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

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropics, Pain medications

Disqualifiers: Dementia, Neurodegenerative disease, others

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs, Active Brains 1 and Active Brains 2, to evaluate their effectiveness in helping older adults with early memory issues and ongoing pain. Active Brains 1 teaches skills for relaxation, positive thinking, and mind-body connections, while Active Brains 2 provides lifestyle education without specific mind-body training. Both programs aim to enhance physical, mental, and emotional well-being and are delivered online. Individuals with non-cancerous chronic pain lasting more than three months and early memory problems might be suitable for this trial. As an unphased trial, this study presents a unique opportunity to explore innovative approaches to enhance well-being.

Will I have to stop taking my current medications?

The trial requires that you either be free of psychotropic or pain medication for at least 2 weeks before starting or be stable on your current medication for at least 6 weeks and willing to keep the dose the same.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Active Brains 1 program, which includes activities for both the mind and body, is generally easy for participants to handle. Previous studies have found that older adults in similar programs experienced improvements in physical health, thinking skills, and emotional well-being. No major negative effects were reported, indicating the program's safety for the intended group.

For the Active Brains 2 program, less direct evidence is available. However, since it involves lifestyle education and group support, it is expected to be just as well-tolerated. The program emphasizes public health advice, such as good nutrition and sleep, which also supports its safety.

Overall, both programs are designed to be manageable and helpful for older adults with early memory issues and ongoing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Active Brains programs because they offer a fresh approach to managing cognitive impairment and chronic pain in aging adults. Unlike standard treatments that often rely on medication, Active Brains 1 uses a holistic, multimodal strategy, integrating relaxation techniques, cognitive behavioral training, and mind-body interactions. This program not only teaches new skills but also encourages ongoing practice and lifestyle changes, potentially leading to sustainable improvements. Meanwhile, Active Brains 2 serves as a comparative tool, ensuring the benefits seen in Active Brains 1 are truly from the program's unique methods, not just general health advice. Both programs utilize a wrist-worn digital monitor to provide real-time feedback on physical activity, making them uniquely engaging and interactive.

What evidence suggests that this trial's treatments could be effective for cognitive impairment and chronic pain?

Research has shown that Active Brains 1, a program combining mind and body activities, can help older adults with chronic pain and memory issues improve their physical, mental, and emotional health. Studies have found that this program, which includes relaxation and thinking exercises, leads to noticeable improvements. Participants in earlier trials benefited from the program’s mix of exercises and technology, such as a wrist device that tracks physical activity. In this trial, some participants will receive Active Brains 1, while others will participate in Active Brains 2. Although less specific research exists on Active Brains 2, this program also aims to help with chronic pain and memory issues through lifestyle education. Both programs in this trial are designed to support better overall health and well-being in older adults facing these challenges. ^{1 2 3 5 6}

Who Is on the Research Team?

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 60 years old or older.

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

You have shown signs of memory and thinking problems.

Exclusion Criteria

You are currently thinking about harming yourself.

You exercise intensely for more than 30 minutes every day.

I regularly practice mindfulness for over 45 minutes a week or finished a cognitive therapy course recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either Active Brains 1 or Active Brains 2 programs, consisting of eight 90-minute sessions over 8 weeks delivered virtually via Zoom.

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for maintenance of improvements in outcomes through self-report questionnaires, a walk test, and a neuropsychological evaluation.

6 months

3 assessment points: baseline, post-program, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Active Brains 1
• Active Brains 2

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Brains 1 Experimental Treatment 1 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 2 Placebo Group 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The Active Brains (AB) program is being tested in a randomized clinical trial involving 260 older adults with chronic pain and early cognitive decline, aiming to improve physical, cognitive, and emotional functions compared to a control group.

Initial results show high participant retention and adherence, with 100% of participants completing baseline assessments and 93.48% adherence to activity monitoring devices, indicating the program's feasibility and potential for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial. Vranceanu, AM., Choukas, NR., Rochon, EA., et al.[2023]

The Active Brains-Fitbit (AB-F) program, a virtual intervention for older adults with chronic pain and cognitive decline, has shown promising feasibility and high participant adherence in its early stages, with 19 out of 21 participants completing baseline assessments and high attendance rates in sessions.

This pilot randomized controlled trial aims to evaluate the potential of AB-F to improve physical, emotional, and cognitive functions, marking a novel approach to treating comorbid chronic pain and cognitive decline in older adults during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study. Mace, RA., Doorley, JD., Popok, PJ., et al.[2023]

The Active Brains-Fitbit (AB-F) program, delivered remotely to older adults with chronic pain and cognitive decline, met feasibility benchmarks and showed preliminary improvements in physical, emotional, and cognitive functions after 8 weeks of participation.

In contrast, the Health Enhancement Program (HEP) educational control resulted in smaller or negligible improvements, highlighting the potential effectiveness of the AB-F intervention over standard educational approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study. Doorley, JD., Mace, RA., Popok, PJ., et al.[2022]

In a 10-week program involving 41 participants with chronic pain, using Fitbits to track activity led to significant increases in step count, with 30% of participants increasing their steps by over 800, and improvements in anxiety and self-reported physical function associated with meeting individualized step goals.

The study suggests that combining Fitbit tracking with a mind-body activity program can effectively promote physical activity and improve emotional and physical function in individuals with chronic pain, highlighting the potential of wearable technology in managing chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. Grunberg, VA., Greenberg, J., Mace, RA., et al.[2023]

A mixed-methods study involving 23 older adults with chronic pain and cognitive decline identified key themes related to their experiences and preferences for a new mind-body activity program aimed at increasing walking, highlighting the importance of tailored interventions.

Participants showed lower physical functioning compared to norms, but higher self-efficacy was linked to better cognitive, emotional, and physical functioning, suggesting that boosting self-efficacy could enhance the effectiveness of the proposed programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Mace, RA., Gates, MV., Bullard, B., et al.[2022]

Both mind-body activity programs, Active Brains and Active Brains-Fitbit, were feasible for older adults with chronic pain and cognitive decline, showing improvements in pain intensity, coping, physical function, and cognitive function among participants.

Participants expressed high satisfaction with both programs, indicating that these interventions could be beneficial for enhancing the quality of life in older adults facing chronic pain and cognitive challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Mace, RA., Gates, MV., Popok, PJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9372888/

Feasibility Randomized Controlled Trial of a Mind–Body ... We iteratively developed Active Brains–Fitbit (AB-F), a group mind–body activity program aided by a Fitbit that is feasible and associated with improvements in ...

2. researchprotocols.org researchprotocols.org/2021/1/e25351/

Live Video Adaptations to a Mind-Body Activity Program for ... We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34487167/

Feasibility Randomized Controlled Trial of a Mind-Body ... A group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning.

4. researchgate.net researchgate.net/publication/354412716_Feasibility_randomized_controlled_trial_of_a_mind-body_activity_program_for_older_adults_with_chronic_pain_and_cognitive_decline_The_virtual_Active_Brains_study

(PDF) Feasibility Randomized Controlled Trial of a Mind ... We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7813630/

Live Video Adaptations to a Mind-Body Activity Program for ... We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual ...

6. withpower.com withpower.com/trial/phase-chronic-pain-5-2022-248e7

Active Brains Programs for Cognitive Impairment and Chronic ... This trial compares two online programs designed to help older adults with early cognitive decline and chronic pain. The programs involve group sessions ...