What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) like natalizumab, which can cause side effects such as liver injury, progressive multifocal leukoencephalopathy (PML), and other infections. Non-pharmacologic treatments, such as online psychological interventions and physiotherapy, generally have fewer side effects. Online psychological programs have shown no adverse events related to suicidal ideation, while physiotherapy may cause minor, short-lived discomfort. These treatments aim to improve mobility, mood, and overall well-being in MS patients.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Multiple Sclerosis include disease-modifying therapies such as oral dimethyl fumarate (BG-12) and injectable glatiramer acetate. These treatments have been shown to reduce relapse rates and new brain lesions in patients with MS. The conscientiousness-based phone app being studied is a novel approach aimed at improving health management and employment, but it does not directly relate to the pharmacological treatments previously approved.

What other types of research exist?

Promising alternatives to a conscientiousness-based phone app for MS patients include: 1) Web-based self-management systems that utilize electronic personal health records (e-PHRs) to improve self-assessed and clinician-assessed well-being, 2) Mindfulness-based interventions delivered via videoconferencing, which have shown feasibility and acceptability, and 3) Smartphone applications designed for recovery support and health management, which have demonstrated efficacy in other chronic conditions.

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Behavioral Intervention

Technology-Assisted Conscientiousness Therapy for Multiple Sclerosis (TACT-MS Trial)

N/A

Waitlist Available

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline only

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a phone app called 'Conscientiousness-Coach' designed to help people manage their health and work better. It targets people with Multiple Sclerosis who have low conscientiousness and includes healthy individuals over 60 for comparison. The app uses cognitive-behavioral techniques to help users become more organized and responsible.

Who is the study for?

This trial is for adults over 18 with Multiple Sclerosis (MS) who are currently working and have a low score on the NEO-FFI Conscientiousness test, indicating less conscientious behavior than average. People with substance abuse issues, psychiatric disorders, or neurological diseases other than MS cannot participate.

What is being tested?

The study is testing a phone app designed to improve health management and work life for people with MS by boosting their conscientiousness—a personality trait linked to responsible and organized behavior.

What are the potential side effects?

Since this intervention involves using an app rather than medication, traditional side effects are not expected. However, users may experience stress or frustration if they find it challenging to engage with the technology or adhere to its recommendations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline only

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline only

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline only for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Buffalo Vocational Monitoring Survey (BVMS): change from baseline to 12 weeks and from baseline to 24 weeks

Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks

The Valued Living Questionnaire (VLQ): change from baseline to 12 weeks and from baseline to 24 weeks

Secondary study objectives

Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks

Beck Depression Inventory 2nd Edition (BDI-II): change from baseline to 12 weeks and from baseline to 24 weeks

Multiple Sclerosis

+5 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: InterventionExperimental Treatment1 Intervention

Group II: Waitlist ControlActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Conscientiousness Coach

2021

N/A

~60

Do I qualify?Apply below to find out

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 immunomodulatory drugs that modulate the immune system to reduce relapse frequency and severity, and non-pharmacologic approaches like physiotherapy and mindfulness-based interventions that improve mobility, mood, and quality of life. The Conscientiousness-Based Phone App likely enhances self-management and adherence to treatment plans through behavioral interventions, which is crucial for MS patients as it can lead to better disease management, reduced symptom severity, and improved daily functioning.

Best Methods of Communicating Clinical Trial Data to Improve Understanding of Treatments for Patients with Multiple Sclerosis.