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

260 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Active Brains Programs for Cognitive Impairment and Chronic Pain in Aging Adults?

The Active Brains-Fitbit program, which is part of the Active Brains treatment, has shown improvements in physical, cognitive, and emotional functioning in older adults with chronic pain and cognitive decline. Participants in a related program who used Fitbits to track their activity reported better physical function and reduced anxiety. ^{1 2 3 4 5}

Is the Active Brains program safe for humans?

The Active Brains program, including its variations like Active Brains-Fitbit, has been tested in older adults with chronic pain and cognitive decline. The studies show it is feasible and acceptable, with improvements in physical, cognitive, and emotional functions, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is the Active Brains treatment different from other treatments for cognitive impairment and chronic pain in aging adults?

The Active Brains treatment is unique because it combines mind-body activities with gradual increases in walking, using either time goals or a Fitbit to track steps, specifically designed for older adults with chronic pain and cognitive decline. This approach is novel as it focuses on improving physical, cognitive, and emotional functions through remote delivery, making it accessible and feasible for participants. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. [2022]

2. United States 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. [2022]

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

Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. [2022]

4. Canada 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. [2023]

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

Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial. [2023]