Abstract
Objectives:
To summarize the characteristics of home practice adherence in patients with chronic pain randomized to a 10-week group mind–body activity program with (GetActive-Fitbit) and without (GetActive) a digital monitoring device, and test the association between home practice adherence and improvement in physical and emotional treatment outcomes.
Methods:
Data were collected in a pilot randomized controlled trial (RCT) of the GetActive (n = 41) and GetActive-Fitbit (n = 41) programs. Participants submitted weekly home practice logs depicting their daily physical activity and practice of relaxation and gratitude skills. Participants completed assessments of physical (patient-reported, performance-based, and accelerometer-measured) and emotional function outcomes both before and after the programs. Participants in both programs were combined due to the identical session and home practice content.
Results:
Participants reported engaging in physical activity on average 30.62 days (SD = 20.28, 48.6% of intervention days), relaxation skill practice on average 29.87 days (SD = 21.16, 47.4% of intervention days), and gratitude practice on average 32.10 days (SD = 22.12, 51.0% of intervention days). The average duration of physical activity and relaxation skill practice were 44.40 min a day (SD = 59.44) and 11.15 min a day (SD = 12.00), respectively. The duration of physical activity was significantly associated with decrease depression symptoms (p = 0.049, η2 = 0.056). No other association was found between home practice and change in outcomes.
Conclusions:
Patients with chronic pain are generally able and willing to engage in home practice during a mind–body activity intervention. Emphasizing longer duration of physical activity practice may contribute to an improvement in depression. Future fully powered RCTs with rigorous assessment of home practice adherence and dose-response designs may further elucidate the role of home practice in improvements in treatment outcomes.
ClinicalTrials.gov identifier:
NCT03412916.
Introduction
Individuals with chronic pain report a reduction in physical and emotional functions. 1 –3 Treatment interventions, including cognitive behavioral therapy (CBT), acceptance, and mindfulness-based approaches, can improve physical and emotional function among individuals with chronic pain, 4 –6 though effects are limited in size and sustainability. 7 –10 Such interventions typically emphasize the importance of daily home practice of skills, based on the premise that such practice supports improvement in treatment outcomes. However, support for this premise is unclear based on existing evidence.
Research examining the association between the amount of home practice and clinical outcomes has shown inconsistent findings. 11 The number of studies that specifically report information on the home practice and treatment outcome correlation is limited. 12 In some mindfulness-based intervention trials, home practice engagement was associated with improvement in quality of life, psychological distress, and health-related outcomes. 11,13 –15 Another study examining mindfulness-based stress reduction reported a nonsignificant association between weekly minutes practiced and psychological distress. 12
Results from a meta-analysis of CBT interventions showed greater homework compliance associated with improvement in outcomes across the quantity and quality of homework. 16 However, other mind–body interventions that teach relaxation response-inducing techniques have reported a lack of association between home practice and clinical outcomes. 17,18
This inconsistent relationship is also found in mindfulness-based intervention trials for patients with chronic illnesses, including pain, with some trials finding meaningful associations between components of home practice (e.g., frequency 19 ) and psychological symptoms, well-being, and social functioning, 13,20 and others showing no association between home practice and outcomes such as physical functioning and fatigue. 20 –22
Across CBT interventions for chronic pain, greater physical activity and relaxation skill home practice (e.g., activity tracking, breathing exercises, progressive muscle relaxation) was associated with improvement in psychosocial but not physical functioning. 22 Thus, additional work is needed to clarify the role of home practice in promoting positive treatment outcomes across patient populations.
Our team developed two novel and identical mind–body activity programs aimed at improving physical and emotional function among patients with chronic pain, one with the addition of a fitbit device (GetActive-Fitbit) and one without (GetActive). 23 The programs teach relaxation and mindfulness skills (e.g., deep breathing, mindfulness), pain-specific cognitive-behavioral skills (e.g., behavioral activation, adaptive thinking to reduce catastrophizing and avoidance, goal setting), and physical restoration skills (e.g., gradually increasing activity based on a set quota regardless of pain).
The programs include daily home practice in which participants log (1) physical activity between sessions, (2) engagement in relaxation and meditation practice, and (3) practice of gratitude. We previously demonstrated that the two programs were highly feasible and showed promise in improving physical and emotional function. 23,24
Although interventions such as GetActive and GetActive-Fitbit show potential for enhancing the functional ability of those with chronic pain, the role of home practice in influencing treatment outcomes has yet to be identified. Here, we conduct secondary data analysis to (1) summarize characteristics of home practice adherence among patients with chronic pain participating in the GetActive and GetActive-Fitbit programs; and (2) examine the relationship between home practice adherence and improvement in physical (patient-reported, performance-based, and accelerometer-measured) and emotional function.
We examined home practice components, including physical activity, relaxation and mindfulness skill practice, and practice of gratitude. We hypothesized that adherence to home practice will be associated with an improvement in physical and emotional clinical outcomes.
Methods
Participants
We recruited patients with heterogeneous musculoskeletal chronic pain through referrals from the hospital pain clinic, IRB-approved flyers, and hospital e-mail lists advertising the intervention. Inclusion criteria were: (1) age 18 years or older, (2) self-reported nonmalignant chronic pain more than 3 months, (3) ability to walk unassisted for at least 6 min, (4) accessibility to a mobile device with Bluetooth Version 4.0, (5) no changes in psychotropic and/or pain medications in the past 3 months, and (6) physician clearance.
Individuals were excluded if they met one or more of the following criteria: (1) expected worsening of medical illness in the next 6 months, (2) severe, untreated psychopathology or active suicidality, (3) active and untreated substance use disorder, (4) meditation, yoga, or relaxation skill practice for more than 45 min weekly in the past 6 months, (5) Fitbit device usage in the past 6 months, and (6) regular physical activity more than 30 min daily. A total of 82 participants were randomized to GetActive and GetActive-Fitbit. More information about the sample and feasibility benchmarks is detailed in the parent study. 24
Study design
We conducted secondary analyses of data from a pilot randomized controlled trial (RCT) of two mind-body activity programs with (GetActive-Fitbit) and without (GetActive), a digital monitoring device, 23,25 to assess the feasibility of use of a Fitbit device to track participant step-count. The trial was approved by the Institutional Review Board of the Massachusetts General Hospital. Participants were randomized to either the GetActive or GetActive-Fitbit intervention. Participants who were eligible and wished to participate provided informed consent.
Participants met for weekly 90-min sessions over a 10-week period where they were taught relaxation (e.g., deep breathing, guided imagery) and mindfulness (e.g., mindfulness of breath, body scan, mindfulness of pain) skills and cognitive-behavioral skills such as cognitive restructuring of pain-related thoughts and SMART goal-setting (defining goals according to specific, measurable, achievable, relevant, and time-based components). 25,26
Participants learned physical restoration skills such as quota-based pacing, which involves gradually increasing prescribed physical activity based on participants' amount of activity the previous week. Further details about program content are available. 23,25 Sessions began with reviewing participant home practice and physical activity goals and problem-solving barriers to adherence. Participants were instructed to engage in between-session home practice, including SMART goal-directed physical activity, 5–10 min of daily relaxation and mindfulness skill practice, and documenting at least 1 gratitude daily. Participants were encouraged to increase activity goals each week. Recordings of relaxation exercises were provided on the study's website.
Measures
Physical function
Informed by recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) 27,28 and International Classification of Functioning, Disability and Health (ICF) guidelines, 29 we assessed physical function through a combination of patient-reported, performance-based, and accelerometer-measured assessments.
Objective physical function
We used wGT3X-BT ActiGraph accelerometer devices 30 to track the average number of daily steps that participants took during the week before their first session and the week after their final session. Participants were instructed to wear the device daily during waking hours 1 week before and after the program. Study staff monitored the consistency between device-recorded wear time and self-reported wear time to ensure accuracy.
Performance-based physical function
We used the 6-min walk test 31 to capture the distance (meters) that participants walked in 6 min on a flat surface.
Self-reported physical function
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 was used to assess various aspects of physical functioning. This 36-item measure captures functioning in six areas: cognition, mobility, self-care, interactions with others, life activities, and participation. 32 We also used the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, version 1.2.8b to assess physical task performance ability across 8 items. 33 We included both measures to compare their respective sensitivity as part of feasibility testing and preparation for a future efficacy RCT. 23,24
Emotional function
Emotional function was measured by using two patient-reported assessments.
Self-reported emotional function
The PROMIS anxiety scale, 34 version 1.08a, is an 8-item measure assessing the frequency of anxiety symptoms in the past 7 days on a 5-point Likert scale. The 8-item PROMIS depression scale, 35 version 1.08b, measures the frequency of depression symptoms in the past week on a 5-point Likert scale. Both scales demonstrate excellent internal reliability (Cronbach's α = 0.95–0.96).
Home practice
Engagement in physical activity, relaxation and mindfulness skills, and gratitude were measured through practice logs in which participants recorded their daily home practice.
Physical activity home practice
We assessed physical activity practice frequency and duration. We calculated practice frequency by the average number of days each week that participants reported engaging in activity across all 10 weeks of the intervention. We calculated practice duration by averaging the reported amount of time spent engaging in physical activity each week. The intervention conceptualized activity tasks of daily living that required participants to stand or move about, and not “exercising” per se.
Relaxation and mindfulness skill home practice
The amount of relaxation-eliciting and mindfulness skill practice was assessed with two variables: (1) Frequency—The average number of days per week that participants reported practicing relaxation and mindfulness skills. The number of days participants reported practicing relaxation and mindfulness skills were summed across each week of the intervention, and the average number of days that participants reported relaxation and mindfulness skill practice was calculated for each week. (2) Duration—The average amount of time spent practicing relaxation and mindfulness skills per week. The number of minutes that participants reported practicing relaxation and mindfulness skills were summed across each week of the intervention, and the average time that participants spent engaging in relaxation and mindfulness skills was calculated for each week.
Gratitude skill home practice
The amount of gratitude skill home practice was assessed with two variables: (1) Frequency—Average number of days that gratitude was practiced per week, and (2) Number of gratitudes logged—Total number of gratitude reported throughout the program.
Data collection
Detailed information about data collection is available in the parent paper. 24 Participants completed measures 1 week before their first session and a week after their final session. Home practice logs were distributed at the start of the study, and participants returned logs of their daily home practice each week. As participants were instructed to record all daily practice, unreturned logs were considered indicative of no home practice and were recorded as such.
Information missing from logs was recorded as 0 to indicate no home practice. Daily logs that did not include a specific and quantifiable duration of time spent engaging in home practice (5.86% of logs) were excluded from duration analyses but were included in frequency analyses.
Statistical analysis
We used descriptive statistics to characterize home practice adherence across physical activity, relaxation and mindfulness, and gratitude skill home practice. Home practice components were examined across practice frequency, duration, and the number of gratitudes logged was also assessed. As GetActive-Fitbit and GetActive groups were identical across session content and prescribed home practice, participants were combined for the current analyses.
Between-group analyses revealed no statistically significant differences between the group conditions. Analyses were conducted by using IBM SPSS Statistics for Windows, Version 26. We conducted multiple regression analyses to examine the association between home practice components and physical and emotional function outcomes at the post-intervention time point. The model involved one outcome variable regressed on one home practice variable with the baseline value of the outcome entered as a covariate, which was conducted across each home practice variable and outcome variable.
Effect size is represented by the change in R 2 and is provided for all associations. The magnitude of the effect was determined based on statistical guidelines, which indicate the value associated with a small (0.02–0.13), moderate (0.13–0.26), and substantial effect size (>0.26). 36
Results
Participants
Participant demographic information is outlined in Table 1. The majority of participants were female (65.85%), and about half of the participants completed a form of higher education including a 4-year college degree (20.73%) or graduate or professional degree (34.15%). Participants ranged in age from 21 to 79 years, and the average age of participants was 51.8 years (SD = 14.4). All participants reported experiencing nonmalignant chronic pain for more than 3 months.
Demographic Characteristics of Participants
N = 82 for entire sample.
GED, General Educational Development.
Home practice descriptive characteristics
Participants reported engaging in physical activity an average of 30.62 days (SD = 20.28) out of the 63-day intervention period, or 48.61% of the intervention, and for an average of 44.40 min per week (SD = 59.44). Participants engaged in relaxation and mindfulness skill practice on an average of 29.87 days (SD = 21.16) during the treatment period (47.41%), for an average of 11.15 min per week (SD = 12.00). Across the 63-day intervention period, participants practiced gratitude skills on an average of 32.10 days (SD = 22.12), or 50.95% of the time, and documented an average of 52.38 (SD = 46.44) gratitudes.
Association between home practice and physical and emotional function outcomes
Multiple regression results demonstrated the relationship between home practice characteristics and physical and emotional function outcomes after accounting for the baseline physical and emotional function levels. See Table 2 for baseline and post-test outcome variable descriptive data. Physical activity home practice and self-reported physical function (PROMIS physical function) were not significantly correlated across practice frequency, ΔR 2 = 0.005, F(1, 68) = 0.722, p = 0.398, or duration, ΔR 2 = 0.009, F(1, 68) = 1.220, p = 0.273.
Physical and Emotional Function Outcome Variables Descriptive Summary
PROMIS, patient-reported outcomes measurement information system; WHODAS, World Health Organization Disability Assessment Schedule.
Physical activity frequency and duration were also not significantly associated with changes in WHODAS scores, step count, or the 6-min walk test. Results can be found in Table 3. Physical activity practice frequency was not significantly associated with components of emotional function, including depression, ΔR 2 = 0.002, F(1, 68) = 0.222, p = 0.639, and anxiety, ΔR 2 = 0.013, F(1, 68) = 1.324, p = 0.254. However, the duration of physical activity was significantly correlated with depression, ΔR 2 = 0.028, F(1, 68) = 4.021, p = 0.049 (a small effect size), such that a 1 min increase in the average duration of physical activity was associated with a decrease in 0.02 standard deviation of self-reported depression when controlling for baseline depression levels.
Regressions of Association Between Components of Home Practice and Physical and Emotional Function Outcomes
PROMIS, patient-reported outcomes measurement information system; WHODAS, World Health Organization Disability Assessment Schedule.
Although not statistically significant, the relationship between duration of physical activity and anxiety trended toward significance, ΔR 2 = 0.035, F(1, 68) = 3.731, p = 0.058 (a small effect size), showing that a 1 min increase in the average duration of physical activity was associated with a 0.18 decrease in the standard deviation of anxiety when controlling for baseline anxiety levels.
No significant associations emerged across relaxation skill practice variables and treatment outcomes. Neither gratitude practice frequency nor number of gratitudes correlated significantly with physical or emotional function. The results are detailed in Table 3.
Discussion
Although nonpharmacological interventions for chronic pain typically emphasize the importance of daily home practice of skills, the role of home practice in promoting positive treatment outcomes remains unclear. Here, we summarized the characteristics of home practice adherence among patients with chronic pain participating in two mind–body interventions and examined the relationship between home practice adherence and improvement in physical and emotional function.
Findings indicated that participants engaged in physical activity, relaxation and mindfulness skills, and gratitude home practice on approximately half the days throughout the 63-day treatment period. The frequency of engaging was similar (∼47% to ∼51% of practice days) across domains, which demonstrates that patients with chronic pain are able and willing to engage in physical activity, relaxation and mindfulness skills, and gratitude practice between sessions when participating in a 10-week mind–body activity program. This is encouraging given previous reports of low levels of adherence 37 and activity 38 in this population, as well as findings emphasizing that pain is often perceived to be a significant barrier to engaging in activity and other program components. 23,39
In examining the relationship between home practice adherence and primary treatment outcomes, the duration of physical activity home practice was significantly associated with a change in depression from baseline to post-intervention, so that the longer participants reported being active between sessions, the greater reduction in depressive symptoms they reported.
There was also a similar trend for anxiety. The fact that time spent engaging in physical activity was the only home practice component that was significantly associated with a treatment outcome suggests that the duration of physical activity, rather than frequency, may contribute to greater improvement in emotional outcomes from pre- to post-intervention. This is also consistent with literature emphasizing the connection between physical activity and overall mood and emotional affect. 40
The broader examination of home practice components related to outcomes showed no significant association between participant adherence and improvement. It is possible that the direction of the relationship between home practice and outcomes is reversed, such that participants may have experienced improvement in treatment outcomes, which contributed to increases in home practice. However, inferences about causality are beyond the scope of the current observational study.
Limitations
Some limitations of this study are worth considering. First, since we did not manipulate home practice, the causal effect of practice on outcomes cannot be established. It is possible that a change in outcomes altered motivation to practice at home, leading to increases or decreases in practice. Second, the relatively low duration of mindfulness and relaxation practice may have reduced the variance and statistical power needed to observe a significant effect. This finding, which is lower than practice times reported in other mind–body interventions, 17 highlights the need for better strategies to engage these patients. Emphasizing the importance of home practice and providing regular check-ins between sessions are strategies to support increasing duration of practice among participants. 41
Third, we adopted a conservative approach in coding missing data as lack of home practice, although it is possible that participants engaged in home practice but did not report it. Future research may use alternative methods of collecting home practice data such as logging practice via a mobile device to minimize missing data.
Fourth, despite the differences between relaxation and mindfulness skills, 42,43 these practices were grouped together as mind–body skills in the current intervention, which may have limited the ability to identify the distinct impact of each on treatment outcomes. Fifth, the self-reported nature of home practice may have played a role in the lack of association, as self-reported practice time can be subject to bias. This represents an important area for future research to explore the objective methods of assessing home practice.
Sixth, the relatively small sample size may have resulted in limited statistical power to detect associations between home practice and outcomes. Finally, the sample's homogeneity with regards to race limits the generalizability of findings and future studies should aim at recruiting more heterogeneous samples to determine whether results differ.
Conclusion
Patients with chronic pain are able and willing to engage in home practice of gratitude, relaxation and mindfulness skills, and physical activity in a mind–body and activity program. Increased duration of physical activity sessions may contribute to improvements in depressive symptoms. Future research with larger samples, objective assessments, and randomized clinical trial designs may deepen our understanding of the specific role played by adherence to home practice and physical and emotional outcomes in this population.
Footnotes
Authors' Contributions
S.W.H. managed data cleaning, ran data analyses, interpreted data, and wrote the article. J.G. assisted with statistical analysis, article preparation and provided expertise on all stages of the study. J.I. assisted with data quality assessment, data cleaning, and article preparation. A.-M.V. provided mentorship and expertise on all stages of the article writing process. All authors have read and approved the final version of the article and agree with the order of presentation of authors.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This study was funded by an R34 grant from the National Center for Complementary and Integrative Health to the senior author (1R34AT009356-01A1) and a K23 grant from the National Center for Complementary and Integrative Health to the second author (1K23AT01065301A1).
