What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include cognitive-behavioral therapy (CBT) and disease-modifying therapies like dimethyl fumarate (BG-12). CBT is generally well-tolerated but may cause temporary emotional discomfort as patients confront challenging thoughts and behaviors. Dimethyl fumarate can cause side effects such as flushing, gastrointestinal issues (e.g., diarrhea, nausea, abdominal pain), and a decrease in white blood cell count, which may increase infection risk. Complementary treatments like cannabinoids have shown inconsistent results and may cause dizziness, dry mouth, and cognitive changes. Behavioral interventions focusing on self-efficacy, outcome expectations, goal setting, and addressing impediments are generally safe but require further study to fully understand their side effects.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis include oral dimethyl fumarate (BG-12) and subcutaneous glatiramer acetate, both of which have shown efficacy in reducing relapse rates and brain lesions. Additionally, behavioral interventions focusing on enhancing self-efficacy, outcome expectations, goal setting, and addressing impediments through social cognitive theory are being studied to improve physical activity, mobility, cognition, and quality of life in MS patients.

What other types of research exist?

Promising novel alternatives to behavioral interventions for Multiple Sclerosis patients include: 1) Aerobic exercise programs, which have shown benefits in brain function and structure, as well as non-motor symptoms. 2) Digital technology-assisted management, such as smartphone recovery applications, which support therapeutic contact and cognitive enhancement. 3) Mindfulness-based stress reduction (MBSR), which has demonstrated improvements in mindfulness, positive affect, self-compassion, and anxiety. 4) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can improve sleep-related quality of life and insomnia symptoms, potentially aiding overall well-being.

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Behavioral Intervention for Multiple Sclerosis (BIPAMS Trial)

N/A

Waitlist Available

Led By Robert W Motl, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MS

Ability to ambulate with or without assistance (i.e. walking with or without a cane or walker, but not a wheelchair)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program to help people with MS become more active. The program aims to improve their mobility, thinking skills, and overall well-being by boosting their confidence and setting clear goals. Researchers believe this will lead to lasting positive changes in their physical activity and quality of life.

Who is the study for?

This trial is for adults aged 18-64 with Multiple Sclerosis who are not currently active, can walk with or without assistance, and have been relapse-free for the last 30 days. Participants must have internet access, be willing to complete questionnaires and wear an accelerometer. Those at moderate/high risk for strenuous exercise or more than one 'yes' on the PAR-Q are excluded.

What is being tested?

The study tests a 6-month online behavioral intervention (BIPAMS) aimed at increasing physical activity against a control condition (WELLMS). It will also assess improvements in mobility, cognition, symptoms and quality of life due to increased physical activity facilitated by changes in self-efficacy and goal setting.

What are the potential side effects?

Since this is a behavioral intervention focusing on increasing physical activity through internet-based programs rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience typical exercise-related discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple sclerosis (MS).

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I can walk with or without help from a cane or walker.

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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.

Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.

Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.

Secondary study objectives

Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline.

Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.

Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.

+8 more

Other study objectives

Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the Exercise Self-Efficacy Scale at 6 and 12 months from baseline.

Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the MS Self-Efficacy Sale at 6 and 12 months from baseline.

Changes of self-report measures based on goal setting through the Exercise Goal Setting and Planning Scale at 6 and 12 months from baseline.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BIPAMSExperimental Treatment1 Intervention

The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.

Group II: WELLMSActive Control1 Intervention

The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) include pharmacologic options like dimethyl fumarate and glatiramer acetate, which modulate the immune system to reduce inflammation and prevent immune attacks on the myelin sheath. Non-pharmacologic treatments, such as behavioral interventions based on social cognitive theory, focus on enhancing self-efficacy, outcome expectations, goal setting, and addressing impediments. These interventions aim to increase physical activity, improve mobility, and manage symptoms like fatigue, depression, and pain. Understanding these mechanisms is crucial for MS patients as it underscores the importance of a comprehensive treatment plan that combines medication and behavioral strategies to improve overall quality of life.

Cognitive Behavioral Therapy for the Management of Multiple Sclerosis-Related Pain: A Randomized Clinical Trial.Efficacy of a behavioral intervention for reducing sedentary behavior in persons with multiple sclerosis: a pilot examination.