Interventions combining mindfulness training with non-invasive brain stimulation and their impact on mental health outcomes: Protocol for a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Mindfulness training programs and non-invasive brain stimulation are both evidence-based interventions that have applications in mental health disorders. While both have showed promising results on a range of symptoms related to mental health, their combination has more recently grabbed the attention of researchers. There is a theoretical framework for their synergistic effects, and these effects can be tested through a variety of neurophysiological and clinical outcomes. This emerging field of research, which is regularly extended with new trials, has not yet been systematically reviewed. This systematic review protocol aims to present a rationale for combining these two interventions and to document the methodical approach to our systematic review before data extraction. METHODS AND ANALYSIS: Four electronic databases (Medline, EMBASE, CENTRAL, PsycINFO) and three clinical trial registries (Clinical Trials, EU Trials, WHO ICTRP) were searched. All randomized controlled trials testing the combination of mindfulness-based interventions and non-invasive brain stimulation in humans will be included. As primary outcome, data on change in anxiety and depression symptoms from baseline, and, as secondary outcomes, other mental health outcomes data will be gathered. Data will be extracted independently by two authors using a predefined extraction form. Depending on the clinical heterogeneity of the included studies, the research team will decide whether a quantitative synthesis is appropriate for each of the predefined outcomes. If there is considerable statistical heterogeneity, subgroup analyses and meta-regression will be performed. Bias will be assessed using a revised Cochrane risk-of-bias tool for randomized trials and the strength of evidence in our review will be assessed using the GRADE form in GRADEPro. We started our scoping searches in November 2022. This systematic review and meta-analysis protocol was finished and submitted before the end of the independent full-text selection process by two members of the team. ETHICS AND DISSEMINATION: Ethics approval and consent to participate were not applicable to our systematic review. Our dissemination plan includes the publication of our systematic review and meta-analysis in an international peer-reviewed journal as well as international communication of our results. TRIAL REGISTRATION: PROSPERO registration number CRD42022353971.

Mindfulness interventions for craving reduction in substance use disorders and behavioral addictions: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: High-quality evidence is still required to affirm the efficacy of mindfulness-based interventions (MBIs) in craving reduction. MBIs may be particularly appropriate for this purpose given the neurobiological mechanisms of addiction with automatic behavior in response to the negative affect. In this systematic review and meta-analysis, we aimed to study the efficacy of MBIs in craving reduction and to synthetize the newly published data. METHODS: We searched four databases and three clinical trial registries for randomized controlled trials (RCTs) up to August 2023, including studies with MBIs in all types of substance use disorders or behavioral addictions. We chose as our outcome of interest the change from the baseline of craving measures at posttreatment. Standardized mean difference was used as an effect size estimator. RESULTS: We included 17 RCTs with 1228 participants. The overall effect size was estimated at -0.70 (95% CI -1.15, -0.26) in favor of MBIs. CONCLUSION: Due to the high inconsistency (I2 = 92%), we were unable to conclude that there is a medium to large effect size. Overall risk of bias was high for most studies, and the GRADE approach detected a low quality of evidence. Previous clinical and fundamental research suggest that MBIs have a promising potential in addiction medicine. However, further investigation of whether MBIs effectively reduce craving is needed, and innovative solutions for resolving methodological limitations in MBI research are warranted. TRIAL REGISTRATION: PROSPERO registration ID CRD42020221141.

Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial.

BACKGROUND: The number of people with an alcohol use disorder (AUD) was recently estimated to be 63.5 million worldwide. The global burden of disease and injury attributable to alcohol is considerable: about 3 million deaths, namely one in 20, were caused by alcohol in 2015. At the same time, AUD remains seriously undertreated. In this context, alternative or adjunctive therapies such as brain stimulation could play an important role. The early results of studies using repetitive transcranial magnetic stimulation (rTMS) suggest that stimulations delivered to the dorsolateral prefrontal cortex significantly reduce cravings and improve decision-making processes in various addictive disorders. We therefore hypothesize that rTMS could lead to a decrease in alcohol consumption in patients with AUD. METHODS/DESIGN: We report the protocol of a randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy of rTMS on alcohol reduction in individuals diagnosed with AUD. The study will be conducted in 2 centers in France. Altogether, 144 subjects older than 18 years and diagnosed with AUD will be randomized to receive 5 consecutive twice-daily sessions of either active or sham rTMS (10 Hz over the right DLPFC, 2000 pulses per day). The main outcomes of the study will be changes in alcohol consumption within the 4 weeks after the rTMS sessions. Secondary outcome measures will include changes in alcohol consumption within the 24 weeks, alcohol cravings, clinical and biological improvements, effects on mood and quality of life, and cognitive and safety assessments, and, for smokers, an assessment of the effects of rTMS on tobacco consumption. DISCUSSION: Several studies have observed a beneficial effect of rTMS on substance use disorders by reducing craving, impulsivity, and risk-taking behavior and suggest that rTMS may be a promising treatment in addiction. However, to date, no studies have included sufficiently large samples and sufficient follow-up to confirm this hypothesis. The results from this large randomized controlled trial will give a better overview of the therapeutic potential of rTMS in AUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04773691. Registered on 26 February 2021 https://clinicaltrials.gov/ct2/show/NCT04773691?term=trojak&draw=2&rank=5 .

Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 15 million persons in the European Union and 10 million persons in the USA are alcohol-dependent. The global burden of disease and injury attributable to alcohol is considerable: worldwide, approximately one in 25 deaths in 2004 was caused by alcohol. At the same time, alcohol use disorders remain seriously undertreated. In this context, alternative or adjunctive therapies such as brain stimulation may play a prominent role. The early results of studies using transcranial direct current stimulation found that stimulations delivered to the dorsolateral prefrontal cortex result in a significant reduction of craving and an improvement of the decision-making processes in various additive disorders. We, therefore, hypothesize that transcranial direct current stimulation can lead to a decrease in alcohol consumption in patients suffering from alcohol use disorders. METHODS/DESIGN: We report the protocol of a randomized, double-blind, placebo-controlled, parallel-group trial, to evaluate the efficacy of transcranial direct current stimulation on alcohol reduction in patients with an alcohol use disorder. The study will be conducted in 14 centers in France and Monaco. Altogether, 340 subjects over 18 years of age and diagnosed with an alcohol use disorder will be randomized to receive five consecutive twice-daily sessions of either active or placebo transcranial direct current stimulation. One session consists in delivering a current flow continuously (anode F4; cathode F3) twice for 13 minutes, with treatments separated by a rest interval of 20 min. Efficacy will be evaluated using the change from baseline (alcohol consumption during the 4 weeks before randomization) to 24 weeks in the total alcohol consumption and number of heavy drinking days. Secondary outcome measures will include alcohol craving, clinical and biological improvements, and the effects on mood and quality of life, as well as cognitive and safety assessments, and, for smokers, an assessment of the effects of transcranial direct current stimulation on tobacco consumption. DISCUSSION: Several studies have reported a beneficial effect of transcranial direct current stimulation on substance use disorders by reducing craving, impulsivity, and risk-taking behavior, and suggest that transcranial direct current stimulation may be a promising treatment in addiction. However, to date, no studies have included sufficiently large samples and sufficient follow-up to confirm the hypothesis. Results from this large randomized controlled trial will give a better overview of the therapeutic potential of transcranial direct current stimulation in alcohol use disorders. TRIAL REGISTRATION: Clinical Trials Gov, NCT02505126 (registration date: July 15 2015).

Massively multiplayer online role-playing games: comparing characteristics of addict vs non-addict online recruited gamers in a French adult population.

BACKGROUND: Massively Multiplayer Online Role-Playing Games (MMORPGs) are a very popular and enjoyable leisure activity, and there is a lack of international validated instruments to assess excessive gaming. With the growing number of gamers worldwide, adverse effects (isolation, hospitalizations, excessive use, etc.) are observed in a minority of gamers, which is a concern for society and for the scientific community. In the present study, we focused on screening gamers at potential risk of MMORPG addiction. METHODS: In this exploratory study, we focused on characteristics, online habits and problematic overuse in adult MMORPG gamers. In addition to socio-demographical data and gamer behavioral patterns, 3 different instruments for screening addiction were used in French MMORPG gamers recruited online over 10 consecutive months: the substance dependence criteria for the Diagnostic and Statistical Manual of Mental Disorder, fourth revised edition (DSM-IV-TR) that has been adapted for MMORPG (DAS), the qualitative Goldberg Internet Addiction Disorder scale (GIAD) and the quantitative Orman Internet Stress Scale (ISS). For all scales, a score above a specific threshold defined positivity. RESULTS: The 448 participating adult gamers were mainly young adult university graduates living alone in urban areas. Participants showed high rates of both Internet addiction (44.2% for GIAD, 32.6% for ISS) and DAS positivity (27.5%). Compared to the DAS negative group, DAS positive gamers reported significantly higher rates of tolerance phenomenon (increased amount of time in online gaming to obtain the desired effect) and declared significantly more social, financial (OR: 4.85), marital (OR: 4.61), family (OR: 4.69) and/or professional difficulties (OR: 4.42) since they started online gaming. Furthermore, these gamers self-reported significantly higher rates (3 times more) of irritability, daytime sleepiness, sleep deprivation due to play, low mood and emotional changes since online gaming onset. CONCLUSIONS: The DAS appeared to be a good first-line instrument to screen MMORPG addiction in online gamers. This study found high MMORPG addiction rates, and self-reported adverse symptoms in important aspects of life, including mood and sleep. This confirms the need to set up relevant prevention programs against online game overuse.