor and Cognition (FSMC) total score of at least 43 were randomly assigned to the intervention group (n = 139) or to the wait-list control group (n = 136) whose members were told they had the option of entering the program after the study.

Patients seemed to be keen to try the program. The response rate was more than 75% after 6 months.

"This tells us something about the acceptance of the patients for such a study concept," said Dr Pöttgen.

The primary endpoint was fatigue as measured by the Chalder Fatigue Scale. The intervention group showed significantly greater reduction in fatigue after the intervention (at 3 months) and at 6 months (change, –4.5 [P = .0007] and –4.7 [P = .0080] points on the Chalder Fatigue Scale, respectively).

The intervention group also did better on secondary endpoints. For example, they reported significantly less anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS), and significantly better subjective cognitive assessment on the Multiple Sclerosis Neuropsychological Screening Questionnaire.

As well, fatigue as measured by the FSMC showed significant reduction in MS fatigue in the intervention group at 3 and 6 months. Those completing the online program carried out significantly more daily activities as measured by the Frenchay Activities Index Index, which looks at specific and relevant improvements, at 3 and 6 months.

No Effect on Depression

However, the program had no significant effect on depression on HADS. Although the reasons for this are unclear, Dr Pöttgen speculated that it may have something to do with patients starting off with relatively low depression scores.

"It might also be that we measured more pure fatigue and no comorbid depression symptoms."

Although the researchers expected the intervention to improve coping skills, this wasn't the case in the study. This could be because the study was not focused enough in terms of measuring specific coping skills, said Dr Pöttgen.

Because no teacher, trainer, or therapist is needed for the program, it should prove to be cost-effective, she said.

The program is not yet available to the general public. Dr Pöttgen and her colleagues are seeking funding to conduct a multinational phase 3 study of the program.

Session co-chair Tjalf Ziemssen, MD, Department of Neurology, Dresden University of Technology, Germany, asked whether the program could be compared to a "sham" treatment instead of a wait-list strategy.

Dr Pöttgen said that at this point, she "has no idea how it could work" and be managed in a randomized controlled trial setting. "But, of course that would be the next step to try to underline its efficacy."

Another delegate noted that 75% of study participants had relapsing-remitting MS (RRMS), but most patients with MS who experience fatigue have progressive MS.

The disproportionately high number of patients with RRMS in the study, said Dr Pöttgen, might be because such patients tend to be in the early stages of the disease and may be more open to new treatment options.

"It might also be that the distribution of fatigue in MS is more consistent than some study results show."

The research project was supported by the German Hertie Foundation. Dr Pöttgen has disclosed no relevant financial relationships.

Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2015. Session Hot Topics 2, #135. Presented October 8, 2015.


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