Mindfulness-Oriented Recovery Enhancement for Opioid Use during Pregnancy: A Pilot Randomized Controlled Trial

Background and Purpose: Over the past decade, there have been a growing number of women using opioids during pregnancy resulting in consequences for women, families, and society overall. Despite an increased need for behavioral treatment, there has been a lag in research focusing on behavioral interventions for pregnant women using opioids. Mindfulness-based approaches are demonstrating promise in treating opioid use disorder and misuse. The purpose of this pilot randomized controlled trial (RCT) was to evaluate the preliminary efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), with pregnant women using opioids.

Methods: Pregnant women (N = 51) were recruited from a high-risk prenatal clinic. To be included in the study, participants had to be pregnant, over the age of 18, fluent in English, and using or taking opioids. Participants were randomized to either eight weeks of MORE or a supportive psychotherapy control (SPT) condition. Pre- and post-intervention, participants met with study staff to complete self-report measures including the Depression Anxiety and Stress Scales (DASS) and an opioid visual analog scale (OVAS). Participants also completed self-report measures during each therapy session evaluating opioid craving and negative affect.

Results: Intention-to-treat analyses revealed MORE led to significant reductions in stress and anxiety compared to supportive psychotherapy. For anxiety, linear mixed models revealed a significant effect of treatment condition, F(1,44.10) = 4.64, p = .04, and treatment X time, F(1,26.27) = 4.97, p = .04. Similarly, for stress, there was a significant effect of treatment condition, F(1,27.59) = 4.19, p = .05, and treatment X time effect, (F(1,20.92) = 4.26, p = .05). These findings indicate MORE significantly decreased anxiety and stress to a greater extent than SPT. Latent growth curve analyses of session rating scales revealed a significant impact on negative affect (x² ₍₆₎ = 7.26, p = .30; CFI = 0.87; RMSEA = .48 (90% CI [.00, .15] and opioid craving (x² ₍₆₎ = 2.85, p = .30; CFI = 1.00; RMSEA = .00 (90% CI [.00, .08] after three MORE treatment sessions. Treatment condition significantly predicted the negative affect change factor (b = -1.32, p = 0.02), such that participants randomly assigned to MORE reported greater decreases in negative affect scores (42% decrease overall) over the first three treatment sessions when compared to participants assigned to SPT. Treatment condition significantly predicted the craving change factor (b = -0.59, p = 0.02), such that participants randomly assigned to MORE reported greater decreases (51% decrease overall) in opioid craving scores over the first three treatment sessions when compared to participants assigned to SPT

Conclusion and Implications: Findings indicate that participation in MORE may lead to decreases in anxiety, stress, and opioid craving among pregnant women taking opioids. The study was limited by a small sample size and a high rate of attrition. Despite these limitations, we conclude that further research is warranted to evaluate the effects of MORE with this group.