search
Back to results

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

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GetActive+
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Older adults, Mind-body intervention, Chronic pain, Community health center, Physical function

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Older Adults (i.e., age >=55) Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months); 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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: GetActive+

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of intervention completion
>=75 of patients approached agree to participate in intervention

Secondary Outcome Measures

Physical function, performance-based
6-minute walk test (6MWT), assesses distance walked in 6 minutes.
Physical function - objective
Average step count with ActiGraph GT3X-BTLE
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.
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.
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.
Physical function self-report
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
Satisfaction with or tolerability of the proposed approach >=75% of enrolled participants complete at least 8/10 sessions.
Fidelity
>=75% of GetActive+ sessions components delivered as intended; 20% sessions rated

Full Information

First Posted
February 23, 2023
Last Updated
July 27, 2023
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05782231
Brief Title
Improving Health for Older Adults With Pain Through Engagement (Open-pilot)
Acronym
iHOPE
Official Title
Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
Older adults, Mind-body intervention, Chronic pain, Community health center, Physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: GetActive+
Arm Type
Experimental
Arm Description
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
Intervention Type
Behavioral
Intervention Name(s)
GetActive+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention completion
Description
>=75 of patients approached agree to participate in intervention
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Physical function, performance-based
Description
6-minute walk test (6MWT), assesses distance walked in 6 minutes.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Physical function - objective
Description
Average step count with ActiGraph GT3X-BTLE
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Short Form Brief Pain Inventory (BPI) pain severity and interference subscales
Description
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)
Title
Patient Health Questionnaire-8 (PHQ-8)
Description
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)
Title
Generalized Anxiety Disorder scale-7 (GAD-7);
Description
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)
Title
Physical function self-report
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Acceptability
Description
Satisfaction with or tolerability of the proposed approach >=75% of enrolled participants complete at least 8/10 sessions.
Time Frame
10 weeks
Title
Fidelity
Description
>=75% of GetActive+ sessions components delivered as intended; 20% sessions rated
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
The Interpersonal Support Evaluation List (ISEL-12),
Description
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)
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
The Pain, Enjoyment of Life and General Activity scale (PEG)
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Applied Mindfulness Process Scale (AMPS)
Description
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)
Title
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Description
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)
Title
Perceived Stress Scale (PSS-4)
Description
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)
Title
The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form)
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Contrast Avoidance Questionnaire - Shortened (CAQ-S)
Description
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)
Title
Patient Global Impression of Change (PGIC)
Description
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)
Title
Tampa Scale for Kinesiophobia-11 (TSK11)
Description
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)
Title
UCLA-3 Loneliness Scale
Description
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)
Title
Self-Compassion Scale - Short Form (SCS-SF)
Description
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)
Title
Gratitude Questionnaire (GQ-6)
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Measure of Current Status (MOCS)
Description
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)
Title
Tobacco, Alcohol, Prescription medications, and other Substance (TAPS)
Description
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)
Title
The Everyday Discrimination Scale - Short (EDS-S)
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
PROMIS Sleep Disturbance - Short Form 6a v1.0;
Description
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.
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
The Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Time Frame
Baseline (0 weeks), Post-test (1 week after intervention completion)
Title
Qualitative Assesment
Description
We will collect qualitative data from patients through exit interviews assessing perceptions of intervention.
Time Frame
Post-test (1 week after intervention completion)
Title
Pain, medication, and medical history questionnaire (PMMH)
Description
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.
Time Frame
Post-test (1 week after intervention completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older Adults (i.e., age >=55) Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months); 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
617-724-4977
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Ritchie, MD, MPH
Phone
617-726-1382
Email
critchie@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Phone
617-724-4977
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christine Ritchie, MD, MPH
Phone
6177261382
Email
critchie@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33469845
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.
Results Reference
background
PubMed Identifier
35914640
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.
Results Reference
background
PubMed Identifier
33971485
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs