Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Smoking Tobacco
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

Description

The investigators have employed an experimental therapeutic paradigm to develop knowledge and inform a mechanistic-based approach for personalized smoking cessation for affective-vulnerable smokers. AS (Target Identification). Anxiety sensitivity (AS) is a relatively stable individual difference fac...

The investigators have employed an experimental therapeutic paradigm to develop knowledge and inform a mechanistic-based approach for personalized smoking cessation for affective-vulnerable smokers. AS (Target Identification). Anxiety sensitivity (AS) is a relatively stable individual difference factor that predisposes individuals to the development of anxiety/depressive problems9 by amplifying negative mood states (e.g., anxiety)10,11. Importantly, AS is related to, yet distinct from negative affectivity, distress intolerance, and experiential avoidance12, 13. To illustrate, when a person with high AS experiences physiological sensations (e.g., due to smoking abstinence), she/he is likely to misinterpret the symptoms as signs of impending personal threat (e.g., "I'm going crazy") and experience them as emotionally toxic (e.g., "I can't stand this discomfort anymore") 9. Thus, AS is an 'amplifying factor,' enhancing the aversiveness and need to escape/avoid negative affective or somatic experiences9, 14. There is strong evidence of the AS model in terms of the latent structure and stability of the construct, including samples of smokers15-19. AS also is unique from, and demonstrates incremental validity to, trait anxiety20 and negative affect18; thus, AS is distinguishable from frequency of anxiety and negative mood symptoms21. That is, the predictive power of AS relies on the fact that it is not just negative affect/sensations that drives maladaptive or impulsive behavior, but the relative sensitivity of these experiences. Notably, high AS is observed in 20-33% of smokers27-29 (or, from 9,200,0000-15,000,000 smokers in the U.S. alone), and therefore, is highly significant from a public health perspective. AS-Mental Health Relation. AS is an optimal candidate for personalized medicine. First, research has found that AS levels are elevated among individuals with anxiety and related disorders compared to those without such disorders22. Second, longitudinal studies with healthy adults23, 24 and adolescents25 indicate elevated AS predicts the future occurrence of anxiety and depressive symptoms and emotional disorders26. Third, laboratory studies indicate that AS is a significant predictor of fear responses to bodily sensations and stressors more generally27-29; these effects are evident above and beyond the variance accounted for by trait anxiety30. Fourth, AS significantly relates to avoidance-based response styles for coping with aversive events31 and is reliably correlated with smoking and other substance use to reduce negative affect32, 33. Collectively, AS is a transdiagnostic vulnerability factor for negative affect symptoms/syndromes. Such information is relevant to the present proposal because theoretically-driven cognitive-behavioral therapies (CBT) that reduce AS have proven to be effective therapeutic tactics for the prevention and treatment of emotional disorders34-36. AS-Smoking Relation. AS is a prominent and unique individual difference factor that is relevant to better understanding smoking maintenance and relapse processes37,38. There are numerous interrelated, but distinct, lines of independently replicated studies that document the role of AS in a multitude of smoking maintenance and relapse processes14, 38. This work is unique because the effects of AS for smoking processes is not explained by severity of tobacco dependence, gender, trait-like tendencies to experience negative affect states, or other types of substance use problems (e.g., alcohol)38. For example, prior work has found that AS is related to negative affect reduction motives and expectancies, and to a lesser extent, addictive as well as habitual motives39-43. These subjective expectations and motives may be linked to actual smoking effects, as high AS smokers also report greater smoking-induced reductions in subjective anxiety after stressful laboratory situations44, 45 and more positive subjective benefits of smoking46, 47. More recent work suggests that AS is related to the tendency to smoke in an inflexible manner when one is confronted with interoceptive stress (e.g., bodily tension)48. Other work has shown that AS is associated with the tendency to perceive quitting as more difficult49, 50 and to expect periods of smoking deprivation to be personally threatening51, 52. In fact, AS is related to greater negative affect, craving, and nicotine withdrawal symptoms53, 54, shorter time to lapse/relapse, and lower overall abstinence; findings that have been found during aided (i.e., pharmacological and psychosocial treatment) and unaided quit attempts (i.e., self-guided quit attempt)55. The effects of AS on lapse/relapse behavior operate through negative affect states and craving/withdrawal. Other studies demonstrate that AS mediates the relation between emotional disorders and severity of smoking behavior56-58. Overall, AS is an explanatory mechanism in smoking maintenance and relapse, thereby representing a therapeutic target for personalized medicine in the context of smoking cessation. Tobacco Use among African Americans. African American smokers smoke fewer cigarettes per day7 and tend to begin smoking later in life compared to non-Hispanic Whites.24,25 Yet, African Americans evince greater levels of nicotine dependence26 and serum cotinine.26-28 Although smoking fewer cigarettes per day should theoretically be associated with greater quit success,29 African American smoking prevalence continues to exceed that of non-Hispanic Whites24 regardless of socioeconomic status.10 African Americans suffer disproportionately from tobacco-related disease and death and have a higher incidence and mortality rate from lung cancer compared to non-Hispanic Whites.30,31 This issue is alarming, as the current prevalence rate of smoking among African Americans is 14.6%,32 which reflects approximately 6,421,678 million persons. Notably, up to 90% of African American adult smokers use menthol cigarettes, compared to 26% of White smokers,33 and as few as 5% of African American smokers ever switch from menthol to non-menthol cigarettes.34 There are harmful effects of menthol in cigarette smoking, including increased absorption and potential for dependence.35 Further, menthol smokers experience more difficulty quitting36 and less cessation success,37 including among African American menthol smokers compared to non-menthol smokers.38 Interoceptive Stress and Smoking among African Americans. African Americans are a health disparity group for interoceptive problems, including somatic symptoms, anxiety, stress, and pain,39-44 and evince stronger relations between negative emotional states and somatic experiences compared to non-Hispanic Whites.45 African Americans diagnosed with anxiety disorders experience higher rates of hypertension, a condition for which African Americans are almost twice as likely to be diagnosed relative to European Americans.46 African Americans' increased awareness of the negative outcomes of physical illnesses may amplify somatic anxiety and interoceptive distress.47,48 Given that nicotine produces acute anxiolytic effects,49 smokers with interoceptive distress often cope with such distress by smoking.50 Smokers with greater interoceptive stress, including African Americans, who experience negative affect during a quit attempt may return to smoking, in part, to alleviate increased physical and cognitive-affective manifestations of the interoceptive stress experience.51 Among the most prominent, cross-cultural constructs related to interoceptive distress is anxiety sensitivity (AS). AS is a malleable, cognitive-affective factor reflecting the tendency to respond to interoceptive distress with anxiety.52,53 AS is related to, yet distinct from, negative affectivity and trait anxiety.54,55-59,60 AS has demonstrated racial/ethnic, gender, age, and time invariance.59,61-64 Malleability of AS (Target Engagement). Controlled trials have documented the efficacy of interventions targeting AS, and by extension, improved clinical outcomes resulting from modifying fears of arousal sensations associated with high AS59. Meta-analytic evidence suggests the pooled effect sizes are large for CBT in reducing AS34-36; and these effects are maintained over time34-36. Moreover, reduction in AS during CBT for anxiety psychopathology accounts for 31% of the variance in symptom reduction60. As a point of reference, trait anxiety accounts for only 1.5% of variance60. Changes in AS temporally precede and predict changes in anxiety disorder symptoms, even when controlling for other well-established mechanisms of change (e.g., self-efficacy61). The most robust evidence suggest AS is best reduced via interoceptive exposure (eliciting feared [internal] stimuli), which is evident in the emphasis on targeting the construct in recently developed transdiagnostic treatments for emotional disorders62,63. Targeting AS via interoceptive exposure and anxiety-related psychoeducation (in-person or mobile delivered formats) also can be an efficacious prevention strategy for affective symptoms compared to active control conditions (e.g., health information) among both nonclinical and high-risk individuals64-66. AS can be reduced via interoceptive exposure to improve substance use behavior67,68. Here, the investigators have found a reduction in AS prior to quit day decreases the severity of craving and withdrawal symptoms during the first week of a quit attempt and enhances odds of abstinence for high AS smokers69, 70. The investigators have developed a theoretically-driven treatment for smoking cessation interventions that incorporates AS reduction methods71-73. Research suggests these treatments for high AS smokers increase the odds of quit success, reduce the amount smoked per day, and decrease time to relapse compared to standard smoking cessation treatments (pooled effect sizes being 2-5 times that of standard treatments)37, 74-78. The investigators recently tested AS-reduction in a RCT that evaluated an aerobic exercise augmentation to standard group-based CBT for smoking cessation78. Exercise is a 'community friendly' tactic for delivering interoceptive exposure79-81 because it elicits sensations of physiological arousal, and thereby, reduces AS82. Results indicated that at each of the major end points (1 week to 6-month follow-up), point prevalence abstinence (PPA) and prolonged abstinence (PA) rates were significantly higher for EX than for CTRL among high AS smokers. Our AS reduction model for smoking has been independently replicated to reduce the severity of substance use disorders83. Moreover, AS reduction in smoking cessation treatment mediates improvements in anxiety and depression when compared to nicotine replacement therapy and CBT relapse prevention84. Next Steps in Treatment Development Enhancing Dissemination Potential. Portable, adaptable, and easy to implement mobile interventions, delivered via smartphone app, may offer a more cost-effective and less time-intensive approach, ensure high fidelity, and enable the rapid diffusion and widespread adoption of science-based interventions85. Mobile interventions also offer a dynamic and visually-engaging design, video and audio features, text messaging, access without internet connection, and the ability to track progress and receive feedback in 'real time'85, 86. Given these features, smartphone apps have high potential to boost user engagement, which is a consistently robust predictor of successful smoking cessation87-90. Notably, more than 77% of US adults currently own smartphones 91, and ownership is projected to reach 90% by 202092, 93. Smartphones are used by adults from all socioeconomic strata, including 64% of low income adults 91. Such data highlight smartphone apps as a novel and highly accessible platform to deliver personalized smoking cessation treatment. Promise of mHealth. Smartphone-based smoking cessation apps could have a significant position in helping current and future generations of smokers quit smoking. Approximately 779,000 individuals download smoking cessation apps onto personal smartphones each month worldwide86. Versatile, fully automated, and always available smartphone apps could offer highly tailored, intensive, and low-burden treatments at a fraction of the cost of traditional smoking cessation counseling; thereby, overcoming many of the barriers that have hampered use of traditional empirically-supported smoking cessation treatments94, 95. However, such apps have not been evaluated among affective-vulnerable smokers. Mechanisms of Action. A strategic next step is to better understand the mechanisms of such interventions. Indeed, mechanistic research will provide guidance on how to best optimize the intervention for affectively vulnerable smokers and guide smoking cessation research overall. In our integrative theoretical model, the investigators posit that AS exacerbates anxiety/depression, withdrawal/craving, and the desire to smoke to reduce aversive internal states (i.e., smoking-specific experiential avoidance).38 Accordingly, AS may be a primary mechanism in improvements in smoking cessation outcome for interventions that target this risk factor. Thus, the investigators hypothesize that the efficacy of the intervention on quit success will be mediated by: reductions in the primary mechanism (AS), and thereafter, secondary mechanisms (anxiety and depression symptoms, nicotine withdrawal/craving, and smoking-specific experiential avoidance).

Tracking Information

NCT #
NCT04838236
Collaborators
University of Oklahoma
Investigators
Not Provided