Clinical trial NCT05782231: Improving Health for Older Adults With Pain Through Engagement (Open-pilot)
Official title: Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: Older adults
Mind-body intervention
Chronic pain
Community health center
Physical function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 33
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Intervention Completion
timeFrame: 10 weeks
measure: Acceptability
timeFrame: 10 weeks
measure: Fidelity of Session Components, As Rated by Clinicians
timeFrame: 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:
measure: Physical Function - Performance-based
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Physical Function - Objective
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Generalized Anxiety Disorder Scale-7 (GAD-7);
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: PROMIS Physical Function - Short Form 6b v2.0
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: The Interpersonal Support Evaluation List (ISEL-12),
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Pain, Enjoyment of Life and General Activity Scale (PEG)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Applied Mindfulness Process Scale (AMPS)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Perceived Stress Scale (PSS-4)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: PROMIS Sleep Disturbance - Short Form 6a v1.0
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Everyday Discrimination Scale - Short (EDS-S)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Contrast Avoidance Questionnaire - Shortened (CAQ-S)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Tampa Scale for Kinesiophobia-11 (TSK11)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: UCLA-3 Loneliness Scale
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Measure of Current Status (MOCS)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
measure: Gratitude Questionnaire (GQ-6)
timeFrame: Baseline (0 weeks), Post-test (1 week after intervention completion)
Other outcomes:
measure: Qualitative Assessment of Intervention by Participants
timeFrame: Post-test (1 week after intervention completion)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grunberg 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.
citation: Popok 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.
citation: McDermott 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.