What is the mechanism of action of this treatment?

Virtual symptom management programs for chronic pain, such as those studied in Active Brains 1 and Active Brains 2, often include cognitive-behavioral therapy (CBT), physical exercise, and mindfulness-based stress reduction (MBSR). CBT helps reframe negative thoughts and develop coping strategies, reducing pain perception and improving emotional well-being. Physical exercise enhances muscle strength and flexibility, reducing pain and improving physical function. Mindfulness practices manage stress and emotional responses to pain, lowering overall pain perception. These mechanisms are vital as they provide a comprehensive approach to managing chronic pain, addressing physical, psychological, and emotional aspects.

What side effects are associated with this type of intervention?

The most common treatments for chronic pain similar to those studied in the Active Brains 1 and Active Brains 2 trials include cognitive-behavioral therapy (CBT), exercise therapy, and mind-body interventions like mindfulness-based stress reduction (MBSR). Known side effects of CBT are generally minimal but can include temporary increases in distress or anxiety as patients confront difficult emotions. Exercise therapy may lead to muscle soreness, fatigue, or injury if not properly supervised. Mind-body interventions like MBSR are typically well-tolerated but can occasionally cause increased anxiety or emotional discomfort as individuals become more aware of their thoughts and feelings.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of chronic pain, including antidepressants like duloxetine and venlafaxine, which are used for conditions such as fibromyalgia and neuropathic pain. Additionally, pregabalin and gabapentin have been approved for similar indications. While these pharmacologic treatments are well-documented, the Active Brains 1 and Active Brains 2 programs focus on non-pharmacologic, virtual symptom management to improve physical, cognitive, and emotional functions. These programs align with emerging trends in chronic pain management that emphasize multidisciplinary approaches, including cognitive-behavioral therapy and other integrative therapies, though specific FDA approvals for such virtual programs are not detailed in the provided context.

What other types of research exist?

Promising alternatives to Active Brains 1 and Active Brains 2 for chronic pain patients include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and insomnia symptoms; 2) Music therapy, which can be delivered via smartphone-based mHealth interventions and has potential for pain modulation; 3) Guided imagery and progressive muscle relaxation, which have been effective in reducing pain and improving mobility in chronic pain patients; 4) Mindfulness-based stress reduction (MBSR), which has demonstrated benefits for low back pain and overall pain management.

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Active Brains Programs for Cognitive Impairment and Chronic Pain in Aging Adults

N/A

Recruiting

Led By Ana-Maria Vranceanu, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Male and female outpatients, age 60 years or older

Have nonmalignant chronic pain for more than 3 months

Must not have

Diagnosed with dementia or neurodegenerative disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 8 weeks, 6 months

Awards & highlights

Summary

This trial compares two online programs designed to help older adults with early cognitive decline and chronic pain. The programs involve group sessions that teach coping skills and strategies to manage symptoms. The goal is to improve physical, cognitive, and emotional well-being.

Who is the study for?

This trial is for adults aged 60 or older with mild cognitive issues and chronic pain, who can use a smartphone app and fitness watch. They should be able to walk briskly for six minutes, not have dementia or worsening medical conditions, and either be off certain medications for two weeks or on a stable dose.

What is being tested?

The study compares two virtual programs called Active Brains 1 & 2 designed to manage symptoms in aging individuals with early cognitive decline and chronic pain. It will evaluate improvements in physical, cognitive, and emotional functions over six months.

What are the potential side effects?

Since the interventions are non-pharmacological programs focusing on symptom management through virtual means like Zoom sessions, significant side effects are not anticipated as commonly seen with medication trials.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I have had chronic pain not caused by cancer for over 3 months.

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I can walk quickly for 6 minutes without stopping.

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I am mostly independent in my daily activities.

Exclusion Criteria

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

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I have been diagnosed with dementia or a similar brain condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks, 8 weeks, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 weeks, 8 weeks, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 8 weeks, 6 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 in PROMIS Physical Function

Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer

Change in six-minute walk test (6MWT)

Secondary study objectives

Everyday Cognition Scale (eCog-12)

Numerical Rating Scale

PROMIS Anxiety

+2 more

Other study objectives

Change in PROMIS Pain Interference - Short Form 6b V1.0

Global Cognitive and Social Engagement

Gratitude Questionnaire

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Brains 1Experimental Treatment1 Intervention

Active Brains 1 uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The Active Brains sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Group II: Active Brains 2Placebo Group1 Intervention

This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight" and "Medical appointments". The Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Brains 1

2019

N/A

~30

0 / 5Eligibility 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

Virtual symptom management programs for chronic pain, such as those studied in Active Brains 1 and Active Brains 2, often include cognitive-behavioral therapy (CBT), physical exercise, and mindfulness-based stress reduction (MBSR). CBT helps reframe negative thoughts and develop coping strategies, reducing pain perception and improving emotional well-being. Physical exercise enhances muscle strength and flexibility, reducing pain and improving physical function. Mindfulness practices manage stress and emotional responses to pain, lowering overall pain perception. These mechanisms are vital as they provide a comprehensive approach to managing chronic pain, addressing physical, psychological, and emotional aspects.

Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It?A Systematic Review of Technology-assisted Self-Management Interventions for Chronic Pain: Looking Across Treatment Modalities.