A clinical trial funded by the National Multiple Sclerosis Society is recruiting adult patients with multiple sclerosis (MS) to test two non-pharmacological strategies to manage MS-related chronic pain.
The trial (NCT03782246) will be conducted at the University of Washington, and plans to enroll about 250 participants across the United States who have been diagnosed with MS and also have chronic pain.
Pain is a common symptom experienced by many patients with MS. It can be very debilitating and severely affect patients’ daily lives. Chronic pain also is associated with sleep disruption, depression, and poorer health.
Pharmacological products can be used to ease pain, however, they often don’t offer complete pain relief and can cause unwanted side effects.
Alternative strategies, such as exercising, hydrotherapy, or acupuncture, have been beneficial in easing pain.
In this trial researchers will evaluate the potential of cognitive behavioral therapy and mindfulness-based cognitive therapy to reduce MS-associated pain and other symptoms. They also will test if these alternative treatments can be given effectively through videoconference.
Cognitive behavioral therapy (CBT) is a type of psychotherapy designed to improve self-awareness and reduce inaccurate or negative thinking. Such an approach can allow a person to perceive challenging situations more clearly and to respond to them more easily and effectively.
Previous studies have shown that CBT can reduce pain intensity in people with MS.
Mindfulness-based cognitive therapy (MBCT) is a different non-pharmacological therapy that integrates mindfulness meditation within a CBT-oriented strategy. This combined approach is believed to help prevent unhelpful thoughts and behaviors, but also to improve attentional control and meditative behavior.
According to a National MS Society press release, the trial will enroll adult patients (18 or older) with any type of MS who have had daily pain for more than three months, with an average pain intensity greater than 3 on the 0-10 numerical rating scale.
All participants need to have access to and be able to communicate by telephone and in English. Because the treatments will be conducted by videoconference, they also have to have access to a computer or digital device with internet access.
Participants will be assigned randomly to receive CBT, MBCT, or to continue their usual care for pain and MS. The interventions will be delivered in weekly sessions of 90-minutes, with groups of six to eight participants. During the sessions, patients will see and hear one another, and also will have access to visual information such as slides.
The intervention will be performed for a total of eight weeks, and between each session participants will be asked to practice the new learned skills.
Those who receive the usual care will have the opportunity to receive the intervention later.
The effects of the different treatment strategies in pain intensity, sleep disturbances, fatigue, physical function, and depressive symptoms will be reported by telephone.
To learn more about the study and how to participate, contact the research team via email at [email protected] or by telephone at (855) 320-8230.