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

Chronic Pain Clinical Trial

— iHOPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05782231
• Other study ID #: 2023P000362
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Older Adults (i.e., age >=55)

2. 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)

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Interpersonal Support Evaluation List (ISEL-12),	The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Pain Catastrophizing Scale (PCS)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	The Pain, Enjoyment of Life and General Activity scale (PEG)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Applied Mindfulness Process Scale (AMPS)	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	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Perceived Stress Scale (PSS-4)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Contrast Avoidance Questionnaire - Shortened (CAQ-S)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Patient Global Impression of Change (PGIC)	The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Tampa Scale for Kinesiophobia-11 (TSK11)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	UCLA-3 Loneliness Scale	The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Self-Compassion Scale - Short Form (SCS-SF)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Gratitude Questionnaire (GQ-6)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Measure of Current Status (MOCS)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Tobacco, Alcohol, Prescription medications, and other Substance (TAPS)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	The Everyday Discrimination Scale - Short (EDS-S)	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	PROMIS Sleep Disturbance - Short Form 6a v1.0;	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	The Pittsburgh Sleep Quality Index (PSQI)	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).	Baseline (0 weeks), Post-test (1 week after intervention completion)
Other	Qualitative Assesment	We will collect qualitative data from patients through exit interviews assessing perceptions of intervention.	Post-test (1 week after intervention completion)
Other	Pain, medication, and medical history questionnaire (PMMH)	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.	Post-test (1 week after intervention completion)
Primary	Feasibility of intervention completion	>=75 of patients approached agree to participate in intervention	10 weeks
Secondary	Physical function, performance-based	6-minute walk test (6MWT), assesses distance walked in 6 minutes.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	Physical function - objective	Average step count with ActiGraph GT3X-BTLE	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	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.	Baseline (0 weeks), Post-test (1 week after intervention completion)
Secondary	Acceptability	Satisfaction with or tolerability of the proposed approach >=75% of enrolled participants complete at least 8/10 sessions.	10 weeks
Secondary	Fidelity	>=75% of GetActive+ sessions components delivered as intended; 20% sessions rated	10 weeks