Heart Rate Variability-Informed Mobile Health (mHealth) Research to Promote Mindfulness Skills

 

Project Description:

The purpose of this project is to develop and pilot test a just-in-time adaptive intervention (JITAI) system to increase mindfulness practice engagement as a means of optimizing effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid dose reduction. The primary aim is to conduct a pilot randomized clinical trial (RCT) of MORE + JITAI (MORE+) to obtain effect sizes to power a future full-scale RCT.

 

Abstract:

The current opioid crisis in the U.S. emerged in large part from misuse of opioids by individuals with chronic pain. As many as 25% of patients prescribed long-term opioid therapy for chronic pain engage in opioid misusing behaviors such as unauthorized dose escalation or use of opioids to self-medicate negative emotions and stress that exacerbate craving. Chronic use of high dose opioids increases the risk for opioid misuse and escalation to full-blown opioid use disorder (OUD). At present, there are no evidence-based interventions to reduce opioid use among people receiving long-term opioid therapy for chronic pain. Conventional therapies may have limited efficacy without long-term maintenance because they fail to target self-regulatory mechanisms integral to restraining opioid dose escalation in the face of heighted pain, distress, and opioid craving. As such, new interventions that can enhance self-regulation are needed. To address this need, the PI developed a novel treatment for prescription opioid misuse, Mindfulness-Oriented Recovery Enhancement (MORE), which integrates mindfulness training, cognitive reappraisal, and amplification of natural reward processing to strengthen self-regulatory capacity and disrupt the cycle of pain, distress, and craving underpinning the downward spiral of opioid dose escalation leading to opioid misuse and OUD.

MORE has been shown to be efficacious in two Stage 2 RCTs. In the first of these trials, MORE significantly decreased opioid misuse and craving, as well as reduced chronic pain severity and functional impairment, relative to a support group (SG) control. In the second trial, MORE again significantly decreased opioid misuse and pain severity, and also reduced opioid dose relative to a SG control. The effects of MORE on reducing opioid dose were mediated by increases in heart rate variability (HRV) during mindfulness practice. Mindfulness practice time significantly predicted increases in HRV and decreases in opioid dosing, suggesting that mindfulness practice is crucial to obtaining positive outcomes from the MORE intervention. However, it is clear from these two trials that not all patients engage in mindfulness practice or respond to the MORE intervention. As such, the MORE intervention could be optimized by increasing mindfulness practice engagement. The just-in-time adaptive intervention (JITAI) approach may serve as a promising means of enhancing mindfulness practice engagement. In JITAI, smartphones are used to prompt participants to engage in therapeutic skill practice at the precise moment when such practice is needed – i.e., when they are distressed, or in the specific case of chronic pain patients at risk for opioid misuse, at the precise moment when they are experiencing elevations in pain or opioid craving. Pain, distress, and craving can be identified by self-reported ecological momentary assessments (EMA). However, ambulatory HRV can also index pain, distress, and craving; prior studies demonstrate that phasic decreases in HRV are associated with momentary pain, distress, and craving. Mobile health (mHealth) technology can deploy JITAI when triggered by EMA self-reports, and leading-edge technological advances now allow JITAI to be triggered by physiological signals, including HRV. In this seed grant, we propose to develop and pilot test a JITAI system to increase mindfulness practice engagement as a means of optimizing opioid dose outcomes from the MORE intervention. The primary aim of this proposal is to conduct a pilot RCT of MORE + JITAI (MORE+) to obtain effect sizes to power a future R01-funded, full scale RCT. This proposal is fully congruent with the goals of NIDA R01 PAR-19-212 to “encourage behavioral intervention development research to test efficacy, conduct clinical trials, [and] examine mechanisms of behavior change” for “interventions for patients with comorbidities… [and] chronic pain; drug abuse treatment and adherence interventions for use in primary care; [and] drug abuse treatment and adherence interventions that utilize technologies to boost effects.”

 

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