A large-scale randomized clinical trial found that telehealth-delivered mindfulness-based interventions may improve pain-related functioning and other outcomes among veterans with chronic pain compared with usual care.
In the study, published in JAMA Internal Medicine, researchers from the VA Health Systems Research Center and other institutions evaluated the effectiveness of group and self-paced mindfulness-based interventions (MBIs) in veterans with chronic pain over a 1-year period.
The researchers randomly assigned 811 veterans with moderate to severe chronic pain to one of three arms: group MBI (n = 270), self-paced MBI (n = 271), or usual care (n = 270). The primary outcome was pain-related function measured by the Brief Pain Inventory (BPI) interference scale at 10 weeks, 6 months, and 1 year.
The study population had a mean age of 54.6 years (standard deviation [SD] = 12.9) and included 387 women (47.7%). The racial and ethnic breakdown was: 66.1% White, 25.2% Black, 6.3% Hispanic, 1.2% American Indian/Alaska Native, 0.7% Asian American, and 0.1% Native Hawaiian/Pacific Islander. Nearly half (49.8%) had a bachelor's degree or higher, while only 30.6% reported a comfortable household financial situation.
Among the key findings were:
- Averaged across all follow-up time points, BPI interference scores were significantly lower for both MBI groups compared with usual care (group MBI vs control difference = –0.4, 95% confidence interval [CI] = –0.7 to –0.2; self-paced vs control difference = –0.7, 95% CI = –1.0 to –0.4).
- The probability of achieving 30% improvement from baseline in BPI interference scores was significantly greater for the group MBI at 10 weeks (33.6%) and 6 months (34.4%) compared with usual care (15.9% and 22.2%, respectively).
- The self-paced MBI showed significantly higher rates of 30% improvement at all time points, including 1 year (42.2% vs 24.1% for usual care).
- Both MBI arms had significantly better scores on secondary outcomes including pain intensity, physical function, anxiety, fatigue, sleep disturbance, social roles and activities, depression, and post-traumatic stress disorder.
- No significant differences were found between the group and self-paced MBI arms for most outcomes.
Pain diagnoses were diverse, with extremity pain/arthritis being most common (69.3%), followed by back pain (48%). Notably, 62.8% of the participants had at least one mental illness diagnosis in their electronic health record.
The 8-week group MBI consisted of 90-minute weekly videoconference sessions with 6 to 16 participants, while the self-paced MBI involved asynchronous weekly sessions supplemented by three facilitator phone calls. Both interventions utilized educational videos, workbooks, and a mobile application.
Adherence rates were 69% for the group MBI (≥ 6 of 9 sessions) and 76% for the self-paced MBI (≥ 2 of 3 facilitator calls). At 10 weeks, 78.6% of MBI participants reported weekly engagement in mindful mini practices, with 66.5% continuing at 12 months.
Secondary outcomes showed significant improvements in both MBI arms compared with usual care:
- Pain intensity (BPI pain intensity subscale): group MBI vs usual care difference = –0.4, 95% CI = –0.6 to –0.2, self-paced vs usual care difference = –0.4, 95% CI = –0.7 to –0.2
- Physical function (PROMIS): group MBI vs usual care difference = 0.5, 95% CI = 0.2 to 0.9, self-paced vs usual care difference = 0.6, 95% CI = 0.2 to 1.0
- Depression (PHQ-8): group MBI vs usual care difference = –0.9, 95% CI = –1.5 to –0.3, self-paced vs usual care difference = –0.9, 95% CI = –1.5 to –0.2
- PTSD (PCL-5): group MBI vs usual care difference = –2.0, 95% CI = –3.7 to –0.4, self-paced vs usual care difference = –2.2, 95% CI = –3.9 to –0.5.
No serious adverse events were reported. At 10 weeks, fewer participants in the MBI arms reported increased psychological or physical symptoms compared to usual care (27% group, 23% self-paced, and 53% usual care).
The study design was primarily pragmatic, with recruitment from real-world settings and broad inclusion criteria. This resulted in a sample with heterogeneous chronic pain conditions and high levels of psychiatric comorbidities.
Limitations included the inability to blind participants and facilitators, potential nonspecific effects of the interventions, and the fact that 81% of veterans contacted did not respond or declined participation. Additionally, the study did not address cost-effectiveness or compare these interventions to more intensive, in-person mindfulness programs.
Conflict of interest disclosures can be found in the study.