Behavioral Intervention for Multiple Sclerosis

(BIPAMS Trial)

Overseen By Robert W Motl, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Moderate/high exercise risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

280 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity through a behavioral intervention.

What data supports the effectiveness of the treatment BIPAMS, WELLMS for multiple sclerosis?

Research shows that behavioral interventions, including exercise and stress management, can improve quality of life, reduce fatigue, and alleviate depression in people with multiple sclerosis. These treatments may also positively impact the biological processes underlying these symptoms. ^{1 2 3 4 5}

How is the BIPAMS treatment for multiple sclerosis different from other treatments?

BIPAMS is unique because it focuses on behavioral interventions like exercise, stress management, and psychotherapy to improve symptoms such as fatigue and depression in multiple sclerosis. Unlike traditional drug treatments, BIPAMS aims to change behavior and potentially influence the underlying biological processes of the disease. ^{1 6 7 8 9}

Research Team

Donald Lein, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

Internet and email access

I am willing to fill out questionnaires, wear a tracking device, and be randomly assigned to a treatment group.

Exclusion Criteria

If you answer "yes" to more than one question on the PAR-Q, you may be at moderate or high risk for strenuous exercise and won't be able to participate in the study. If you answer "yes" to only one question, you may be at low risk and can participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month behavioral intervention delivered through the Internet, focusing on increasing physical activity and improving mobility, cognition, symptoms, and quality of life.

6 months

Regular virtual sessions with a behavioral coach

Follow-up

Participants are monitored for sustained physical activity behavior and improvements in mobility, cognition, symptoms, and quality of life.

6 months

Treatment Details

Interventions

• BIPAMS
• WELLMS

Trial Overview 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.

Participant Groups

Group I: BIPAMS Experimental Treatment 1 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: WELLMS Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Biological outcome measurements for behavioral interventions in multiple sclerosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Extended outpatient rehabilitation: its influence on symptom frequency, fatigue, and functional status for persons with progressive multiple sclerosis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Does the effect of a physical activity behavioral intervention vary by characteristics of people with multiple sclerosis? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness- and Acceptance-Based Interventions for Symptom Reduction in Individuals With Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Improving the quality of mental health care in multiple sclerosis. [2015]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Psychotherapy in treatment and rehabilitation of patients with multiple sclerosis]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Changing Physical Activity Behavior in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Determinants of stress coping behaviors in patients with Multiple Sclerosis (MS-DSCB): development and psychometrics of a PRECEDE model-based questionnaire. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Beyond supervised therapy: Promoting behavioral changes in people with MS. [2020]