What side effects are associated with this type of intervention?

Combined mental and physical health interventions for physical disabilities, such as those studied in the Positive Minds-Strong Bodies Enhanced (PMSB-E) trial, can have side effects including muscle soreness, fatigue, and potential injury from physical exercise, as well as emotional discomfort from mental health therapies. These side effects are typically mild and temporary, with the overall benefits of the interventions often outweighing the risks.

What prior FDA approvals exist?

The FDA has approved various treatments for physical disabilities, often focusing on specific conditions such as multiple sclerosis, stroke, and cerebral palsy. These treatments include medications like muscle relaxants, neuroprotective agents, and cannabinoids for symptom management. Additionally, non-pharmacologic interventions such as physical therapy, electrical stimulation, and multimodal exercise programs have been recognized for their efficacy. While specific combined mental and physical health interventions like PMSB-E are less commonly highlighted in FDA approvals, the integration of mental health support with physical rehabilitation is increasingly acknowledged as beneficial in comprehensive disability management.

What other types of research exist?

<ol> <li>Wii Balance Board-based system (eBaViR): This system uses motivational and adaptive exercises to improve standing balance in patients with acquired brain injury, showing potential for enhancing physical rehabilitation.</li> <li></li> </ol> Electrical Stimulation Therapies: These therapies, combined with home exercise programs, have shown improvements in lower extremity strength, physical functional performance, and pain reduction in patients with patellofemoral pain syndrome. 3. Progressive Resistance Exercise with Neuromuscular Electrical Stimulation: This home-based program for people with multiple sclerosis has shown feasibility and preliminary positive outcomes in strength, balance, and mobility.

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Mental and Physical Health Intervention for Preventing Disability in Minority Elders (PMSB-E Trial)

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

With mild, moderate or severe depressive or anxiety symptoms.

Be older than 18 years old

Must not have

Physically instability, acute or exacerbation of a chronic disease, or a neuro-musculoskeletal impairment

Evidence that patient lacks capacity to consent or is cognitively impaired

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3, 6, and 12 months after baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called Positive Minds-Strong Bodies Enhanced (PMSB-E) for older adults from minority groups. The program combines mental health support and physical exercise to help improve their overall well-being. It includes sessions to change negative thoughts and group exercises to build strength, all conducted in community settings. Positive-Minds-Strong Bodies (PM-SB) aims to reduce mental and physical disability for minority and immigrant elders through mental health support and physical exercise.

Who is the study for?

This trial is for Latino, Asian, Black, or non-Latino White adults over 60 with mild to severe anxiety or depression and some mobility issues but not home-bound. They must be able to attend two sessions weekly and can't have cognitive impairments, current high suicide risk, severe substance abuse, psychosis/schizophrenia history, recent specialty mental health care or physical instability.

What is being tested?

The study tests the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), designed for low-resource community settings to improve mental and physical health in minority elders. It compares PMSB-E against enhanced usual care to see which is more effective at preventing disability.

What are the potential side effects?

Since this trial involves a non-drug intervention focusing on mental and physical exercises rather than medications, typical drug side effects are not expected. However, participants may experience discomfort from new activities or emotional distress during therapy.

Eligibility Criteria

Inclusion Criteria

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

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I experience symptoms of depression or anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently stable and do not have any worsening chronic diseases or physical impairments.

Select...

I am unable to make medical decisions due to cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3, 6, and 12 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3, 6, and 12 months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, and 12 months after baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability

Hopkins Symptom Checklist-25 (change)

Late-Life Function and Disability Instrument (LLFDI) - functional component (change)

+1 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: Positive Minds Strong Bodies EnhancedExperimental Treatment1 Intervention

The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component.

Group II: Enhanced Usual CareActive Control1 Intervention

The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive Minds Strong Bodies Enhanced

2021

N/A

~430

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

Combined mental and physical health interventions, such as those studied in the Positive Minds-Strong Bodies Enhanced (PMSB-E) trial, work by simultaneously addressing the physical and psychological aspects of physical disabilities. Physical exercise improves strength, mobility, and overall physical function, while mental health support helps to overcome psychological barriers like depression and anxiety, enhancing motivation and adherence to rehabilitation programs. This dual approach is essential because it creates a more comprehensive treatment plan that can lead to better overall outcomes for patients with physical disabilities.

Preliminary Study on the Effect of an Early Physical Therapy Intervention after Sentinel Lymph Node Biopsy: A Multicenter Non-Randomized Controlled Trial.Effectiveness of allied health therapy in the symptomatic management of progressive supranuclear palsy: a systematic review.Use of electrical stimulation and exercise to increase muscle strength in a patient after surgery for cervical spondylotic myelopathy.