NIH) redefined clinical trials to include any study involving behavioral or biomedical interventions. In line with a general framework from experimental medicine, we argue that it is crucial to distinguish between experimental laboratory studies aimed at revealing psychological mechanisms underlying behavior and randomized controlled trials (RCTs) in clinical samples aimed at testing the efficacy of an intervention. Method: As an illustration, we reviewed the current state of the evidence on the efficacy of cognitive bias modifi cation (CBM) interventions in alcohol use disorders. Results: A recent meta-analysis "cast serious doubts on the clinical utility of CBM interventions for addiction." That analysis combined experimental laboratory studies and RCTs. We demonstrated that, when studies are differentiated regarding study type (experimental laboratory study or RCT), mode of delivery (controlled experiment or Internet), and population (healthy volunteers or patients), the following effects are found: (a) short-lived effects of CBM on drinking behavior in experimental laboratory studies in students, but only when the bias is successfully manipulated; (b) small but robust effects of CBM on treatment outcome when administered as an adjunct to established treatments in clinical settings in RCTs with alcohol-dependent patients; and (c) nonspecific effects (reduced drinking irrespective of condition) in RCTs of CBM administered online to problem drinkers. Conclusions: We discuss how CBM might be improved when it is better integrated into regular treatment, especially cognitive behavioral therapy, and we conclude that disregarding the difference between experimental laboratory studies and RCTs can lead to invalid conclusions.
Cognitive Bias Modification (CBM) refers to a family of interventions targeting substance-related cognitive biases, which have been found to play a role in the maintenance of addictive behaviors. In this study, we conducted a Bayesian meta-analysis of individual patient data from studies investigating the effects of CBM as a behavior change intervention for the treatment of alcohol and tobacco use disorders, in individuals aware of the behavior change goal of the studies. Main outcomes included reduction in the targeted cognitive biases after the intervention and in substance use or relapse rate at the short-to-long term follow-up. Additional moderators, both at the study-level (type of addiction and CBM training) and at the participant-level (amount of completed training trials, severity of substance use), were progressively included in a series of hierarchical mixed-effects models. We included 14 studies involving 2435 participants. CBM appeared to have a small effect on cognitive bias (0.23, 95% credible interval = 0.06–0.41) and relapse rate (−0.27, 95% credible interval = −0.68 – 0.22), but not on reduction of substance use. Increased training practice showed a paradoxical moderation effect on relapse, with a relatively lower chance of relapse in the control condition with increased practice, compared to the training condition. All effects were associated with extremely wide 95% credible intervals, which indicate the absence of enough evidence in favor or against a reliable effect of CBM on cognitive bias and relapse rate in alcohol and tobacco use disorders. Besides the need for a larger body of evidence, research on the topic would benefit from a stronger adherence to the current methodological standards in randomized controlled trial design and the systematic investigation of shared protocols of CBM. Electronic supplementary material The online version of this article (10.1007/s11065-018-9386-4) contains supplementary material, which is available to authorized users.
Beyond the general appraisal of mental illness an individual might have, the results generally point to the acknowledgement of the specific features of different diagnostic categories. The implications of the present results are discussed in the framework of a better understanding of mental illness stigma.
BackgroundYoung adults often experiment with heavy use of alcohol, which poses severe health risks and increases the chance of developing addiction problems. In clinical patients, cognitive retraining of automatic appetitive processes, such as selective attention toward alcohol (known as “cognitive bias modification of attention,” or CBM-A), has been shown to be a promising add-on to treatment, helping to prevent relapse.ObjectiveTo prevent escalation of regular use into problematic use in youth, motivation appears to play a pivotal role. As CBM-A is often viewed as long and boring, this paper presents this training with the addition of serious game elements as a novel approach aimed at enhancing motivation to train.MethodsA total of 96 heavy drinking undergraduate students carried out a regular CBM-A training, a gamified version (called “Shots”), or a placebo training version over 4 training sessions. Measures of motivation to change their behavior, motivation to train, drinking behavior, and attentional bias for alcohol were included before and after training.ResultsAlcohol attentional bias was reduced after training only in the regular training condition. Self-reported drinking behavior was not affected, but motivation to train decreased in all conditions, suggesting that the motivational features of the Shots game were not enough to fully counteract the tiresome nature of the training. Moreover, some of the motivational aspects decreased slightly more in the game condition, which may indicate potential detrimental effects of disappointing gamification.ConclusionsGamification is not without its risks. When the motivational value of a training task with serious game elements is less than expected by the adolescent, effects detrimental to their motivation may occur. We therefore advise caution when using gamification, as well as underscore the importance of careful scientific evaluation.
Adding (social) game elements can increase motivation to train, and mobile training did not underperform compared with the regular training in this sample, which warrants more research into motivational elements for CBM training in younger audiences.
Background: Although scientific research on the etiology of mental disorders has improved the knowledge of biogenetic and psychosocial aspects related to the onset of mental illness, stigmatizing attitudes and behaviors are still very prevalent and pose a significant social problem.Aim: The aim of this study was to deepen the knowledge of how attitudes toward people with mental illness are affected by specific personal beliefs and characteristics, such as culture and religion of the perceiver. More precisely, the main purpose is the definition of a structure of variables, namely perceived dangerousness, social closeness, and avoidance of the ill person, together with the beliefs about the best treatment to be undertaken and the sick person’ gender, capable of describing the complexity of the stigma construct in particular as far as schizophrenia is concerned.Method: The study involved 305 university students, 183 from the University of Padua, Italy, and 122 from the University of Haifa, Israel. For the analyses, a latent class analysis (LCA) approach was chosen to identify a latent categorical structure accounting for the covariance between the observed variables. Such a latent structure was expected to be moderated by cultural background (Italy versus Israel) and religious beliefs, whereas causal beliefs, recommended treatment, dangerousness, social closeness, and public avoidance were the manifest variables, namely the observed indicators of the latent variable.Results: Two sets of results were obtained. First, the relevance of the manifest variables as indicators of the hypothesized latent variable was highlighted. Second, a two-latent-class categorical dimension represented by prejudicial attitudes, causal beliefs, and treatments concerning schizophrenia was found. Specifically, the differential effects of the two cultures and the religious beliefs on the latent structure and their relations highlighted the relevance of the observed variables as indicators of the expected latent variable.Conclusion: The present study contributes to the improvement of the understanding of how attitudes toward people with mental illness are affected by specific personal beliefs and characteristics of the perceiver. The definition of a structure of variables capable of describing the complexity of the stigma construct in particular as far as schizophrenia is concerned was achieved from a cross-cultural perspective.
BackgroundAddiction research has hypothesised that automatic and reflective cognitive processes play an important role in the onset and maintenance of alcohol (ab)use, wherein automatic reactions to drug-related cues steer the drug user towards consuming before reflective processes can get over and steer towards a different behavioural response. These automatic processes include the tendency to attend and approach alcohol cues. These biases may be trained away from alcohol via computerised cognitive bias modification (CBM). The present protocol describes the design of a double-blind randomised controlled trial (RCT) testing the effectiveness of attentional bias and approach bias re-training with a 2×2 factorial design, alongside a brief motivational support (MS) program.Methods/DesignParticipants (n = 120) are adult alcohol dependent outpatients, recruited from a public health service for addiction in Italy, who have been abstinent for at least two months, and with a main diagnosis of alcohol dependence disorder. Participants are randomly assigned to one of four experimental conditions and complete 11 sessions of training after a baseline assessment. The MS takes place before each training session. Post-intervention and three-month follow-up assessments examine the change in clinical outcome variables and attentional and approach biases (measured with the Visual Probe Task and the Approach-Avoidance Task, respectively). Alcohol approach-avoidance implicit memory associations (measured with the Brief Implicit Association Test) are also evaluated at pre- and post-intervention to explore generalisation effects. Primary outcome measure is relapse rate at follow-up. Secondary outcome measures include change in cognitive biases, in alcohol-related implicit memory associations, and in the clinical variables assessed. An exploratory analysis is also planned to detect interaction effects between the CBM modules and possible moderators (interference control capacity, gender, age, number of previous detoxifications) and mediators (change in cognitive bias) of the primary outcome measure.DiscussionThis RCT is the first to test the effectiveness of a combined CBM intervention alongside motivational support in alcohol-dependent outpatients. The results of this study can be extremely valuable for future research in the optimisation of CBM treatment for alcohol addiction.Trial registrationCurrent Controlled Trials ISRCTN01005959 (registration date: 24 October 2013).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0576-6) contains supplementary material, which is available to authorized users.
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