GetActive+ Program for Chronic Pain

(iHOPE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Suicidality, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up. This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

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 data supports the effectiveness of the GetActive+ Mind-Body Activity Intervention treatment for chronic pain?

Research shows that participants in a similar mind-body program reported improvements in physical and emotional function, including reduced depression symptoms, when they engaged in regular physical activity. This suggests that the GetActive+ program, which includes mind-body skills and gradual activity increases, may help improve physical and emotional well-being in people with chronic pain. ^{1 2 3 4 5}

Is the GetActive+ Program for Chronic Pain safe for humans?

The GetActive+ Program, which includes mind-body activities and gradual increases in physical activity, has been shown to be credible and useful, with potential improvements in physical and emotional function among participants with chronic pain. There is no specific mention of safety concerns in the available research, suggesting it is generally safe for humans. ^{1 3 4 6 7}

How is the GetActive+ treatment different from other treatments for chronic pain?

The GetActive+ treatment is unique because it combines mind-body skills, pain coping strategies, and gradual increases in physical activity, often supported by a digital monitoring device like a Fitbit, to improve both physical and emotional health in chronic pain patients. This approach emphasizes home practice and integrates mindfulness and gratitude exercises, which are not typically included in standard chronic pain treatments. ^{1 4 8 9 10}

Research Team

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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 am fluent in English or Spanish.

I can walk for 6 minutes under supervision.

My pain level is moderate or higher.

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.

Trial Timeline

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

Treatment Details

Interventions

• GetActive+ (Behavioral Intervention)

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.

Participant Groups

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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. [2022]

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

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

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

Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. [2023]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]

8. Switzerland 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. [2021]

9. 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]

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

Adaptation of behavioral activation in the treatment of chronic pain. [2018]