Randomized Controlled Trial on Imaginal Retraining for Problematic Alcohol Use: A Dismantling Study.

Imaginal retraining (IR) is an approach-avoidance procedure that has shown promising results in previous studies. The aim of the present study was to dismantle the efficacy of IR's components in a randomized controlled trial (RCT). We conducted a RCT with nine conditions comprising eight intervention groups and a waitlist control group (WLC). Alcohol craving (primary outcome), consumption, depressive symptoms, quality of life, subjective appraisal, and side effects were assessed online at baseline, post intervention (6 weeks), and follow-up (12 weeks). The sample consisted of 426 participants (age: M = 47.22, SD = 11.82, women: 50.5%). The intervention groups received instructions for four different components of IR (mood induction, mental avoidance of unhealthy stimuli, motor avoidance of unhealthy stimuli, approach to healthy stimuli) that were each conveyed with or without prior psychoeducation (PE). The intervention was delivered online. At total of 163 individuals (42.9%) used the intervention at least once. No group differences were found for any primary or secondary outcome after Sidák correction. Uncorrected statistics showed effects of significantly decreased alcohol consumption for the approach + PE group in the intention-to-treat and the merged motor avoidance group in the per-protocol analyses at post assessment compared with the WLC. Exploratory moderation analyses revealed that individuals with high visualization skills benefited most. The authors conclude that visualization training and motivational components may increase the efficacy and adherence of IR.

Reducing problematic pornography use with imaginal retraining-A randomized controlled trial.

Background and aim: Problematic pornography use (PPU) can be a manifestation of compulsive sexual behavior disorder (CSBD). Studies investigating PPU confirm approach-avoidance tendencies in response to pornographic stimuli in this population. This study show indications of the significance of the efficacy of imaginal retraining, a variant of approach bias modification, as an intervention for PPU. Methods: A total of 274 participants (86.5% male; mean age = 30.65, SD = 10.13) with self-reported PPU were randomized to imaginal retraining (instruction video) or a waitlist control group. Assessments were conducted online at baseline and after the six-week intervention period. The primary outcome was a reduction in problematic pornography use. Compulsive sexual behavior, sexual desire, depressiveness, and satisfaction with the intervention served as secondary outcomes. Results: Retention was low (51.7%), but comparable between groups. The retraining was performed at least once a week (the per-protocol [PP] criterion) by 51.4% of participants. The PP analyses of 111 participants showed a significant reduction in problematic pornography use (primary outcome) in the intervention compared to the control group. The intention-to-treat analyses (ITT), however, did not corroborate this result. Despite low adherence, participants rated their satisfaction with the intervention positively. Discussion and Conclusion: Imaginal retraining can function as a low-threshold self-help intervention for PPU to overcome help-seeking barriers and may reduce PPU in a subgroup of users. Low adherence limits the results of this trial. Given the need for low-threshold interventions for PPU and/or CSBD, further research should focus on increasing adherence and should evaluate retraining for clinical groups. Modifications to augment efficacy are suggested.

Who benefits from indirect prevention and treatment of depression using an online intervention for insomnia? Results from an individual-participant data meta-analysis.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics. METHODS: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree. RESULTS: IPD were obtained from four of seven eligible studies (N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment (d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up (d = -0.84 [95% CI -1.11 to -0.57]). In the subsample (n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators. CONCLUSIONS: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.

Too much of a good thing? Hand hygiene and the long-term course of contamination-related obsessive-compulsive symptoms.

Increased hygiene behavior may be a factor in the development of contamination-related obsessive-compulsive symptoms (C-OCS). We aimed at investigating (1) the course of C-OCS over 1 year after the start of the COVID-19 pandemic and (2) the effects of changes in hand hygiene (i.e., duration and frequency of handwashing) and related distress regulation on the long-term course of C-OCS. In a longitudinal study, we assessed 1,220 individuals from the German general population at the start of the COVID-19 pandemic (t1), 3 months later (t2), and 12 months later (t3). Pre-pandemic data were available in a subsample from 2014 (n = 430). A decrease in C-OCS over the first year of the pandemic emerged with a small effect size. Thirty-six percent of the participants scored above the clinical cut-off score at t1, 31% at t2, and 27% at t3. In 2014, only 11% scored above the clinical cut-off score. Hierarchical regression showed that C-OCS at t1 was the strongest predictor of a long-term increase in C-OCS. With small effect sizes, change in the duration (not frequency) of handwashing from t1 to t2, as well as the distress-reducing effect of handwashing served as additional predictors. Implications for information on hand hygiene guidelines are discussed.

Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers.

BACKGROUND: Considered one of the highest levels of evidence, results of randomized controlled trials (RCTs) remain an essential building block in mental health research. They are frequently used to confirm that an intervention "works" and to guide treatment decisions. Given their importance in the field, it is concerning that the quality of many RCT evaluations in mental health research remains poor. Common errors range from inadequate missing data handling and inappropriate analyses (e.g., baseline randomization tests or analyses of within-group changes) to unduly interpretations of trial results and insufficient reporting. These deficiencies pose a threat to the robustness of mental health research and its impact on patient care. Many of these issues may be avoided in the future if mental health researchers are provided with a better understanding of what constitutes a high-quality RCT evaluation. METHODS: In this primer article, we give an introduction to core concepts and caveats of clinical trial evaluations in mental health research. We also show how to implement current best practices using open-source statistical software. RESULTS: Drawing on Rubin's potential outcome framework, we describe that RCTs put us in a privileged position to study causality by ensuring that the potential outcomes of the randomized groups become exchangeable. We discuss how missing data can threaten the validity of our results if dropouts systematically differ from non-dropouts, introduce trial estimands as a way to co-align analyses with the goals of the evaluation, and explain how to set up an appropriate analysis model to test the treatment effect at one or several assessment points. A novice-friendly tutorial is provided alongside this primer. It lays out concepts in greater detail and showcases how to implement techniques using the statistical software R, based on a real-world RCT dataset. DISCUSSION: Many problems of RCTs already arise at the design stage, and we examine some avoidable and unavoidable "weak spots" of this design in mental health research. For instance, we discuss how lack of prospective registration can give way to issues like outcome switching and selective reporting, how allegiance biases can inflate effect estimates, review recommendations and challenges in blinding patients in mental health RCTs, and describe problems arising from underpowered trials. Lastly, we discuss why not all randomized trials necessarily have a limited external validity and examine how RCTs relate to ongoing efforts to personalize mental health care.