Research into evidence-based psychological interventions needs a stronger focus on replicability

Background:It is a precondition for evidence-based practice that research is replicable in a wide variety of clinical settings. Current standards for identifying evidence-based psychological interventions and making recommendations for clinical practice in clinical guidelines include criteria that are relevant for replicability, but a better understanding as well refined definitions of replicability are needed enabling empirical research on this topic. Recent advances on this issue were made in the wider field of psychology and in other disciplines, which offers the opportunity to define and potentially increase replicability also in research on psychological interventions. Method: This article proposes a research strategy for assessing, understanding, and improving replicability in research on psychological interventions. Results/Conclusion: First, we establish a replication taxonomy ranging from direct to conceptual replication adapted to the field of research on clinical interventions, propose study characteristics that increase the trustworthiness of results, and define statistical criteria for successful replication with respect to the quantitative outcomes of the original and replication studies. Second, we propose how to establish such standards for future research, i.e., in order to design future replication studies for psychological interventions as well as to apply them when investigating which factors are causing the (non-)replicability of findings in the current literature

Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial

Background Although effective treatments for smoking cessation are available, long-term abstinence is the exception rather than the norm. Accordingly, there is a need for novel interventions that potentially improve clinical outcome. Although implicit information processing biases, for example approach biases for smoking-related stimuli, are ascribed a dominant role in the maintenance of tobacco dependence, these biases are hardly targeted in current treatment. Past research has shown that so-called Approach Bias Modification (AppBM) trainings, aiming to modify this bias, lead to improved long-term abstinence in abstinent alcoholic inpatients when delivered as an add-on to treatment-as-usual. Findings on the efficacy of AppBM in smoking have been inconsistent. The present large-scale clinical trial pursues two goals. First, it aims to investigate the efficacy of AppBM as an add-on to treatment-as-usual in a representative sample of adult smokers. Second, possible mechanisms of change are investigated. Methods The study is a randomized-controlled, double-blind, parallel-group superiority trial. We aim at a final sample of at least 336 adult smokers. Participants are allocated with a 1:1:1 allocation ratio to one of the following conditions: (1) treatment-as-usual + AppBM, (2) treatment-as-usual + Sham, (3) treatment-as-usual only. During the add-on training, participants are presented smoking-related and positive pictures and are instructed to respond by either pushing or pulling a joystick, depending on the tilt of the pictures (5 ○ to the left/right). During AppBM, all smoking-related pictures are tilted in the direction that is associated with pushing, thereby aiming to train an avoidance bias for smoking. All positive pictures are tilted in the direction associated with pulling. During Sham, the contingency is 50/50. Participants are assessed before and after the intervention and at a 6-month follow-up. The primary outcome is prolonged abstinence, and secondary outcomes include smoking-related variables and psychological distress. Additionally, the motivational significance of smoking-related stimuli (i.e., approach bias, valence) is assessed with different experimental tasks (Approach-Avoidance Task; Single Target Implicit Association Test) and psychophysiological measures. Discussion This is the first large-scale clinical trial investigating the efficacy of AppBM as an add-on in smokers including a TAU only condition. Additionally, it is the first study to systematically investigate potential mechanisms mediating the effects of treatment on clinical outcome

Predicting Impaired Extinction of Traumatic Memory and Elevated Startle

Emotionally traumatic experiences can lead to debilitating anxiety disorders, such as phobias and Post-Traumatic Stress Disorder (PTSD). Exposure to such experiences, however, is not sufficient to induce pathology, as only up to one quarter of people exposed to such events develop PTSD. These statistics, combined with findings that smaller hippocampal size prior to the trauma is associated with higher risk of developing PTSD, suggest that there are pre-disposing factors for such pathology. Because prospective studies in humans are limited and costly, investigating such pre-dispositions, and thus advancing understanding of the genesis of such pathologies, requires the use of animal models where predispositions are identified before the emotional trauma. Most existing animal models are retrospective: they classify subjects as those with or without a PTSD-like phenotype long after experiencing a traumatic event. Attempts to create prospective animal models have been largely unsuccessful.Here we report that individual predispositions to a PTSD-like phenotype, consisting of impaired rate and magnitude of extinction of an emotionally traumatic event coupled with long-lasting elevation of acoustic startle responses, can be revealed following exposure to a mild stressor, but before experiencing emotional trauma. We compare, in rats, the utility of several classification criteria and report that a combination of criteria based on acoustic startle responses and behavior in an anxiogenic environment is a reliable predictor of a PTSD-like phenotype.There are individual predispositions to developing impaired extinction and elevated acoustic startle that can be identified after exposure to a mildly stressful event, which by itself does not induce such a behavioral phenotype. The model presented here is a valuable tool for studying the etiology and pathophysiology of anxiety disorders and provides a platform for testing behavioral and pharmacological interventions that can reduce the probability of developing pathologic behaviors associated with such disorders

A randomised controlled trial of a brief online mindfulness-based intervention in a non-clinical population: replication and extension

Building on previous research, this study compared the effects of two brief, online mindfulness-based interventions (MBIs; with and without formal meditation practice) and a no intervention control group in a non-clinical sample. One hundred and fifty-five university staff and students were randomly allocated to a 2-week, self-guided, online MBI with or without mindfulness meditation practice, or a wait list control. Measures of mindfulness, perceived stress, perseverative thinking and anxiety/depression symptoms within were administered before and after the intervention period. Intention to treat analysis identified significant differences between groups on change over time for all measured outcomes. Participation in the MBIs was associated with significant improvements in all measured domains (all ps < 0.05), with effect sizes in the small to medium range (0.25 to 0.37, 95% CIs 0.11 to 0.56). No significant changes on these measures were found for the control group. Change in perseverative thinking was found to mediate the relationship between condition and improvement on perceived stress and anxiety/ depression symptom outcomes. Contrary to our hypotheses, no differences between the intervention conditions were found. Limitations of the study included reliance on self-report data, a relatively high attrition rate and absence of a longer-term follow-up. This study provides evidence in support of the feasibility and effectiveness of brief, self-guided MBIs in a non-clinical population and suggests that reduced perseverative thinking may be a mechanism of change. Our findings provide preliminary evidence for the effectiveness of a mindfulness psychoeducation condition, without an invitation to formal mindfulness meditation practice. Further research is needed to confirm and better understand these results and to test the potential of such interventions

Children’s Postdisaster Trajectories of PTS Symptoms: Predicting Chronic Distress

BACKGROUND: There are no studies of the distinct trajectories of children’s psychological distress over the first year after a destructive natural disaster and the determinants of these trajectories. OBJECTIVE: We examined these issues using an existing dataset of children exposed to Hurricane Andrew, one of the most devastating natural disasters in US history. METHODS: At 3-months postdisaster, 568 children (55 % girls; grades 3–5) residing in areas most directly affected by the hurricane completed measures of hurricane exposure and stressors, social support, coping, and general anxiety. Children also reported major life events occurring since the hurricane (at 7-months) and posttraumatic stress (PTS) symptoms at 3-, 7-, and 10-months postdisaster. RESULTS: Latent growth mixture modeling identified three trajectories of PTS reactions: resilient (37 %), recovering (43 %), and chronic distress (20 %). Predictors of the trajectories were examined. Odds ratios indicated that, compared to the resilient trajectory, girls were more likely to be in the recovering and chronically distressed trajectories, as were children reporting higher anxiety and greater use of coping strategies that reflected poor emotion regulation. Compared to the recovering trajectory, children in the chronically distressed trajectory had greater odds of reporting high anxiety, less social support, more intervening life events, and greater use of poor emotion regulation strategies. CONCLUSIONS: Hurricane exposure may be less effective in identifying children who develop chronic postdisaster distress than other child (anxiety, coping) and contextual variables (social support, life events). Effective screening after disasters is critical for identifying youth most in need of limited clinical resources

The Role of Rumination and Reduced Concreteness in the Maintenance of Posttraumatic Stress Disorder and Depression Following Trauma

Rumination has been linked to posttraumatic stress disorder (PTSD) and depression following trauma. A cross-sectional (N = 101) and a prospective longitudinal study (N = 147) of road traffic accident survivors assessed rumination, PTSD and depression with self-report measures and structured interviews. We tested the hypotheses that (1) rumination predicts the maintenance of PTSD and depression and (2) reduced concreteness of ruminative thinking may be a maintaining factor. Rumination significantly predicted PTSD and depression at 6 months over and above what could be predicted from initial symptom levels. In contrast to the second hypothesis, reduced concreteness in an iterative rumination task was not significantly correlated with self-reported rumination frequency, and did not consistently correlate with symptom severity measures. However, multiple regression analyses showed that the combination of reduced concreteness and self-reported frequency of rumination predicted subsequent PTSD better than rumination frequency alone. The results support the view that rumination is an important maintaining factor of trauma-related emotional disorders

Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial

Background: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. Methods. The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α =.05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. Discussion. The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed. Trial registration. German Register of Clinical Studies (DRKS): DRKS00004749. © 2013 Heber et al.; licensee BioMed Central Ltd