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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05782231

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Musculoskeletal Pain	Behavioral: GetActive+	N/A

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 disability spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or automatic 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 group in Spanish.

Baseline assessments and post-intervention assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: GetActive+ A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain	Behavioral: GetActive+ This is a 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.

Arm

Intervention/Treatment

Experimental: Experimental: GetActive+

A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain

Behavioral: GetActive+

This is a 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.

Outcome Measures

Primary Outcome Measures

Feasibility of intervention completion [10 weeks]
>=75 of patients approached agree to participate in intervention

Secondary Outcome Measures

Physical function, performance-based [Baseline (0 weeks), Post-test (1 week after intervention completion)]
6-minute walk test (6MWT), assesses distance walked 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 subscale [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.
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.
Physical function self-report [Baseline (0 weeks), Post-test (1 week after intervention completion)]
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b, self-report ability to engage in physical activities. Total summary score with Minimum = 8, Maximum = 40. Higher scores reflect greater physical function.
Acceptability [10 weeks]
Satisfaction with or tolerability of the proposed approach >=75% of enrolled participants complete at least 8/10 sessions.
Fidelity [10 weeks]
>=75% of GetActive+ sessions components delivered as intended; 20% sessions rated

Other Outcome Measures

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 questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing.
The 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. Minimum = 0, Maximum = 10. Higher scores indicate worse outcome.
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.
The 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) assess current Post Traumatic Stress Disorder symptoms. Higher scores are suggestive of difficulties with post-traumatic stress and further assessment and possibly referral for treatment is indicated.
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 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.
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 individual differences in the proneness to experience gratitude in daily life. Total summary of score with a Minimum = 6, Maximum = 42. Higher score indicating greater amount of gratitude.
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.
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.
The Everyday Discrimination Scale - Short (EDS-S) [Baseline (0 weeks), Post-test (1 week after intervention completion)]
The Everyday Discrimination Scale - Short (EDS-S) assesses experiences of discrimination. Responses are summed across items with a Minimum = 10, Maximum = 60. Higher scores indicate greater frequency of discriminatory experiences.
PROMIS Sleep Disturbance - Short Form 6a v1.0; [Baseline (0 weeks), Post-test (1 week after intervention completion)]
The PROMIS Sleep Disturbance - Short Form 6a v1.0 assesses quality of sleep. Sleep disturbance with a Minimum = 6, Maximum = 30. Higher scores indicate worse outcomes.
The Pittsburgh Sleep Quality Index (PSQI) [Baseline (0 weeks), Post-test (1 week after intervention completion)]
The Pittsburgh Sleep Quality Index (PSQI) is a single item (item 4) from PSQI assessing sleep duration with Minimum = 0 and Maximum = 24 (hour and minutes per night).
Qualitative Assesment [Post-test (1 week after intervention completion)]
We will collect qualitative data from patients through exit interviews assessing perceptions of intervention.
Pain, medication, and medical history questionnaire (PMMH) [Post-test (1 week after intervention completion)]
The Pain, medication, and medical history questionnaire (PMMH) assesses self-reported type of pain; pain location and number; pain treatments; pain medications; cannabis use for pain; medical comorbidities; mental health conditions and medication. There is no summary score, each item scored individually.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Older Adults (i.e., age >=55)
Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3); diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3-6 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