Introduction
Chronic pain impairs physical and emotional function.1 Gains in physical and emotional function after cognitive-behavioral and mind–body interventions for chronic pain typically fade over time.2,3 Thus, there is a need for novel interventions to sustainably reduce pain and improve physical and emotional function among patients with chronic pain. Previously, we showed that two identical mind–body and activity programs, one with the addition of a Fitbit device (GetActive-Fitbit) and one without it (GetActive), improved pain, physical, and emotional function from baseline to postintervention.4 In this study, we examine whether these changes were sustained at a 3-month follow-up.
Methods
We randomized 82 participants with chronic pain to GetActive-Fitbit or GetActive (n = 41 each). Both interventions focused on mind–body skills (e.g., deep breathing and mindfulness), cognitive-behavioral skills adapted for chronic pain, and functional restoration skills. Participants completed self-report measures of physical function (World Health Organization Disability Assessment Schedule [WHODAS] 2.05; patient-reported outcomes measurement information system [PROMIS] physical function 1.2.8b6), depression (PROMIS depression scale v1.08b7), anxiety (PROMIS anxiety scale v1.08a8), and pain at rest and during activity (numerical rating scale), at baseline, postintervention, and 3-month follow-up. We tested both changes from baseline to the 3-month follow-up, and from postintervention to the 3-month follow-up, using linear mixed-models repeated measures Analyses of covariance for each outcome measure. Consistent with analysis recommendations for pilot studies,9 we limited our analyses to within-group changes for each group separately. We followed intent-to-treat guidelines to reduce bias and include all participants with valid data.
Results
Means and standard errors for all three time points are presented in Table 1. Changes across time are presented in Figure 1.
Table 1.
Unadjusted Means and Standard Errors at Baseline, Postintervention, and 3-Month Follow-up by Group
| Assessment | Baseline | Postintervention | Three-Month follow-up |
|---|---|---|---|
| Pain catastrophizing | |||
| GetActive | 19.71 (1.84) | 9.98 (1.29) | 9.91 (1.49) |
| GetActive-Fitbit | 22.27 (1.89) | 16.75 (1.77) | 16.79 (2.03) |
| Kinesiophobia | |||
| GetActive | 38.65 (1.32) | 31.42 (1.27) | 35.82 (1.46) |
| GetActive-Fitbit | 39.54 (1.38) | 35.22 (1.32) | 35.92 (1.45) |
| Pain resilience | |||
| GetActive | 37.68 (1.47) | 43.55 (1.64) | 45.02 (1.39) |
| GetActive-Fitbit | 32.51 (1.58) | 36.19 (1.82) | 36.13 (2.07) |
| Mindfulness | |||
| GetActive | 32.12 (0.99) | 36.09 (1.07) | 35.95 (1.09) |
| GetActive-Fitbit | 30.29 (1.11) | 33.07 (1.00) | 34.08 (1.36) |
| Adaptive coping | |||
| GetActive | 27.56 (1.49) | 36.09 (1.43) | 34.24 (1.50) |
| GetActive-Fitbit | 27.27 (1.50) | 34.10 (1.33) | 31.98 (1.36) |
FIG. 1.
Outcome measures (A) outcome measures for GetActive (B) outcome measures for GetActive-Fitbit.
Baseline to 3-month follow-up
Participation in both GetActive and GetActive-Fitbit was associated with sustained improvements from baseline to 3-month follow-up in WHODAS (GetActive: mean (M)difference = −6.03; 95% confidence interval [CI] = −0.62 to −11.44; p = 0.030; GetActive-Fitbit: Mdifference = −9.21; 95% CI = −15.78 to −2.65; p = 0.007), PROMIS physical function (GetActive: Mdifference = 4.960; 95% CI = 2.85 to 7.08; p < 0.001; GetActive-Fitbit: Mdifference = 4.01; 95% CI = 1.30 to 6.71; p = 0.005), pain at rest (GetActive: Mdifference = −0.89; 95% CI = −1.65 to −0.13; p = 0.023; GetActive-Fitbit: Mdifference = −1.40; 95% CI = −2.26 to −0.54; p = 002), and pain during activity (GetActive: Mdifference = 1.65; 95% CI = −2.37 to −0.92; p < 0.001; GetActive-Fitbit: Mdifference = −1.83; 95% CI = −2.76 to −0.91; p < 0.001). Differences in depression were near significant for GetActive (Mdifference = −2.93; 95% CI = −6.08 to −0.21; p = 0.066) and significant for GetActive-Fitbit (Mdifference = −4.28; 95% CI = −7.11 to −1.43; p = 0.004). Differences in anxiety were nonsignificant (GetActive: Mdifference = −2.01; 95% CI = −5.40 to 1.39; p = 0.237; GetActive-Fitbit: Mdifference = −2.06; 95% CI = −4.78 to −0.66; p = 0.133).
Postintervention to 3-month follow-up
There were no significant differences in either group between postintervention and 3-month follow-up in WHODAS (GetActive: Mdifference = 2.32; 95% CI: −3.00 to −7.63; p = 0.378; GetActive-Fitbit: Mdifference = −0.46; 95% CI: −4.28 to −3.36; p = 0.809), anxiety (GetActive: Mdifference = 2.30; 95% CI: −3.03 to −3.49; p = 0.886; GetActive-Fitbit: Mdifference = 0.89; 95% CI: −1.23 to −3.00; p = 0.400), depression (GetActive: Mdifference = −0.007; 95% CI: −1.98 to −1.97; p = 0.994; GetActive-Fitbit: Mdifference = 0.007; 95% CI: −2.33 to −2.34; p = 0.995), pain at rest (GetActive: Mdifference = 0.45; 95% CI: −0.35 to −1.26; p = 0.259; GetActive-Fitbit: Mdifference = −2.85; 95% CI: −1.05 to −0.48; p = 0.451), and pain during activity (GetActive: Mdifference = 0.125; 95% CI: −0.901 to −1.15; p = 0.804; GetActive-Fitbit: Mdifference = −0.69; 95% CI: −1.53 to −0.15; p = 0.102). For PROMIS physical function, GetActive continued to improve from postintervention to follow-up (Mdifference = 2.44; 95% CI: 0.38 to −4.49; p = 0.022), whereas GetActive-Fitbit did not change (Mdifference = 1.12; 95% CI: −0.76 to −3.00; p = 0.233).
Discussion
Compared with baseline level, improvements in physical function, depression, and pain intensity were sustained 3 months after completion of both programs. Anxiety levels remained numerically lower than at baseline, although these differences did not reach significance. Findings suggest that GetActive and GetActive-Fitbit show promise in sustainably improving physical function, depression, and pain intensity 3 months after program completion.
Limitations of this study include a modest sample size, lack of a control group, and relatively short follow-up period, consistent with the pilot nature of this study. Overall, these findings support conducting a fully powered clinical trial testing the efficacy and long-term effects of GetActive and GetActive-Fitbit against a psychoeducation control group. Combining mind–body and activity skills may be an effective and efficient method to sustainably improve outcomes among people with heterogeneous pain conditions.
Authors' Contributions
All authors contributed to the study conception and design. J.G. delivered the interventions, analyzed the data, and wrote the first draft of the article. A.-M.V. conceptualized the study and guided data interpretation and writing. P.J.P. assisted with materials, preparation, and data collection. R.J.K. provided input on data interpretation and article writing, and T.S. further assisted with materials and article preparation. All authors reviewed and approved the final article.
Ethical Approval
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the 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 (1R34AT009356-01A1) to the senior author and a K23 grant from the National Center for Complementary and Integrative Health (1K23AT010653-01A1) to the first author.
References
- 1. Arnow BA, Hunkeler EM, Blasey CM, et al. Comorbid depression, chronic pain, and disability in primary care. Psychosom Med 2006;68:262–268 [DOI] [PubMed] [Google Scholar]
- 2. Anheyer D, Haller H, Barth J, et al. Mindfulness-based stress reduction for treating low back pain: A systematic review and meta-analysis. Ann Intern Med 2017;166:799–807 [DOI] [PubMed] [Google Scholar]
- 3. Martorella G, Boitor M, Berube M, et al. Tailored web-based interventions for pain: Systematic review and meta-analysis. J Med Internet Res 2017;19:e385. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4. Greenberg J, Popok PJ, Lin A, et al. A mind-body physical activity program for chronic pain with or without a digital monitoring device: Proof-of-concept feasibility randomized controlled trial. JMIR Form Res 2020;4:e18703. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. World Health Organization. Measuring Health and Disability: Manual for Who Disability Assessment Schedule Whodas 2.0. Geneva, Switzerland: World Health Organization, 2010 [Google Scholar]
- 6. A brief guide to the PROMIS Physical Function instruments: Physical function. Published 2015. Online document at: www.healthmeasures.net/administrator/components/com_instruments/uploads/PROMIS Physical Function Scoring Manual.pdf, accessed July10, 2020
- 7. A brief guide to the PROMIS depression instruments. Patient Reported Outcomes Measurement Information System. Published 2015. Online document at: http://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Depression_Scoring_Manual.pdf, accessed July10, 2020
- 8. A brief guide to the PROMIS anxiety instruments. Outcomes Measurement Information System. Published 2015. Online document at: http://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Depression_Scoring_Manual.pdf, accessed July10, 2020
- 9. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res 2011;45:626–629 [DOI] [PMC free article] [PubMed] [Google Scholar]