N/A
N=33
Improving Health for Older Adults With Pain Through Engagement (Open-pilot)
Chronic Pain · Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT05782231 ↗Enrolled (actual)
33
Serious AEs
9.1%
Results posted
May 2025
Primary outcome: Primary: Feasibility of Intervention Completion — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GetActive+ (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Intervention Completion |
33 | — |
| PRIMARY Acceptability |
31 | — |
| PRIMARY Fidelity of Session Components, As Rated by Clinicians |
1145 | — |
| SECONDARY Physical Function - Performance-based |
243.1; 277.0 | — |
| SECONDARY Physical Function - Objective |
2561.4; 2560.3 | — |
| SECONDARY Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales |
5.7; 4.4 | — |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) |
8.4; 5.7 | — |
| SECONDARY Generalized Anxiety Disorder Scale-7 (GAD-7); |
6.2; 5.1 | — |
| SECONDARY PROMIS Physical Function - Short Form 6b v2.0 |
38.7; 43.2 | — |
| SECONDARY The Interpersonal Support Evaluation List (ISEL-12), |
35.4; 36.5 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
20.6; 15.5; 7.3; 5.7; 4.2; 3.3 | — |
| SECONDARY Pain, Enjoyment of Life and General Activity Scale (PEG) |
6.0; 4.6; 6.5; 5.4; 5.5; 4.1 | — |
| SECONDARY Applied Mindfulness Process Scale (AMPS) |
37.4; 43.0 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) |
35.3; 36.0 | — |
| SECONDARY Perceived Stress Scale (PSS-4) |
6.7; 5.6 | — |
| SECONDARY Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form) |
12.5; 11.8 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration |
5.50; 6.23 | — |
| SECONDARY PROMIS Sleep Disturbance - Short Form 6a v1.0 |
55.6; 52.2 | — |
| SECONDARY Everyday Discrimination Scale - Short (EDS-S) |
2.9; 2.5 | — |
| SECONDARY Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS) |
32; 1; 0; 0; 0; 0 | — |
| SECONDARY Contrast Avoidance Questionnaire - Shortened (CAQ-S) |
13.7; 12.9 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
11; 7; 6; 5; 2; 0 | — |
| SECONDARY Tampa Scale for Kinesiophobia-11 (TSK11) |
28.9; 25.5 | — |
| SECONDARY UCLA-3 Loneliness Scale |
5.1; 4.8 | — |
| SECONDARY Measure of Current Status (MOCS) |
28.8; 32.0 | — |
| SECONDARY Self-Compassion Scale - Short Form (SCS-SF) |
3.4; 3.6 | — |
| SECONDARY Gratitude Questionnaire (GQ-6) |
35.00; 35.13 | — |
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/).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05782231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.