Chronic PainiHOPENCT06119698
Improving Health for Older Adults With Pain Through Engagement
A study testing GetActive+ in people with Chronic Pain and Musculoskeletal Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- GetActive+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older Adults (i.e., age >=55)
- Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months)
- Pain score >=4 (moderate) on the Numerical Rating Scale
- Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., <4 errors)
- Self-reported ability to complete the 6-minute walk test including with assistive devices
- Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
- English or Spanish fluency and literacy
Who cannot join
- Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
- Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch
- Active suicidal ideation with plan or intent
- Active and untreated serious mental health or substance use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ana-Maria Vranceanu, PhD, 617-724-4977, avranceanu@mgh.harvard.edu
Christine Ritchie, MD, MPH, 617-726-1382, critchie@mgh.harvard.edu
About this study
Official title: Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study
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/).
Read the detailed description
The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes.
Aim 1: Self-reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months.
Aim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and organization levels based on Proctor's implementation framework.
The investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere. The GetActive+ program used in the Randomized Controlled Trial (RCT) will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids); 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; progressive muscle relaxation to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between-session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with additional groups in Spanish.
Baseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness while accounting for clinical, demographic, and social determinants of health.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- GetActive+
- Keywords
- Older adults, Mind-body intervention, Chronic pain, ActiGraph, Community health center, Physical function
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetActive+Behavioural
This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
| Study group | Role | What they receive |
|---|---|---|
| GetActive+ | Experimental | A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain Receives: Behavioral: GetActive+ |
| Treatment as usual | No intervention | Treatment as Usual (TAU) includes traditional primary care management of chronic pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function - self-report
Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.
Secondary outcomes (7)
Physical function - objective
Average step count with wrist-worn ActiGraph wGT3X-BT; collects average step count for 4-7 days.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Physical function - performance-based
6-minute walk test (6MWT); measures the total distance in meters covered by an individual in 6 minutes, with greater distances covered indicating better physical function.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity and Severity
Brief Pain Inventory - Short Form (BPI-SF); assesses pain severity and interference. Scores range from 0 to 10, with higher scores indicating more severe pain severity or interference.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity and Interference
Pain, Enjoyment of Life and General Activity (PEG) Scale; measures pain intensity and pain interference in the enjoyment of life and activities of daily living. Scores range from 0 to 10, with higher scores indicating more severe pain and related interference.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Depression
Patient Health Questionnaire - 8 (PHQ-8); assesses depressive symptoms. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Anxiety
Generalized Anxiety Disorder - 7 (GAD-7); measures anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Measured: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Impression of Change
Patient Global Impression of Change (PGIC); assesses subjective changes in response to the intervention. Scores range from 0 to 6, with higher scores indicating worse outcomes.
Measured: Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Oct 2024
- Primary completion1 Apr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General HospitalChristine Ritchie, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119698
- Sponsor's protocol ID
- 2024P000782
- Acronym
- iHOPE
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data file (e.g., blinded Excel with raw scores at each time point) Data dictionary Detailed protocol Analysis plan
Publications
Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.
PubMed 33469845Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29.
PubMed 35914640Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2.
PubMed 33971485Vonderheide C, Kilduff C, McDermott KA, Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M; iHOPE Study Team; Ritchie CS, Vranceanu AM. Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study. Contemp Clin Trials. 2025 Dec;159:108116. doi: 10.1016/j.cct.2025.108116. Epub 2025 Oct 24.
PubMed 41326265
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study
- ClinicalTrials.gov ID
- NCT06119698
- Acronym / sponsor ID
- iHOPE / 2024P000782
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- Older adults, Mind-body intervention, Chronic pain, ActiGraph, Community health center, Physical function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/).
Detailed description
The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes.
Aim 1: Self-reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months.
Aim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and organization levels based on Proctor's implementation framework.
The investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere. The GetActive+ program used in the Randomized Controlled Trial (RCT) will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids); 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; progressive muscle relaxation to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between-session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with additional groups in Spanish.
Baseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness while accounting for clinical, demographic, and social determinants of health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GetActive+ | Experimental | Behavioral: GetActive+A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain |
| Treatment as usual | No intervention | –Treatment as Usual (TAU) includes traditional primary care management of chronic pain. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older Adults (i.e., age >=55)
- Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months)
- Pain score >=4 (moderate) on the Numerical Rating Scale
- Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., <4 errors)
- Self-reported ability to complete the 6-minute walk test including with assistive devices
Key exclusion criteria (4 listed)
- Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
- Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch
- Active suicidal ideation with plan or intent
- Active and untreated serious mental health or substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetActive+This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location. | Behavioural | GetActive+ |
Primary outcome
Physical function - self-report
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.
7 secondary outcomes
Physical function - objective
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Physical function - performance-based
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity and Severity
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity and Interference
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Depression
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Anxiety
Time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Impression of Change
Time frame: Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 33469845Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.
- Background: PubMed 35914640Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29.
- Background: PubMed 33971485Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2.
- Derived from this study: PubMed 41326265Vonderheide C, Kilduff C, McDermott KA, Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M; iHOPE Study Team; Ritchie CS, Vranceanu AM. Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study. Contemp Clin Trials. 2025 Dec;159:108116. doi: 10.1016/j.cct.2025.108116. Epub 2025 Oct 24.
- Individual participant dataSharing planned: Yes. Data file (e.g., blinded Excel with raw scores at each time point) Data dictionary Detailed protocol Analysis plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
Christine Ritchie, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetActive+ in people with Chronic Pain and Musculoskeletal Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana-Maria Vranceanu, PhD (617-724-4977, avranceanu@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function - self-report (time frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119698, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.