Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial.

Importance: Methadone treatment (MT) fails to address the emotion dysregulation, pain, and reward processing deficits that often drive opioid use disorder (OUD). New interventions are needed to address these factors. Objective: To evaluate the efficacy of MT as usual (usual care) vs telehealth Mindfulness-Oriented Recovery Enhancement (MORE) plus usual care among people with an OUD and pain. Design, Setting, and Participants: This study was a randomized clinical trial conducted from August 2020 to June 2022. Participants receiving MT for OUD and experiencing chronic pain were recruited at 5 clinics in New Jersey. Interventions: In usual care, participants received MT, including medication and counseling. Participants receiving MORE plus usual care attended 8 weekly, 2-hour telehealth groups that provided training in mindfulness, reappraisal, and savoring in addition to usual care. Main Outcomes and Measure: Primary outcomes were return to drug use and MT dropout over 16 weeks. Secondary outcomes were days of drug use, methadone adherence, pain, depression, and anxiety. Analyses were based on an intention-to-treat approach. Results: A total of 154 participants (mean [SD] age, 48.5 [11.8] years; 88 female [57%]) were included in the study. Participants receiving MORE plus usual care had significantly less return to drug use (hazard ratio [HR], 0.58; 95% CI, 0.37-0.90; P = .02) and MT dropout (HR, 0.41; 95% CI, 0.18-0.96; P = .04) than those receiving usual care only after adjusting for a priori-specified covariates (eg, methadone dose and recent drug use, at baseline). A total of 44 participants (57.1%) in usual care and 39 participants (50.6%) in MORE plus usual care returned to drug use. A total of 17 participants (22.1%) in usual care and 10 participants (13.0%) in MORE plus usual care dropped out of MT. In zero-inflated models, participants receiving MORE plus usual care had significantly fewer days of any drug use (ratio of means = 0.58; 95% CI, 0.53-0.63; P < .001) than those receiving usual care only through 16 weeks. A significantly greater percentage of participants receiving MORE plus usual care maintained methadone adherence (64 of 67 [95.5%]) at the 16-week follow-up than those receiving usual care only (56 of 67 [83.6%]; χ2 = 4.49; P = .04). MORE reduced depression scores and ecological momentary assessments of pain through the 16-week follow-up to a significantly greater extent than usual care (group × time F2,272 = 3.13; P = .05 and group × time F16,13000 = 6.44; P < .001, respectively). Within the MORE plus usual care group, EMA pain ratings decreased from a mean (SD) of 5.79 (0.29) at baseline to 5.17 (0.30) at week 16; for usual care only, pain decreased from 5.19 (0.28) at baseline to 4.96 (0.29) at week 16. Within the MORE plus usual care group, mean (SD) depression scores were 22.52 (1.32) at baseline and 18.98 (1.38) at 16 weeks. In the usual care-only group, mean (SD) depression scores were 22.65 (1.25) at baseline and 20.03 (1.27) at 16 weeks. Although anxiety scores increased in the usual care-only group and decreased in the MORE group, this difference between groups did not reach significance (group × time unadjusted F2,272 = 2.10; P= .12; Cohen d = .44; adjusted F2,268 = 2.33; P = .09). Within the MORE plus usual care group, mean (SD) anxiety scores were 25.5 (1.60) at baseline and 23.45 (1.73) at 16 weeks. In the usual care-only group, mean (SD) anxiety scores were 23.27 (1.75) at baseline and 24.07 (1.73) at 16 weeks. Conclusions and Relevance: This randomized clinical trial demonstrated that telehealth MORE was a feasible adjunct to MT with significant effects on drug use, pain, depression, treatment retention, and adherence. Trial Registration: ClinicalTrials.gov Identifier: NCT04491968.

Attentional control may be modifiable with Mindfulness-Based Cognitive Therapy to Prevent Suicide.

OBJECTIVE: To test whether Mindfulness-Based Cognitive Therapy to Prevent Suicide (MBCT-S) is associated with improvement in attentional control, an objective marker of suicide attempt. METHOD: In the context of a randomized clinical trial targeting suicide risk in Veterans, computerized Stroop and emotion Stroop (E-Stroop) tasks were administered 3 times over 6-months follow-up to 135 high suicide risk Veterans. Seventy were randomized to receive MBCT-S in addition to enhanced treatment as usual (eTAU), and 65 were randomized to eTAU only. E-Stroop word types included positively- and negatively-valenced emotion, suicide, and combat-related words. Interference scores and mixed effects linear regression analyses were used. RESULTS: Veterans receiving MBCT-S showed a more favorable trajectory of attentional control over time, as indicated by performance on two E-Stroop tasks. Combat-stress interference scores improved over time among Veterans in MBCT-S. Interference processing time for negative affective words deteriorated over time among Veterans receiving eTAU only. CONCLUSIONS: MBCT-S may effectively target attentional control, and in particular reduce processing time during affective interference, in high suicide risk Veterans. Future studies to replicate these findings are warranted.

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial.

Objective: This study evaluated whether Mindfulness-Based Cognitive Therapy for Preventing Suicide Behavior (MBCT-S) effectively augmented treatment-as-usual enhanced for suicide prevention (eTAU).Methods: From December 2013 through March 2018, veterans (N = 140) at high risk for suicide were recruited mostly (88.6%) during a suicide-related inpatient admission and randomly assigned to either (1) eTAU augmented with MBCT-S or (2) eTAU only. MBCT-S began during inpatient treatment (2 individual sessions emphasizing safety planning) and continued post-discharge (8 group sessions emphasizing mindfulness skills and elaborated safety planning). Four follow-up evaluations occurred over 12 months, and primary outcomes were (1) time to suicide event and (2) number of suicide events. Secondary outcomes were time to and number of suicide attempts, proportion with acute psychiatric hospitalization, and change in suicide-related factors (eg, depression, hopelessness, suicidal ideation).Results: Relative to eTAU, MBCT-S did not significantly delay time to suicide event (hazard ratio = 0.86; 95% CI, 0.52-1.41; P = .54), but did reduce total number of suicide events (MBCT-S: 56 events; eTAU: 92 events; incident rate ratio = 0.59; 95% CI, 0.36-0.99; P < .05). There were no significant differences in time to or number of suicide attempts. In a post hoc analysis, however, MBCT-S significantly reduced the proportion of participants attempting suicide (P < .05). MBCT-S also reduced the proportion with a psychiatric hospitalization. No significant between-group differences emerged on any suicide-related factors.Conclusions: Adding MBCT-S to system-wide suicide prevention efforts produced mixed findings on the primary outcome (suicide events) and promising findings on other important outcomes (suicide attempts, psychiatric hospitalizations). MBCT-S should continue to be examined in future research.Trial Registration: ClinicalTrials.gov identifier: NCT01872338.

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being.

BACKGROUND: Chronic pain is highly prevalent among people in methadone maintenance treatment (MMT) for opioid use disorder and is known to be an important contributor to treatment discontinuation and opioid relapse. Mindfulness-Oriented Recovery Enhancement (MORE) is one of the few interventions developed and tested as an integrated treatment to simultaneously address both pain and illicit opioid use; however, this study is the first to evaluate MORE as an adjunct to MMT. METHODS: Randomized individuals in MMT (N = 30) received MORE plus methadone TAU (n = 15) or methadone TAU, only (n = 15). Participants in the MORE arm received their MMT, as usual, and attended eight, weekly, two-hour MORE groups at their MMT clinics. Participants in the TAU arm received their MMT, as usual, and group or individual counseling, as required by the clinic. TAU counseling consisted of relapse prevention, cognitive-behavioral therapy, and supportive treatment. TAU participants did not receive any mindfulness-based intervention. Participants completed assessments at baseline, post-treatment (i.e., 8-weeks post-baseline), and follow-up (i.e., 16-weeks post-baseline). RESULTS: Participants in MORE evidenced significantly fewer baseline adjusted days of illicit drug use and significantly lower levels of craving through 16-week follow-up compared to TAU. Also, Participants in MORE reported significantly lower levels of pain, physical and emotional limitations, depression, and anxiety through 16-week follow-up compared to TAU. Conversely, participants in MORE reported significantly higher levels of well-being, vitality, and social functioning through 16-week follow-up compared to TAU. CONCLUSION: MORE could be an effective adjunct to MMT, and larger trials are warranted.

Past-year opioid misuse and suicide attempt are positively associated in high suicide risk veterans who endorse past- year substance use.

The main purpose of this study was to test the relationship between past-year suicide attempt (SA) and past-year opioid misuse among Veterans at high risk of suicide who reported using at least one illicit substance or alcohol in the past year. Baseline data from 130 high suicide-risk Veterans (n = 39 past-year opioid misusers; n = 91 past-year users of other substances) who enrolled in a randomized controlled trial testing adjunctive Mindfulness-Based Cognitive Therapy to Prevent Suicidal Behavior were used. Information was collected on a semi-structured interview that included the Columbia-Suicide Severity Rating Scale to collect suicide attempt history. Past-year opioid misusers, compared to those who used at least one other illicit substance or alcohol in the past year, were more likely to have made a past-year SA. Past-year opioid misuse remained associated with past-year SA in multivariate analysis that included other known risk factors for SA. Our findings show a robust link between near-term SA and opioid misuse in Veterans.

Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial.

BACKGROUND: Methadone maintenance therapy (MMT) is an efficacious form of medication assisted treatment for opioid use disorder (OUD), yet many individuals on MMT relapse. Chronic pain and deficits in positive affective response to natural rewards may result in dysphoria that fuels opioid craving and promotes relapse. As such, behavioral therapies that ameliorate chronic pain and enhance positive affect may serve as useful adjuncts to MMT. This analysis of ecological momentary assessment (EMA) data from a Stage 1 randomized clinical trial examined effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid craving, pain, and positive affective state. METHODS: Participants with OUD and chronic pain (N = 30) were randomized to 8 weeks of MORE or treatment as usual (TAU). Across 8 weeks of treatment, participants completed up to 112 random EMA measures of craving, pain, and affect, as well as event-contingent craving ratings. Multilevel models examined the effects of MORE on craving, pain, and affect, as well as the association between positive affect and craving. RESULTS: EMA showed significantly greater improvements in craving, pain unpleasantness, stress, and positive affect for participants in MORE than for participants in TAU. Participants in MORE reported having nearly 1.3 times greater self-control over craving than those in TAU. Further, positive affect was associated with reduced craving, an association that was significantly stronger among participants in MORE than TAU. CONCLUSION: MORE may be a useful non-pharmacological adjunct among individuals with OUD and chronic pain in MMT.

Rationale and study design of a trial of mindfulness-based cognitive therapy for preventing suicidal behavior (MBCT-S) in military veterans.

BACKGROUND: Although suicide ranks 10th as a cause of death in the United States, and 1st among active military personnel, there are surprisingly few evidence-based therapies addressing suicidality, and development of new treatments is limited. This paper describes a clinical trial testing a novel therapy for reducing suicide risk in military veterans. The intervention, Mindfulness-Based Cognitive Therapy for Preventing Suicide Behavior (MBCT-S), is a 10-week group intervention adapted from an existing treatment for depression (Mindfulness-Based Cognitive Therapy - MBCT). MBCT-S incorporates the Safety Planning Intervention, which is currently implemented throughout the Veterans Health Administration (VHA) for veterans at high suicide risk. METHODS: MBCT-S is being tested in a VHA setting using an intention-to-treat, two-group randomized trial design in which 164 high suicide risk veterans are randomized to either VHA Treatment As Usual (TAU; n=82) or TAU+MBCT-S (n=82). Our primary outcome measure, suicide-related event, defined to include suicide preparatory behaviors, self-harm behavior with suicidal or indeterminate intent, suicide-related hospitalizations and Emergency Department (ED) visits, will be measured through five assessments administered by blinded assessors between baseline and 12months post-baseline. We will measure suicide attempts and suicide deaths as a secondary outcome, because of their anticipated low incidence during the study period. Secondary outcomes also include severity of suicidal ideation, hopelessness and depression. SIGNIFICANCE: This study has the potential to significantly enhance the quality and efficiency of VHA care for veterans at suicide risk and to substantially improve the quality of life for veterans and their families.

Reviewing Mindfulness-Based Interventions for Suicidal Behavior.

This article describes the rationale for using mindfulness-based interventions (MBIs) to prevent suicidal behavior in high suicide-risk individuals. A narrative review of studies testing the feasibility of MBIs with individuals at risk for suicidal behavior and the effectiveness of MBIs for reducing suicidality was conducted. Studies testing the effectiveness of MBIs for reducing deficits specific to suicide attempters among depressed individuals were also reviewed as were studies examining moderators of MBI treatment adherence and effectiveness to the extent that these might suggest possible limitations to using MBIs with high suicide-risk individuals. Findings from the handful of available studies support targeting suicidal ideation with MBI. Additional studies show deficits associated with suicide attempt, namely attentional dyscontrol, problem solving deficits, and abnormal stress response, are improved by MBI and thus strengthen the rationale for using MBIs with high suicide-risk individuals.