Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain

2021 ◽  
Author(s):  
Jonathan Greenberg ◽  
Ann Lin ◽  
Paula J. Popok ◽  
Ronald J. Kulich ◽  
Robert R. Edwards ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Case Illustration ◽  
Activity Program ◽  
Group Mind

Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual “Active Brains” study

2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
A Priori ◽  
Exit Interviews ◽  
Randomized Controlled ◽  
Activity Program ◽  
Body Activity

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

scholarly journals A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial

10.2196/18703 ◽  
2020 ◽  
Vol 4 (6) ◽  
pp. e18703 ◽  
Author(s):  
Jonathan Greenberg ◽  
Paula J Popok ◽  
Ann Lin ◽  
Ronald J Kulich ◽  
Peter James ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Physical Function ◽  
Effect Size ◽  
Controlled Trial ◽  
Walk Test ◽  
Randomized Controlled ◽  
Emotional Function ◽  
Activity Program ◽  
Digital Monitoring ◽  
Objectively Measured

Background Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. Objective This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. Methods Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. Results Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. Conclusions These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. Trial Registration ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916

scholarly journals Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

10.2196/25351 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e25351
Author(s):  
Ryan A Mace ◽  
James D Doorley ◽  
Paula J Popok ◽  
Ana-Maria Vranceanu
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Cognitive Decline ◽  
Cognitive Functions ◽  
Self Report ◽  
Treatment Manual ◽  
Pain Clinic ◽  
Live Video ◽  
Activity Program ◽  
Body Activity

Background Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID) DERR1-10.2196/25351

scholarly journals A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jonathan Greenberg ◽  
Paula J Popok ◽  
Ann Lin ◽  
Ronald J Kulich ◽  
Peter James ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Physical Function ◽  
Effect Size ◽  
Controlled Trial ◽  
Walk Test ◽  
Randomized Controlled ◽  
Emotional Function ◽  
Activity Program ◽  
Digital Monitoring ◽  
Objectively Measured

BACKGROUND Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (<i>GetActive</i>) with and without a digital monitoring device (<i>GetActive-Fitbit</i>), which were iteratively refined through mixed methods. METHODS Patients with chronic pain were randomized to the <i>GetActive</i> (n=41) or <i>GetActive-Fitbit</i> (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; <i>P</i>&lt;.001; effect size of 0.99 SD units for the <i>GetActive</i> group and mean increase=+50 m, SD 58.63; <i>P</i>&lt;.001; effect size of 0.85 SD units for the <i>GetActive-Fitbit</i> group) and self-reported physical function (<i>P</i>=.001; effect size of 0.62 SD units for the <i>GetActive</i> group and <i>P</i>=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the <i>GetActive</i> group and +867 steps for the <i>GetActive-Fitbit</i> group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the <i>GetActive-Fitbit</i> group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. CLINICALTRIAL ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916

scholarly journals Development And Early Feasibility Testing Of A Mind-Body Physical Activity Program For Patients With Heterogeneous Chronic Pain; The GetActive Study

2019 ◽  
Vol Volume 12 ◽  
pp. 3279-3297 ◽  
Author(s):  
Jonathan Greenberg ◽  
Ann Lin ◽  
Emily Zale ◽  
Ronald J Kulich ◽  
Peter James ◽  
...  
Keyword(s):  
Physical Activity ◽  
Chronic Pain ◽  
Physical Activity Program ◽  
Activity Program ◽  
Feasibility Testing

scholarly journals Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study (Preprint)

2020 ◽  
Author(s):  
Ryan A Mace ◽  
James D Doorley ◽  
Paula J Popok ◽  
Ana-Maria Vranceanu
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Cognitive Decline ◽  
Cognitive Functions ◽  
Self Report ◽  
Treatment Manual ◽  
Pain Clinic ◽  
Live Video ◽  
Activity Program ◽  
Body Activity

BACKGROUND Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. OBJECTIVE We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. METHODS This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). RESULTS The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). CONCLUSIONS Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/25351

The Role of Mindfulness and Relaxation in Improved Sleep Quality Following a Mind–Body and Activity Program for Chronic Pain

Mindfulness ◽  
2021 ◽  
Author(s):  
James D. Doorley ◽  
Jonathan Greenberg ◽  
Matthew Stauder ◽  
Ana-Maria Vranceanu
Keyword(s):  
Chronic Pain ◽  
Sleep Quality ◽  
Activity Program

scholarly journals Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function

2021 ◽  
Vol Volume 14 ◽  
pp. 359-368
Author(s):  
Jonathan Greenberg ◽  
Ryan A Mace ◽  
Sarah M Bannon ◽  
Ronald J Kulich ◽  
Ana-Maria Vranceanu
Keyword(s):  
Chronic Pain ◽  
Physical Function ◽  
Activity Program ◽  
Body Activity ◽  
Patient Reported
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