A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults.

Abstract

Low income and low educational attainment are among the strongest predictors of both smoking prevalence and lapse (i.e., return) to smoking after cessation attempts. Treatment refinement is limited by inadequate knowledge of the specific lapse- or relapse-relevant vulnerabilities characteristic of populations that should be the target of treatment. In the context of a randomized clinical trial design, we describe an experimental medicine approach for evaluating the role of 2 specific lapse-relevant targets relative to the higher stress characteristic of low-socioeconomic contexts: low distress tolerance and low working memory capacity. Furthermore, we use an innovative approach for understanding risk of smoking lapse in smokers undergoing a quit attempt to examine candidate mechanistic targets assessed not only during nicotine use, but also during the conditions smokers will face upon a cessation attempt—during stressful nicotine-deprivation windows. This study is designed to show the incremental value of assessments during deprivation windows, in part because of the way in which specific vulnerabilities are modified by, and interact with, the heightened stress and withdrawal symptoms inherent to nicotine-deprivation states. Specifically, the study is designed to evaluate whether a novel mindfulness intervention (mindfulness combined with interoceptive exposure) can improve upon existing mindfulness interventions and extend therapeutic gains to the modification of mechanistic targets assessed in high-stress or negative affectivity contexts. The overall goal is to validate mechanistic targets and associated interventions for the purpose of expanding treatment options for at-risk smokers.

Anxiety sensitivity as a malleable mechanistic target for prevention interventions: A meta-analysis of the efficacy of brief treatment interventions.

“…Further application of the SOBC experimental medicine approach to target AS is encouraged in health prevention and intervention studies (e.g. Otto et al, 2020; Smits et al, 2016, 2019; Zvolensky, Garey, et al, 2018; Zvolensky, Rosenfield, et al, 2018).…”

Using early phase studies to advance intervention research: The science of behavior change.

“…Otto and colleagues present a mechanistic randomized controlled trial protocol for engaging distress tolerance and working memory (two putative mechanisms of action) to improve smoking relapse rates in smokers from lower socioeconomic living circumstances (Otto et al, 2020). They test if the proposed mechanisms of action are improved during stressful nicotine-deprivation windows—when the mechanism would or would not aid in smoking cessation maintenance.…”

Toward an open mechanistic science of behavior change.

“…Beyond time, context also is often postulated as profoundly important. Although context mattered a great deal in many articles, Otto et al (2020) stated the importance succinctly when they wrote that “. .…”

“…The articles collectively display a diversity of thought on intervention operations, control condition selection, and measurement batteries of the theorized mechanisms of action under investigation. For example, Brewer et al (2020), Otto et al (2020), and Mackiewicz Seghete’s et al (2020) articles all advance mindfulness interventions but with different intervention operations and hypotheses postulated for each (in part as each is focused on distinct populations and different targeted mechanisms). In terms of control conditions, while many researchers chose a treatment-as-usual or similar clinical variant, others, such as Birk et al (2020), chose very tight mechanistic-oriented control conditions, with that research group going so far as to include a sham control condition for their theorized mechanism of cognitive bias modification.…”

“…The 10 articles in this commentary illustrate the considerable breadth and depth of thought involved in conducting a robust mechanistic science of behavior change (Birk et al, 2020; Brewer, Roy, Deluty, Liu, & Hoge, 2020; Dong et al, 2020; Halbert et al, 2020; Leahey et al, 2020; Mackiewicz Seghete et al, 2020; McHugh, Nguyen, Fitzmaurice, & Dillon, 2020; Otto et al, 2020; Scioli et al, 2020; Wilson et al, 2020). There are a wide range of different populations being supported (e.g., patients with acute coronary syndrome, parent/adolescent dyads, African American women breast cancer survivors, adults experiencing opioid use disorder), intervention strategies (e.g., mindfulness, delay discounting tasks, affect labeling, exercise), mechanisms (e.g., fear of recurrence, delay discounting, stress reactivity, neuropeptide Y, self-regulation), and behaviors/health outcomes (e.g., physical activity, sleep, worry, medication adherence).…”