Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers.
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ABSTRACT:
SUBMITTER: Davis JM
PROVIDER: S-EPMC3847085 | biostudies-literature | 2013 Sep
REPOSITORIES: biostudies-literature
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Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers.
Davis James M JM Mills David M DM Stankevitz Kristin A KA Manley Alison R AR Majeskie Matthew R MR Smith Stevens S SS
BMC complementary and alternative medicine 20130903
<h4>Background</h4>We report results of a pilot study designed to test a novel smoking cessation intervention, Mindfulness Training for Smokers (MTS), in smokers age 18-29 years with regular episodes of binge drinking. Mindfulness is a cognitive skill of applying close moment-to-moment attention to experience with a mental posture of acceptance and non-reactivity. The MTS intervention consisted of six weekly classes that provided instruction on how to use mindfulness to manage known precursors o ...[more]
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Project description:BackgroundBinge Drinking (BD) has been associated with altered inhibitory control and augmented alcohol-cue reactivity. Memory inhibition (MI), the ability to voluntarily suppress unwanted thoughts/memories, may lead to forgetting of memories in several psychiatric conditions. However, despite its potential clinical implications, no study to date has explored the MI abilities in populations with substance misuse, such as binge drinkers (BDs).MethodThis study-registered in the NIH Clinical Trials Database (ClinicalTrials.gov identifier: NCT05237414)-aims firstly to examine the behavioral and electroencephalographic (EEG) correlates of MI among college BDs. For this purpose, 45 BDs and 45 age-matched non/low-drinkers (50% female) will be assessed by EEG while performing the Think/No-Think Alcohol task, a paradigm that evaluates alcohol-related MI. Additionally, this work aims to evaluate an alcohol-specific MI intervention protocol using cognitive training (CT) and transcranial direct current stimulation (tDCS) while its effects on behavioral and EEG outcomes are assessed. BDs will be randomly assigned to one MI training group: combined [CT and verum tDCS applied over the right dorsolateral prefrontal cortex (DLPFC)], cognitive (CT and sham tDCS), or control (sham CT and sham tDCS). Training will occur in three consecutive days, in three sessions. MI will be re-assessed in BDs through a post-training EEG assessment. Alcohol use and craving will be measured at the first EEG assessment, and both 10-days and 3-months post-training. In addition, behavioral and EEG data will be collected during the performance of an alcohol cue reactivity (ACR) task, which evaluates attentional bias toward alcoholic stimuli, before, and after the MI training sessions.DiscussionThis study protocol will provide the first behavioral and neurofunctional MI assessment in BDs. Along with poor MI abilities, BDs are expected to show alterations in event-related potentials and functional connectivity patterns associated with MI. Results should also demonstrate the effectiveness of the protocol, with BDs exhibiting an improved capacity to suppress alcohol-related memories after both combined and cognitive training, along with a reduction in alcohol use and craving in the short/medium-term. Collectively, these findings might have major implications for the understanding and treatment of alcohol misuse.Clinical trial registration[www.ClinicalTrials.gov], identifier [NCT05237414].
| S-EPMC9278062 | biostudies-literature
Project description:Smoking continues to take an enormous toll on society, and although most smokers would like to quit, most are unsuccessful using existing therapies. These findings call on researchers to develop and test therapies that provide higher rates of long-term smoking abstinence. We report results of a randomized controlled trial comparing a novel smoking cessation treatment using mindfulness training to a matched control based on the American Lung Association's Freedom From Smoking program. Data were collected on 175 low socioeconomic status smokers in 2011-2012 in a medium sized midwestern city. A significant difference was not found in the primary outcome; intent-to-treat biochemically confirmed 6-month smoking abstinence rates were mindfulness=25.0%, control=17.9% (p=0.35). Differences favoring the mindfulness condition were found on measures of urges and changes in mindfulness, perceived stress, and experiential avoidance. While no significant differences were found in quit rates, the mindfulness intervention resulted in positive outcomes.
| S-EPMC4121076 | biostudies-literature
Project description:BackgroundThis was a secondary analysis of a pilot randomized controlled trial (RCT) of mindfulness-based stress reduction (MBSR) among young adult (YA) survivors of cancer, which showed preliminary evidence for improving psychosocial outcomes. Secondary outcomes assessed were the feasibility of collecting biological data from YAs and preliminary effects of MBSR on markers of inflammation and cardiovascular function.MethodParticipants were randomized to 8-week MBSR or a waitlist control condition. Participants provided whole blood spot samples for analysis of C-reactive protein (CRP) and interleukin (IL)-6 as well as blood pressure data in-person at baseline and 16-week follow-up. Feasibility was assessed with rates of providing biological data. Linear mixed effects modeling was used to evaluate preliminary effects of MBSR on inflammatory markers and blood pressure over time.ResultsOf 126 total participants enrolled, 77% provided biological data at baseline (n = 48/67 MBSR, n = 49/59 control). At 16 weeks, 97% of the 76 retained participants provided follow-up biological data (n = 34/35 MBSR, n = 40/41 control). Relative to the control group, MBSR was associated with decreased systolic blood pressure (p = 0.042, effect sizes (ES) = 0.45) and decreased diastolic blood pressure (p = 0.017, ES = 0.64). There were no changes in CRP or IL-6.ConclusionThis was the first study to explore the feasibility of collecting biological data from YA survivors of cancer and assess preliminary effects of MBSR on inflammatory and cardiovascular markers in an RCT. Minimally invasive biological data collection methods were feasible. Results provide preliminary evidence for the role of MBSR in improving cardiovascular outcomes in this population, and results should be replicated.
| S-EPMC9296689 | biostudies-literature
Project description:BACKGROUND:While there is a substantial literature on the efficacy of brief motivational intervention (BMI) for college student drinkers, research has focused less on young adults who do not attend a 4-year college, despite their elevated risk for excessive alcohol use and associated harmful consequences. METHODS:This randomized controlled trial (NCT01546025) compared the efficacy of BMI to a time-matched attention control intervention (relaxation training [REL]) for reducing alcohol consumption and related negative consequences in an underage young adult sample. BMI was tailored to the developmental transition out of high school for young adults who were not immediately planning to enroll in a 4-year college. Non-treatment-seeking underage drinkers who reported past-month heavy drinking (N = 167; ages 17 to 20; 42% female; 59% non-Hispanic White) were randomly assigned to receive a single session of BMI or REL. Outcomes were evaluated 6 weeks and 3 months postintervention via in-person assessments. RESULTS:Generalized estimating equation models provided strong support for the efficacy of BMI for reducing harmful drinking in these young adults. Compared to REL, and after controlling for baseline covariates including gender, those who received BMI subsequently reported significantly fewer average drinks per week, percent drinking days, percent heavy drinking days, lower peak and typical estimated blood alcohol concentration on drinking days, and fewer adverse consequences of drinking (all ps < 0.05). These between-group effects did not weaken over the course of the 3-month follow-up period. CONCLUSIONS:These findings demonstrate an efficacious approach to tailoring BMI for non-college-attending young adults. Future research should replicate and extend these findings over a longer follow-up period.
| S-EPMC6084798 | biostudies-literature
Project description:BackgroundStress can negatively impact an individual's health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device.MethodData were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated.ResultsParticipant device-adherence as well as the company's collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device.ConclusionsOur findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness.Trial registrationNCT02837016 . Registered 19 July 2016.
| S-EPMC7988913 | biostudies-literature
Project description:Binge drinking refers to a pattern of alcohol intake that raises blood alcohol concentration to or above legal intoxication levels. It is common among young adults and is associated with health risks that scale up with alcohol intake. Acute intoxication depresses neural activity via complex signaling mechanisms by enhancing inhibition mediated by gamma-amino butyric acid (GABA), and by decreasing excitatory glutamatergic effects. Evidence primarily rooted in animal research indicates that the brain compensates for the acute depressant effects under the conditions of habitual heavy use. These neuroadaptive changes are reflected in neural hyperexcitability via downregulated inhibitory signaling, which becomes apparent as withdrawal symptoms. However, human evidence on the compensatory reduction in GABA signaling is scant. The neurochemical aspect of this mechanistic model was evaluated in the present study with proton magnetic resonance spectroscopy (1H-MRS) which is sensitive to GABA plus macromolecule signal (GABA + ). Furthermore, we examined sex differences in GABA + levels as a function of a recent history of binge drinking, given interactions between endogenous neurosteroids, GABA signaling, and alcohol. The study recruited young adult women and men (22.2 ± 2.8 years of age) who were classified as binge drinkers (BDs, N = 52) if they reported ≥ 5 binge episodes in the previous six months. Light drinkers (LDs, N = 49) reported drinking regularly, but not exceeding ≤ 2 binge episodes in the past six months. GABA-edited 1H-MR spectra were acquired from the occipital cortex at 3 T with the MEGA-PRESS sequence. GABA + signal was analyzed relative to water and total creatine (Cr) levels as a function of binge drinking history and sex. Controlling for within-voxel tissue composition, both GABA + indices showed decreased GABA + levels in BDs relative to LDs. The reduced GABA + concentration was associated with occasional high-intensity drinking in the BD group. This evidence is consistent with compensatory GABA downregulation that accompanies alcohol misuse, tipping the excitation/inhibition balance towards hyperexcitability. Analysis of the time course of GABA + neuroplasticity indicated that GABA + was lowest when measured one day after the last drinking occasion in BDs. While the BD vs LD differences were primarily driven by LD women, there was no interaction between Sex and a history of binge drinking. GABA + was higher in LD women compared to LD men. Aligned with the allostasis model, the mechanistic compensatory GABA downregulation observed in young emerging adults engaging in occasional binge drinking complements direct neural measures of hyperexcitability in BDs. Notably, these results suggest that neuroadaptation to alcohol is detectable at the levels of consumption that are within a normative range, and may contribute to adverse health outcomes.
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Project description:BackgroundInterventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs.ObjectiveThis randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program.MethodsParticipants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed.ResultsIn the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice.ConclusionsThe program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance.ClinicaltrialClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).
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Project description:Evidence-based treatments for binge eating disorder (BED), such as cognitive behavioral therapy (CBT) lead to successful outcomes only about half the time. Individuals with BED often have measurable deficits in executive function (EF) that may challenge adherence to or impact of cognitive behavioral intervention components. The aim of this study was to evaluate the impact of adding EF training to CBT by combining CBT with a compensatory cognitive training approach (EF-CBT). Participants were 32 adults with BED, overweight/obesity, and comorbid anxiety or depression who were randomly assigned to four months of group treatment in either standard CBT or EF-CBT. Outcomes were assessed at baseline, post-treatment, and at 2-month follow-up. Results showed that EF-CBT was feasible and acceptable, comparable to CBT. Both groups significantly decreased loss of control (LOC) days, clinical impairment, and depression at post-treatment and 2-month follow-up; though there were no differences between groups. Neither group significantly reduced anxiety or weight. Exploratory analyses found that participants with lower EF treated with EF-CBT were less likely to have LOC at post-treatment than those with lower EF treated with CBT. Higher self-monitoring rates during treatment were associated with lower LOC at post-treatment and participants with lower EF were more likely to self-monitor in the EF-CBT arm relative to the CBT arm. These findings suggest that EF-CBT is feasible, acceptable and efficacious, although larger scale research is needed. EF-CBT may be particularly suited for individuals with BED who have lower EF.
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Project description:Young adulthood is a critical transition period for the development of health behaviors. We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers.We conducted a three-group randomized trial comparing delivery of general lifestyle content (Tx1), personally tailored health information (Tx2), and personally tailored health information plus online video-based peer coaching (Tx3) as part of a 6-week online health program. Participants were asked to set weekly goals around eating breakfast, exercise, alcohol use, and cigarette smoking. Eligibility criteria included age (18-30 years) and smoking status (any cigarette use in the previous 30 days). The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment.Participant (n = 1698) characteristics were balanced across the groups (72% women, mean age 24, 26% nonwhite, 32% high school education or less, and 50% daily smokers). Considering intention to treat, 30-day smoking abstinence rates were statistically significantly higher in the intervention groups (Tx1 = 11%, Tx2 = 23%, Tx3 = 31%, P < .001). Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising. Overall, intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors (Tx1 = 19%, Tx2 = 39%, Tx3 = 41%, P < .001).This online avatar-hosted personal health makeover "show" increased smoking abstinence and induced positive changes in multiple related health behaviors. Addition of the online video-based peer coaching further improved behavioral outcomes.
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Project description:Electronic cigarette (EC) use is growing dramatically with use highest among young adults and current smokers. One of the most common reasons for using ECs is interest in quitting or reducing cigarettes per day (CPD); however there are few randomized controlled trials (RCT) on the effect of ECs on smoking abstinence and reduction.We conducted a two-arm; double-blind RCT. Subjects were randomized to receive 3-weeks of either disposable 4.5% nicotine EC (intervention) or placebo EC. The primary outcome was self-reported reduction of at least 50% in the number of CPDs smoked at week 3 (end of treatment) compared to baseline. Study subjects (n = 99) were young adult (21-35), current smokers (smoked ? 10 CPDs) living in NYC.Compared with baseline, a significant reduction in CPDs was observed at both study time periods (1 and 3 weeks) for intervention (P < .001) and placebo (P < .001) groups. Between-group analyses showed significantly fewer CPDs in the intervention group compared to the placebo group at week 3 (P = .03), but not at any other follow-up periods. The logistic regression analysis showed that using a greater number of ECs, treatment condition and higher baseline readiness to quit were significantly associated with achieving at least 50% reduction in CPDs at the end of treatment.A diverse young adult sample of current everyday smokers, who were not ready to quit, was able to reduce smoking with the help of ECs. Further study is needed to establish the role of both placebo and nicotine containing ECs in increasing both reduction and subsequent cessation.Despite the critical need for well-designed clinical trials on the effect of ECs on cessation and cigarette reduction, the majority of studies have been observational or noncomparative intervention designs. Only three RCTs studying ECs as a cessation or reduction intervention have been published, and none were conducted in the United States. The current study adds knowledge to current literature on the feasibility of using ECs to aid smoking reduction among young smokers in US urban populations.
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