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

Not Applicable

Completed

Conditions: Chronic Pain
Musculoskeletal Pain

Interventions: Behavioral: GetActive+

Registration Number: NCT05782231

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: GetActive+	GetActive+	A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Completion	10 weeks	\>=75 of patients approached agree to participate in intervention
Acceptability	10 weeks	\>=75% of enrolled participants complete at least 8/10 sessions
Fidelity of Session Components, As Rated by Clinicians	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%.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Physical Function - Performance-based	Baseline (0 weeks), Post-test (1 week after intervention completion)	6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes.
Physical Function - Objective	Baseline (0 weeks), Post-test (1 week after intervention completion)	Average step count with ActiGraph GT3X-BTLE
Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales	Baseline (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.
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)\>
PROMIS Physical Function - Short Form 6b v2.0	Baseline (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.
PROMIS Sleep Disturbance - Short Form 6a v1.0	Baseline (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.
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.
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.
Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration	Baseline (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.
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 Scale	Baseline (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.