GetActive+ Program for Chronic Pain

(iHOPE Trial)

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 10-week program called GetActive+ (a mind-body activity intervention) designed to help older adults manage chronic musculoskeletal pain through mind-body exercises and walking. Researchers aim to determine if this program can improve physical abilities, such as walking distance and step count, as well as emotional well-being, compared to usual care. Participants will share their experiences at the start, one week after the program ends, and six months later. The trial seeks older adults (55+) who have experienced musculoskeletal pain for more than three months and can walk for six minutes. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the GetActive+ program is safe for participants?

Research has shown that GetActive+, a mind-body program, builds on the success of an earlier program called GetActive. The original program reduced pain in adults without major safety issues. GetActive+ incorporates techniques such as mindfulness and cognitive behavioral skills to enhance physical and emotional well-being in older adults with chronic pain.

Although detailed safety information for GetActive+ is not yet available, its foundation on a well-accepted program suggests it may be safe for participants. Since GetActive+ employs non-invasive methods—like walking and mindfulness—serious risks are unlikely. Participants in similar programs have generally not reported major side effects. However, individual experiences can vary, so consulting a healthcare provider before joining is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic musculoskeletal pain that often rely on medications or physical therapy, the GetActive+ program is unique because it focuses on enhancing both physical and emotional well-being through a mind-body approach. This program is specifically designed for older adults, aiming to improve their overall function and quality of life by integrating techniques that address the psychological aspects of chronic pain. Researchers are excited about this treatment because it offers a holistic alternative that could potentially reduce dependence on medication and provide long-lasting relief by empowering individuals with self-management strategies.

What evidence suggests that the GetActive+ program is effective for chronic pain?

Research shows that the GetActive+ program, which combines mind-body exercises and walking, may help people with chronic pain feel better. In this trial, participants will either receive the GetActive+ program or continue with Treatment as Usual (TAU), which includes traditional primary care management of chronic pain. Studies have found that similar programs can improve both physical and emotional health in older adults. Participants in these studies noticed better pain management and increased physical activity. The program teaches skills to help change negative thoughts and behaviors. These early results suggest that GetActive+ might be an effective way to manage chronic pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for older adults (age >=55) with chronic musculoskeletal pain who can communicate in English or Spanish, are mentally able to participate, and can do a supervised walk test. They must not have untreated psychosis or substance issues, serious illnesses expected to worsen soon, or be unwilling to wear an activity tracking device.

Inclusion Criteria

I can walk for 6 minutes under supervision.

My pain level is moderate or higher.

Patient at Revere HealthCare Center who is cleared for participation by medical staff

Exclusion Criteria

I do not have a serious illness expected to worsen in the next 6 months.

I am willing and able to wear the ActiGraph device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-week mind-body and walking program (GetActive+) or receive treatment as usual (TAU)

10 weeks

Weekly sessions

Post-Intervention Assessment

Participants complete assessments including physical function, emotional function, and pain measures

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• GetActive+

Trial Overview

The study compares a 10-week mind-body and walking program called GetActive+ against usual treatment. It measures improvements in physical and emotional function using self-reports, performance tests like the six-minute walk test, step counts, and checks how well the program works and if it's accepted by participants.

How Is the Trial Designed?

Group I: GetActive+ Experimental Treatment 1 Intervention

A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain

Group II: Treatment as usual Active Control 1 Intervention

Treatment as Usual (TAU) includes traditional primary care management of chronic pain.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Behavioral activation (BA) shows promise as a treatment for chronic pain by encouraging individuals to engage in activities that align with their long-term goals, potentially breaking the cycle of pain, fear, and avoidance.

A case study of a veteran with chronic pain demonstrated that gradually increasing participation in previously avoided activities can improve both physical and emotional well-being, suggesting BA could be an effective therapeutic approach for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of behavioral activation in the treatment of chronic pain. Kim, EH., Crouch, TB., Olatunji, BO.[2018]

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]

Avoidance of activity in chronic pain patients is linked to increased pain, poorer psychological functioning, and greater physical disability, suggesting that avoiding activity may worsen overall health outcomes.

Engaging in activity endurance can improve physical and psychological functioning, but excessive activity (overactivity) may lead to negative outcomes, indicating that a balanced approach to activity is crucial for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity pacing, avoidance, endurance, and associations with patient functioning in chronic pain: a systematic review and meta-analysis. Andrews, NE., Strong, J., Meredith, PJ.[2022]

In a pilot study involving 82 participants with chronic pain, those engaged in a 10-week mind-body activity program reported high adherence to home practice, averaging about 30 days of physical activity and relaxation skills.

Longer durations of physical activity were significantly associated with reduced depression symptoms, suggesting that increasing physical activity may enhance emotional outcomes in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Practice Makes Perfect"? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program. Hopkins, SW., Greenberg, J., Isaacs, J., 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]

The GetActive-Fitbit program, a 10-week intervention combining mind-body skills and gradual activity increases, showed potential for improving physical and emotional health in adults with chronic pain, based on a small group of 4 participants.

Participants reported improvements in various outcomes, including physical function, emotional well-being, and pain coping strategies, suggesting that this program could be a credible and useful approach for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. Greenberg, J., Lin, A., Popok, PJ., et al.[2023]

The study evaluated the effectiveness of the 'Ikiiki Rehabilitation Notebook' combined with cognitive behavioral therapy (CBT) in 22 patients with intractable chronic pain, showing significant improvements in pain levels, daily activities, and quality of life after an average treatment period of 11.2 months.

Patients reported benefits such as improved presenteeism and participation in hobbies, indicating that this method may help educate patients about chronic pain management and encourage active engagement in exercise and social activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Exercise Facilitation Method in Combination with Cognitive Behavioral Therapy Using the Ikiiki Rehabilitation Notebook for Intractable Chronic Pain: Technical Report and 22 Cases. Kimura, S., Hosoi, M., Otsuru, N., et al.[2021]

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence suggests that exercise has few adverse effects, with most reported issues being mild soreness or muscle pain that subsided after a few weeks, indicating that exercise can be a safe option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence quality was low due to small sample sizes and short follow-up periods, but the interventions were generally safe, with few adverse events reported, primarily mild soreness or muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

A study involving 82 patients with chronic pain showed that two mind-body and activity interventions, with and without a Fitbit device, led to sustained improvements in coping strategies three months after the interventions ended.

Both interventions significantly enhanced coping measures such as pain-catastrophizing and mindfulness, indicating their effectiveness in helping patients manage chronic pain over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. Greenberg, J., Singh, T., Popok, PJ., et al.[2022]

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