Chronic PainiHOPENCT05782231
Improving Health for Older Adults With Pain Through Engagement (Open-pilot)
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 an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
- No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
- Ability to complete the 6-minute walk test under supervision of study staff
- Patient at Revere HealthCare Center who is cleared for participation by medical staff
- English or Spanish fluency
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 wear the ActiGraph device
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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 and post-intervention.
This study received support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).
Read the detailed description
The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended).
Our patients will be older adults with chronic pain from Revere HealthCare Center.
The GetActive+ program 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; body scan 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 an additional two groups in Spanish.
Baseline assessments and post-intervention assessments will include the six-minute walk test (6MWT), objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- GetActive+
- Keywords
- Older adults, Mind-body intervention, Chronic pain, 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
10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased 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+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Completion
>=75 of patients approached agree to participate in intervention
Measured: 10 weeks
Acceptability
>=75% of enrolled participants complete at least 8/10 sessions
Measured: 10 weeks
Fidelity of Session Components, As Rated by Clinicians
Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%.
Measured: Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period.
Secondary outcomes (24)
Physical Function - Performance-based
6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Physical Function - Objective
Average step count with ActiGraph GT3X-BTLE
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales
The Short Form Brief Pain Inventory (BPI) pain severity subscale assesses pain at its worst, least, average, and current. Minimum = 0, maximum = 10. Higher scores indicate worse outcome. The interference subscale assesses pain interference in the last 24 hours. Minimum = 0, maximum = 10. Higher scores indicate worse interference.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire (PHQ-8) is an assessment of depressive symptoms. Total summary score with Minimum = 0, Maximum = 24. Higher scores indicate worse outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Generalized Anxiety Disorder Scale-7 (GAD-7);
The Generalized Anxiety Disorder scale-7 (GAD-7) is an assessment of generalized anxiety symptoms. GAD-7 total score is obtained by adding the score for each of the items. Minimum = 0, Maximum = 21. Scores of 5-9 (mild), 10-14 (moderate), and 15-21 (severe) represent thresholds for mild, moderate, and severe anxiety. Higher scores indicate worse outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
PROMIS Physical Function - Short Form 6b v2.0
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b assesses one's ability to engage in physical activities. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the average (mean) physical function T score in the reference general population, with a standard deviation of 10. Higher T scores reflect greater physical function and ability to carry out physical activities.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
The Interpersonal Support Evaluation List (ISEL-12),
The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item measure that assesses hopelessness, helplessness and rumination about pain. Subscales (rumination, magnification, and helplessness) are calculated by summing item responses for the associated questions, and then combined (summed) to create the total score. Items range from 0-4, and total scores range from 0-52. For the subscales, rumination ranges from 0-16, magnification ranges from 0-12, and helplessness ranges from 0-24. Higher scores (on subscales and the scale as a whole) indicate higher levels of pain catastrophizing, i.e. higher scores indicate poorer outcomes. Both subscales and total score are shown here. The means reported reflect the mean of each subscale or total score among GetActive+ participants at the indicated timepoint.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pain, Enjoyment of Life and General Activity Scale (PEG)
The Pain, Enjoyment of Life and General Activity scale (PEG) rates a participant's pain intensity and related interference in enjoyment of life and general activity. Items are scored on a scale of 0-10, with 0 being no pain (or interference) and 10 being pain as bad as you can imagine (or complete interference). The total score is a sum of the three individual items (Pain Intensity Average, Activity Interference, Enjoyment Interference) divided by 3, with a minimum possible score of 0 and a maximum possible score of 10. Higher scores indicate worse outcomes (i.e. more pain intensity and interference). Scores presented here are the mean total score and mean item scores at the indicated timepoints.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Applied Mindfulness Process Scale (AMPS)
The Applied Mindfulness Process Scale (AMPS) assesses how participants use mindfulness when facing challenges in daily life. Sum all 15 items to obtain a total score ranging from 0-60. Higher scores indicate higher utilization of mindfulness
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) rates a participant's broad conceptualization of mindfulness,. Minimum = 12 Maximum = 48. Higher values reflect higher levels of mindfulness.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Perceived Stress Scale (PSS-4)
The Perceived Stress Scale (PSS-4) assesses stress perception levels. Total sum of scores. Minimum = 0 Maximum =16; Higher scores are correlated to more stress.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)
The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form) assesses current Post Traumatic Stress Disorder symptoms. Items in the measure are scored on a scale of 1-5, with 5 indicating being extremely bothered by a problem (related to stressful experiences) in the past month, and 1 indicating not being bothered at all. The total score is a sum of all item responses; this can range from 6 - 30. Higher scores are suggestive of difficulties with post-traumatic stress, and further assessment and possibly referral for treatment may be indicated especially if a score is 14 or more.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration
The Pittsburgh Sleep Quality Index (PSQI) is a four-question measure assessing sleep quality. This study ONLY utilized question 4 of the measure, which asks about sleep duration in hours and minutes per night (the time spent actually asleep, not just in bed). Reported below as an outcome is the mean hours of sleep reported by participants at baseline and posttest, i.e. the mean hours reported by participants as captured in Question 4 only of the PSQI measure.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
PROMIS Sleep Disturbance - Short Form 6a v1.0
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a v1.0 assesses quality of sleep. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Everyday Discrimination Scale - Short (EDS-S)
The Everyday Discrimination Scale - Short (EDS-S) assesses the frequency of experiences of discrimination. Each item is scored on a scale of 0-5, with 0 indicating never experiencing that situation, and 5 indicating experiencing it almost every day. Responses are then summed across items, with final scores ranging from 0 - 25. Higher scores indicate greater frequency of discriminatory experiences.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) assess substance use behaviors. No summary score. Each item is scored individually for each substance. For each item, higher scores indicate better outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Contrast Avoidance Questionnaire - Shortened (CAQ-S)
Contrast Avoidance Questionnaire - Shortened (CAQ-S) a measure of sustaining negative emotionality to protect against sudden shifts in emotion. Minimum = 8, Maximum = 40 with higher scores indicating worse outcomes.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Tampa Scale for Kinesiophobia-11 (TSK11)
The Tampa Scale for Kinesiophobia-11 (TSK11) is an 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
UCLA-3 Loneliness Scale
The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Measure of Current Status (MOCS)
The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Minimum = 0, maximum = 52. Higher scores indicate better outcome and a stronger ability to recognize stress and cope.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Self-Compassion Scale - Short Form (SCS-SF)
The Self-Compassion Scale - Short Form (SCS-SF) is the rate of a participant's amount of self-compassion. Scores are calculated by averaging the 12 items with Minimum = 1, Maximum = 5. Higher scores indicate worse outcome.
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Gratitude Questionnaire (GQ-6)
The Gratitude Questionnaire (GQ-6) assesses the proneness to experience gratitude in daily life. All items individual items are scored from 1=strongly disagree to 7=strongly agree. The total score is a sum of all the items, with a minimum of 6 and maximum of 42. Higher scores indicate a greater amount of gratitude. Results are reported for baseline and posttest (timepoint indicated by the row title description)>
Measured: Baseline (0 weeks), Post-test (1 week after intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start18 Apr 2023
- Primary completion12 Dec 2023
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782231
- Sponsor's protocol ID
- 2023P000362
- Acronym
- iHOPE
- Status last verified
- May 2025
- First submitted
- 23 Feb 2023
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be accessed in the Vivli data repository
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 33971485McDermott K, Levey N, Brewer J, Ehmann M, Hooker JE, Pasinski R, Yousif N, Raju V, Gholston M, Greenberg J, Ritchie CS, Vranceanu AM. Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic. JMIR Res Protoc. 2023 Dec 29;12:e52117. doi: 10.2196/52117.
PubMed 38157234
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
- ClinicalTrials.gov ID
- NCT05782231
- Acronym / sponsor ID
- iHOPE / 2023P000362
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- Older adults, Mind-body intervention, Chronic pain, Community health center, Physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Posted 15 May 2025
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 an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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 and post-intervention.
This study received support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).
Detailed description
The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended).
Our patients will be older adults with chronic pain from Revere HealthCare Center.
The GetActive+ program 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; body scan 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 an additional two groups in Spanish.
Baseline assessments and post-intervention assessments will include the six-minute walk test (6MWT), objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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)
- No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
Key exclusion criteria (2 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 wear the ActiGraph device
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+10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location. | Behavioural | GetActive+ |
Primary outcome
Feasibility of Intervention Completion
Time frame: 10 weeks
>=75 of patients approached agree to participate in intervention
Acceptability
Time frame: 10 weeks
>=75% of enrolled participants complete at least 8/10 sessions
Fidelity of Session Components, As Rated by Clinicians
Time frame: Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period.
Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%.
24 secondary outcomes
Physical Function - Performance-based
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Physical Function - Objective
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Generalized Anxiety Disorder Scale-7 (GAD-7);
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
PROMIS Physical Function - Short Form 6b v2.0
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
The Interpersonal Support Evaluation List (ISEL-12),
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pain, Enjoyment of Life and General Activity Scale (PEG)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Applied Mindfulness Process Scale (AMPS)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Perceived Stress Scale (PSS-4)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
PROMIS Sleep Disturbance - Short Form 6a v1.0
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Everyday Discrimination Scale - Short (EDS-S)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Contrast Avoidance Questionnaire - Shortened (CAQ-S)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Patient Global Impression of Change (PGIC)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Tampa Scale for Kinesiophobia-11 (TSK11)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
UCLA-3 Loneliness Scale
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Measure of Current Status (MOCS)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Self-Compassion Scale - Short Form (SCS-SF)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Gratitude Questionnaire (GQ-6)
Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: PubMed 38157234McDermott K, Levey N, Brewer J, Ehmann M, Hooker JE, Pasinski R, Yousif N, Raju V, Gholston M, Greenberg J, Ritchie CS, Vranceanu AM. Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic. JMIR Res Protoc. 2023 Dec 29;12:e52117. doi: 10.2196/52117.
- Individual participant dataSharing planned: Yes. Data can be accessed in the Vivli data repository
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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. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 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?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Completion (time frame: 10 weeks). The study lists 3 primary outcomes in all. 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 NCT05782231, 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 15 May 2025.