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Improving Health for Older Adults With Pain Through Engagement (Open-pilot)

Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05782231
Acronym
iHOPE
Enrollment
33
Registered
2023-03-23
Start date
2023-04-18
Completion date
2024-03-05
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Musculoskeletal Pain

Keywords

Older adults, Mind-body intervention, Chronic pain, Community health center, Physical function

Brief 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. 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.

Interventions

BEHAVIORALGetActive+

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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Older Adults (i.e., age \>=55) 2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain \> 3 months) 3. Pain score \>=4 (moderate) on the Numerical Rating Scale 4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \<4 errors) 5. No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study 6. Ability to complete the 6-minute walk test under supervision of study staff 7. Patient at Revere HealthCare Center who is cleared for participation by medical staff 8. English or Spanish fluency

Exclusion criteria

1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer) 2. Individuals who are unwilling or unable to wear the ActiGraph device

Design outcomes

Primary

MeasureTime frameDescription
Fidelity of Session Components, As Rated by CliniciansFidelity, 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%.
Feasibility of Intervention Completion10 weeks\>=75 of patients approached agree to participate in intervention
Acceptability10 weeks\>=75% of enrolled participants complete at least 8/10 sessions

Secondary

MeasureTime frameDescription
Short Form Brief Pain Inventory (BPI) Pain Severity and Interference SubscalesBaseline (0 weeks), Post-test (1 week after intervention completion)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.
Patient Health Questionnaire-8 (PHQ-8)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Generalized Anxiety Disorder Scale-7 (GAD-7);Baseline (0 weeks), Post-test (1 week after intervention completion)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.
PROMIS Physical Function - Short Form 6b v2.0Baseline (0 weeks), Post-test (1 week after intervention completion)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.
The Interpersonal Support Evaluation List (ISEL-12),Baseline (0 weeks), Post-test (1 week after intervention completion)The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome.
Pain Catastrophizing Scale (PCS)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Pain, Enjoyment of Life and General Activity Scale (PEG)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Applied Mindfulness Process Scale (AMPS)Baseline (0 weeks), Post-test (1 week after intervention completion)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
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Perceived Stress Scale (PSS-4)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
PROMIS Sleep Disturbance - Short Form 6a v1.0Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Everyday Discrimination Scale - Short (EDS-S)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Contrast Avoidance Questionnaire - Shortened (CAQ-S)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Patient Global Impression of Change (PGIC)Baseline (0 weeks), Post-test (1 week after intervention completion)The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome.
Tampa Scale for Kinesiophobia-11 (TSK11)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
UCLA-3 Loneliness ScaleBaseline (0 weeks), Post-test (1 week after intervention completion)The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome.
Measure of Current Status (MOCS)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Self-Compassion Scale - Short Form (SCS-SF)Baseline (0 weeks), Post-test (1 week after intervention completion)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.
Gratitude Questionnaire (GQ-6)Baseline (0 weeks), Post-test (1 week after intervention completion)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)\>
Pittsburgh Sleep Quality Index (PSQI) - Sleep DurationBaseline (0 weeks), Post-test (1 week after intervention completion)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.
Physical Function - Performance-basedBaseline (0 weeks), Post-test (1 week after intervention completion)6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes.
Physical Function - ObjectiveBaseline (0 weeks), Post-test (1 week after intervention completion)Average step count with ActiGraph GT3X-BTLE

Other

MeasureTime frameDescription
Qualitative Assessment of Intervention by ParticipantsPost-test (1 week after intervention completion)Qualitative information was collected from patients through one-on-one exit interviews assessing perceptions of intervention; these were completely qualitative (i.e. held through discussions and not by using surveys or structured questions, etc). The reported result is the number of participants who completed this optional exit interview after intervention completion.

Countries

United States

Participant flow

Recruitment details

Recruitment was facilitated through posted Massachusetts General Hospital (MGH) Institutional Review Board-approved flyers in the clinic and the hospital's research recruitment site, and referrals from MGH Revere HealthCare Center physicians, nurses, psychologists, and other relevant staff.

Pre-assignment details

All enrolled participants were assigned to the intervention, GetActive+.

Participants by arm

ArmCount
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.
33
Total33

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicGetActive+
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
21 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Age, Continuous67.76 years
STANDARD_DEVIATION 8.65
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants
Race (NIH/OMB)
White
14 Participants
Region of Enrollment
United States
33 participants
Sex: Female, Male
Female
28 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 33
other
Total, other adverse events
17 / 33
serious
Total, serious adverse events
3 / 33

Outcome results

Primary

Acceptability

\>=75% of enrolled participants complete at least 8/10 sessions

Time frame: 10 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Experimental: GetActive+Acceptability31 Participants
Primary

Feasibility of Intervention Completion

\>=75 of patients approached agree to participate in intervention

Time frame: 10 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Experimental: GetActive+Feasibility of Intervention Completion33 Participants
Primary

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%.

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.

ArmMeasureValue (COUNT_OF_UNITS)
Experimental: GetActive+Fidelity of Session Components, As Rated by Clinicians1145 Number of session components
Secondary

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

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Applied Mindfulness Process Scale (AMPS)Baseline37.4 units on a scaleStandard Deviation 12.9
Experimental: GetActive+Applied Mindfulness Process Scale (AMPS)Post-test43.0 units on a scaleStandard Deviation 9.7
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)Baseline35.3 units on a scaleStandard Deviation 7.2
Experimental: GetActive+Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)Post-test36.0 units on a scaleStandard Deviation 6
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Contrast Avoidance Questionnaire - Shortened (CAQ-S)Post-test12.9 units on a scaleStandard Deviation 4.9
Experimental: GetActive+Contrast Avoidance Questionnaire - Shortened (CAQ-S)Baseline13.7 units on a scaleStandard Deviation 6.1
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Everyday Discrimination Scale - Short (EDS-S)Baseline2.9 units on a scaleStandard Deviation 3.5
Experimental: GetActive+Everyday Discrimination Scale - Short (EDS-S)Post-test2.5 units on a scaleStandard Deviation 2.9
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Generalized Anxiety Disorder Scale-7 (GAD-7);Baseline6.2 units on a scaleStandard Deviation 5.4
Experimental: GetActive+Generalized Anxiety Disorder Scale-7 (GAD-7);Post-test5.1 units on a scaleStandard Deviation 4.2
Secondary

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)\>

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Gratitude Questionnaire (GQ-6)Baseline35.00 score on a scaleStandard Deviation 5.66
Experimental: GetActive+Gratitude Questionnaire (GQ-6)Posttest35.13 score on a scaleStandard Deviation 5.73
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Measure of Current Status (MOCS)Baseline28.8 units on a scaleStandard Deviation 9.8
Experimental: GetActive+Measure of Current Status (MOCS)Post-test32.0 units on a scaleStandard Deviation 9.4
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Total Score - Baseline20.6 score on a scaleStandard Deviation 14.5
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Total score - Post-test15.5 score on a scaleStandard Deviation 11.4
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Rumination- Baseline7.3 score on a scaleStandard Deviation 5
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Rumination- Post-test5.7 score on a scaleStandard Deviation 4.1
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Magnification - Baseline4.2 score on a scaleStandard Deviation 3.8
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Magnification - Post-test3.3 score on a scaleStandard Deviation 2.7
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Helplessness - Baseline9.1 score on a scaleStandard Deviation 6.7
Experimental: GetActive+Pain Catastrophizing Scale (PCS)Helplessness - Post-test6.6 score on a scaleStandard Deviation 5.4
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Total Score (Baseline)6.0 score on a scaleStandard Deviation 2.2
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Total Score (Posttest)4.6 score on a scaleStandard Deviation 2.6
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Average Pain Intensity (Baseline)6.5 score on a scaleStandard Deviation 1.8
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Average Pain Intensity (Posttest)5.4 score on a scaleStandard Deviation 2.4
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Activity Interference (Baseline)5.5 score on a scaleStandard Deviation 2.9
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Activity Interference (Posttest)4.1 score on a scaleStandard Deviation 3
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Enjoyment Interference (Baseline)5.8 score on a scaleStandard Deviation 2.7
Experimental: GetActive+Pain, Enjoyment of Life and General Activity Scale (PEG)Enjoyment Interference (Posttest)3.8 score on a scaleStandard Deviation 3
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Experimental: GetActive+Patient Global Impression of Change (PGIC)Very much improved11 Participants
Experimental: GetActive+Patient Global Impression of Change (PGIC)Much improved7 Participants
Experimental: GetActive+Patient Global Impression of Change (PGIC)Minimally improved6 Participants
Experimental: GetActive+Patient Global Impression of Change (PGIC)No change5 Participants
Experimental: GetActive+Patient Global Impression of Change (PGIC)Minimally worse2 Participants
Experimental: GetActive+Patient Global Impression of Change (PGIC)Much worse or very much worse0 Participants
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Patient Health Questionnaire-8 (PHQ-8)Baseline8.4 units on a scaleStandard Deviation 6
Experimental: GetActive+Patient Health Questionnaire-8 (PHQ-8)Post-test5.7 units on a scaleStandard Deviation 6.1
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Perceived Stress Scale (PSS-4)Baseline6.7 units on a scaleStandard Deviation 2
Experimental: GetActive+Perceived Stress Scale (PSS-4)Post-test5.6 units on a scaleStandard Deviation 2.7
Secondary

Physical Function - Objective

Average step count with ActiGraph GT3X-BTLE

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Physical Function - ObjectiveBaseline2561.4 stepsStandard Deviation 2013.4
Experimental: GetActive+Physical Function - ObjectivePost-test2560.3 stepsStandard Deviation 1797.7
Secondary

Physical Function - Performance-based

6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Physical Function - Performance-basedBaseline243.1 metersStandard Deviation 82.6
Experimental: GetActive+Physical Function - Performance-basedPost-test277.0 metersStandard Deviation 77.8
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

Population: 23 participants provided this information at baseline, but only 19 participants provided it at posttest.

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Pittsburgh Sleep Quality Index (PSQI) - Sleep DurationBaseline5.50 hoursStandard Deviation 1.98
Experimental: GetActive+Pittsburgh Sleep Quality Index (PSQI) - Sleep DurationPosttest6.23 hoursStandard Deviation 2.14
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)Baseline12.5 units on a scaleStandard Deviation 5.4
Experimental: GetActive+Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)Post-test11.8 units on a scaleStandard Deviation 6
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+PROMIS Physical Function - Short Form 6b v2.0Baseline38.7 T scoreStandard Deviation 7.3
Experimental: GetActive+PROMIS Physical Function - Short Form 6b v2.0Post-test43.2 T scoreStandard Deviation 8.7
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+PROMIS Sleep Disturbance - Short Form 6a v1.0Baseline55.6 T-scoreStandard Deviation 9.3
Experimental: GetActive+PROMIS Sleep Disturbance - Short Form 6a v1.0Post-test52.2 T-scoreStandard Deviation 9.9
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Self-Compassion Scale - Short Form (SCS-SF)Baseline3.4 units on a scaleStandard Deviation 0.7
Experimental: GetActive+Self-Compassion Scale - Short Form (SCS-SF)Post-test3.6 units on a scaleStandard Deviation 0.8
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Short Form Brief Pain Inventory (BPI) Pain Severity and Interference SubscalesBaseline5.7 units on a scaleStandard Deviation 1.8
Experimental: GetActive+Short Form Brief Pain Inventory (BPI) Pain Severity and Interference SubscalesPost-test4.4 units on a scaleStandard Deviation 2.3
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+Tampa Scale for Kinesiophobia-11 (TSK11)Baseline28.9 units on a scaleStandard Deviation 6.7
Experimental: GetActive+Tampa Scale for Kinesiophobia-11 (TSK11)Post-test25.5 units on a scaleStandard Deviation 5.9
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+The Interpersonal Support Evaluation List (ISEL-12),Baseline35.4 units on a scaleStandard Deviation 7.8
Experimental: GetActive+The Interpersonal Support Evaluation List (ISEL-12),Post-test36.5 units on a scaleStandard Deviation 7.1
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UseNever32 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UseLess than monthly1 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UseMonthly0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UseWeekly0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UseDaily or almost daily0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Tobacco UsePrefer not to respond0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingNever23 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingLess than monthly3 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingMonthly4 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingWeekly0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingDaily or almost daily0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Binge DrinkingPrefer not to respond3 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UseNever31 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UseLess than monthly2 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UseMonthly0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UseWeekly0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UseDaily or almost daily0 Participants
Experimental: GetActive+Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)Prescription Drug UsePrefer not to respond0 Participants
Secondary

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.

Time frame: Baseline (0 weeks), Post-test (1 week after intervention completion)

ArmMeasureGroupValue (MEAN)Dispersion
Experimental: GetActive+UCLA-3 Loneliness ScaleBaseline5.1 units on a scaleStandard Deviation 2
Experimental: GetActive+UCLA-3 Loneliness ScalePost-test4.8 units on a scaleStandard Deviation 1.8
Other Pre-specified

Qualitative Assessment of Intervention by Participants

Qualitative information was collected from patients through one-on-one exit interviews assessing perceptions of intervention; these were completely qualitative (i.e. held through discussions and not by using surveys or structured questions, etc). The reported result is the number of participants who completed this optional exit interview after intervention completion.

Time frame: Post-test (1 week after intervention completion)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Experimental: GetActive+Qualitative Assessment of Intervention by Participants32 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026