Excessive and persistent fear of clusters of holes, also known as trypophobia, has been suggested to reflect cortical hyperexcitability and may be associated with mental health risks. No study, however, has yet examined these associations in representative epidemiological samples.

To examine the prevalence of trypophobia in a population-representative youth sample, its association with mental health and functioning, and its interaction with external stress.

A total of 2065 young people were consecutively recruited from a household-based epidemiological youth mental health study in Hong Kong. Trypophobia, symptoms of anxiety, depression and stress, and exposure to personal stressors were assessed. Logistic regression was used to assess the relationships between trypophobia and mental health. Potential additive and interaction effects of trypophobia and high stress exposure on mental health were also tested.

The prevalence of trypophobia was 17.6%. Trypophobia was significantly associated with severe symptoms of anxiety (odds ratio (OR) = 1.83, 95% CI = 1.32–2.53), depression (OR = 1.78, 95% CI = 1.24–2.56) and stress (OR = 1.68, 95% CI = 1.11–2.53), even when accounting for sociodemographic factors, personal and family psychiatric history, resilience and stress exposure. Dose–response relationships were observed, and trypophobia significantly potentiated the effects of stress exposure on symptom outcomes, particularly for depressive symptoms. Those with trypophobia also showed significantly poorer functioning across domains and poorer health-related quality of life.

Screening for trypophobia in young people may facilitate early risk detection and intervention, particularly among those with recent stress exposure. Nevertheless, the generally small effect sizes suggest that other factors have more prominent roles in determining recent mental health outcomes in population-based samples; these should be explored in future work.

Clinical trials provide the “gold standard” evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources – data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor.

Three examples of real-world trials that leverage different types of data sources – wearables, medical devices, and electronic health records are described. Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived.

Insight and recommendations are given on four topic areas: A. Charge of the DSMB; B. Composition of the DSMB; C. Pre-launch Activities; and D. Post-launch Activities. We recommend stronger and additional focus on data integrity.

Clinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. The data, however, present a level of informatic complexity that relies heavily on a robust data science infrastructure. The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials.

Despite replicated cross-sectional evidence of aberrant levels of peripheral inflammatory markers in individuals with major depressive disorder (MDD), there is limited literature on associations between inflammatory tone and response to sequential pharmacotherapies.

To assess associations between plasma levels of pro-inflammatory markers and treatment response to escitalopram and adjunctive aripiprazole in adults with MDD.

In a 16-week open-label clinical trial, 211 participants with MDD were treated with escitalopram 10– 20 mg daily for 8 weeks. Responders continued on escitalopram while non-responders received adjunctive aripiprazole 2–10 mg daily for 8 weeks. Plasma levels of pro-inflammatory markers – C-reactive protein, Interleukin (IL)-1β, IL-6, IL-17, Interferon gamma (IFN)-Γ, Tumour Necrosis Factor (TNF)-α, and Chemokine C–C motif ligand-2 (CCL-2) - measured at baseline, and after 2, 8 and 16 weeks were included in logistic regression analyses to assess associations between inflammatory markers and treatment response.

Pre-treatment levels of IFN-Γ and CCL-2 were significantly higher in escitalopram non-responders compared to responders. Pre-treatment IFN-Γ and CCL-2 levels were significantly associated with a lower of odds of response to escitalopram at 8 weeks. Increases in CCL-2 levels from weeks 8 to 16 in escitalopram non-responders were significantly associated with higher odds of non-response to adjunctive aripiprazole at week 16.

Pre-treatment levels of IFN-Γ and CCL-2 were predictive of response to escitalopram. Increasing levels of these pro-inflammatory markers may predict non-response to adjunctive aripiprazole. These findings require validation in independent clinical populations.

None Declared

Undergraduate students encounter developmental challenges during their transition into adulthood. Previous studies have claimed that adults with later chronotypes usually manifest negative psychological effects: poor sleep quality, greater stress, depression, and cognitive dysfunction. However, knowledge about the relationship between chronotype, stress, and sleep quality among young adults is lacking.

The present study investigated the relationship between undergraduates’ chronotypes and perceived stress on sleep quality.

An online survey with a descriptive, cross-sectional design was conducted with a convenience sample of undergraduate students at a university in southern Taiwan. Those who were 20-25 years old and enrolled as a student were included; but who had been suspended or had deferred graduation were excluded. Students’ chronotype, stress, and sleep quality were assessed with three self-reported instruments: Munich Chronotype Questionnaire (MCTQ), Perceived Stress Scale (PSS), and Pittsburgh Sleep Quality Index (PSQI).

Of 161 undergraduates who completed the questionnaires, 51 reported using an alarm clock to wake and were removed from data analysis. One hundred and ten students’ mean age is 20.3 and perceived moderate stress. Sixty-one percent were poor-quality sleepers. The mean chronotype score was 5.7, and 85.5% had an intermediate chronotype, while 13.6% had an evening chronotype. Chronotype and perceived stress were positively correlated with sleep quality (p < .001). Social jetlag was positively correlated with chronotype (p =.036). Undergraduate’s later chronotype and higher stress perception predicted 30% of poorer sleep quality (p < .001).

Undergraduate students’ chronotype and perceived stress were positively correlated and acted as predictors of the sleep quality. The findings could help to develop health-promotion interventions for these emerging adults to adjust their daily routines; and reduce their social jetlag, stress levels, and sleep disturbance.

None Declared

Mental Health Literacy (MHL) includes four distinct but interrelated components: maintenance of positive mental health (MH), recognition of mental disorders (R), mental illness stigma attitudes (S), and help-seeking efficacy (E). A fifth component, help-seeking attitude (A) was included in a MHL model because it is a strong predictor of help-seeking behaviors. The five-factor model of MHL has been validated previously. In the study of multiple mediation model of MHL, it demonstrated the mediation role of help-seeking efficacy between recognition of mental disorders and help-seeking attitude (R-E-A path), but the roles of mental illness stigma attitudes or maintenance of positive mental health remain unknown.

The present study aimed to examine the theory-based multifaceted MHL model by utilizing a meta-analytic structural equation modeling analyses (MASEM) method.

Systematic search of articles from electronic databases, including APA PsycArticles, ERIC, MEDLINE, Psychology and Behavioral Sciences Collection, Pubmed, and Airiti Library (Chinese), from inception up to July 31, 2022, was conducted by raters independently assessed study eligibility, and extracted 127 empirical, quantitative, non-interventional studies with properly reported effect sizes (k=192). MASEM analyses were conducted via a two-stage approach. First, a pooled correlation matrix was obtained for each mediation model by applying a multivariate random-effects model using Comprehensive Meta-Analysis Version 3.3. Second, a structural equation model was fitted on the pooled correlation matrices to test for mediation effects (i.e., indirect effects) using IBM SPSS Amos.

In the single-mediator model analysis, there was a significant partial mediation effect of help-seeking efficacy and Mental illness stigma attitudes on the relationship between recognition of mental disorders and help-seeking attitude (R-E-A path & R-S-A path, p <.05). The multiple-mediator model has showed adequate fit (RMSEA = 0.09, SRMR = 0.04, CFI = 0.93, GFI = .99). It confirmed the help-seeking efficacy served as a mediator. A sequential mediation of maintenance of positive mental health and mental illness stigma attitudes was found (p <.05) between recognition of mental disorders and help-seeking attitude (R-MH-S-A path).

There is a robust mediation effect of Help-seeking efficacy on the relationship between recognition of mental disorders and help-seeking attitude either in the single mediation model or the multiple mediation model. Furthermore, increased recognition of mental disorder was related to increased maintenance of positive mental health, therefore decreased mental illness stigma attitude, and eventually increased help-seeking attitude. Future research directions regarding pathways in the MHL models were discussed.

None Declared

Individuals who self-harm have increased suicide rates. Brief interventions are associated with reduced repeated suicide attempts. However, very few previous studies investigated the acceptability of brief interventions before implementing new trials.

We aimed to explore the perceptions of individuals who self-harm toward a brief intervention, the Chinese version of the volitional help sheet (VHS-C), which encourages people to link a critical situation with an appropriate response.

Fourteen participants who presented to hospitals with self-harm were interviewed about their perspectives regarding the acceptability of the paper- and web-based VHS-C. Data were analysed with the framework method.

The participants could understand the intended goal of the VHS-C by reading the written instructions, but indicated that having verbal instructions would also help. They shared the reasons why they felt the VHS-C was helpful (e.g. relatable contents, useful coping strategies and appropriate instructions that made them feel understood) or unhelpful (e.g., being not specific enough, not useful during the crisis and triggering negative emotional responses). Some indicated that the VHS-C might not be applicable to people experiencing ongoing distress in emergency departments. Most participants preferred the web-based to the paper-based VHS-C, and suggested that the format and frequency of follow-up reminders could leave the patient to decide.

The contents of the VHS-C were acceptable for people who presented to hospitals with self-harm. The VHS-C may be more helpful before individuals encounter suicidal thoughts than when they have an ongoing crisis.

It is unknown how much variation in adult mental health problems is associated with differences between societal/cultural groups, over and above differences between individuals.

To test these relative contributions, a consortium of indigenous researchers collected Adult Self-Report (ASR) ratings from 16 906 18- to 59-year-olds in 28 societies that represented seven culture clusters identified in the Global Leadership and Organizational Behavioral Effectiveness study (e.g. Confucian, Anglo). The ASR is scored on 17 problem scales, plus a personal strengths scale. Hierarchical linear modeling estimated variance accounted for by individual differences (including measurement error), society, and culture cluster. Multi-level analyses of covariance tested age and gender effects.

Across the 17 problem scales, the variance accounted for by individual differences ranged from 80.3% for DSM-oriented anxiety problems to 95.2% for DSM-oriented avoidant personality (mean = 90.7%); by society: 3.2% for DSM-oriented somatic problems to 8.0% for DSM-oriented anxiety problems (mean = 6.3%); and by culture cluster: 0.0% for DSM-oriented avoidant personality to 11.6% for DSM-oriented anxiety problems (mean = 3.0%). For strengths, individual differences accounted for 80.8% of variance, societal differences 10.5%, and cultural differences 8.7%. Age and gender had very small effects.

Overall, adults' self-ratings of mental health problems and strengths were associated much more with individual differences than societal/cultural differences, although this varied across scales. These findings support cross-cultural use of standardized measures to assess mental health problems, but urge caution in assessment of personal strengths.

As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward.

In the parent nationwide randomized clinical trial of adult smokers (N = 638), participants could enroll via mail or e-consent. Logistic regression models assessed relationships between sociodemographics and enrollment via mail (vs e-consent). Mailed consent packets were randomized (1:4) to include $5 unconditional reward or not, and logistic regression modeling examined impact of reward on subsequent enrollment, allowing for a randomized study within a study. Incremental cost-effectiveness ratio analysis estimated additional cost per additional participant enrolled with $5 incentive.

Older age, less education, lower income, and female sex predicted enrolling via mail vs e-consent (p < .05’s). In adjusted model, older age (AOR = 1.02, p = .016) and less education (AOR = 2.23, p < .001) remained predictive of mail enrollment. The $5 incentive (vs none) increased enrollment rate by 9% (AOR = 1.64, p = .007), with estimated cost of additional $59 per additional participant enrolled.

As e-consent methods become more common, they have potential to reach many individuals but with perhaps diminished inclusion across all sociodemographic groups. Provision of an unconditional monetary incentive is possibly a cost-effective mechanism to increase recruitment efficiency for studies employing mail-based consenting procedures.

This paper used data from the Apathy in Dementia Methylphenidate Trial 2 (NCT02346201) to conduct a planned cost consequence analysis to investigate whether treatment of apathy with methylphenidate is economically attractive.

A total of 167 patients with clinically significant apathy randomized to either methylphenidate or placebo were included. The Resource Utilization in Dementia Lite instrument assessed resource utilization for the past 30 days and the EuroQol five dimension five level questionnaire assessed health utility at baseline, 3 months, and 6 months. Resources were converted to costs using standard sources and reported in 2021 USD. A repeated measures analysis of variance compared change in costs and utility over time between the treatment and placebo groups. A binary logistic regression was used to assess cost predictors.

Costs were not significantly different between groups whether the cost of methylphenidate was excluded (F(2,330) = 0.626, ηp 2 = 0.004, p = 0.535) or included (F(2,330) = 0.629, ηp 2 = 0.004, p = 0.534). Utility improved with methylphenidate treatment as there was a group by time interaction (F(2,330) = 7.525, ηp 2 = 0.044, p < 0.001).

Results from this study indicated that there was no evidence for a difference in resource utilization costs between methylphenidate and placebo treatment. However, utility improved significantly over the 6-month follow-up period. These results can aid in decision-making to improve quality of life in patients with Alzheimer’s disease while considering the burden on the healthcare system.

Computerized-adaptive testing (CAT) may increase reliability or reduce respondent burden for assessing patient-reported outcomes compared with static short forms (SFs). We compared CAT versus SF administration of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric measures in pediatric inflammatory bowel disease (IBD).

Participants completed 4-item CAT, 5- or 6-item CAT, and 4-item SF versions of the PROMIS Pediatric measures. We compared average T-scores, intra-class correlations (ICCs), floor and ceiling effects, and standard error of measurement (SEM) across forms, along with mean effect sizes between active versus quiescent IBD disease activity groups.

Average PROMIS T-scores across forms were <3 points (minimally important difference) of each other. All forms correlated highly with each other (ICCs ≥0.90) and had similar ceiling effects, but the CAT-5/6 had lower floor effects. The CAT-5/6 had lower SEM than the CAT-4 and SF-4, and the CAT-4 had a lower SEM than the SF-4. Mean effect sizes were similar across forms when contrasting disease activity groups.

The CAT and SF forms produced similar score results, but the CAT had better precision and lower floor effects. Researchers should consider PROMIS pediatric CAT if they anticipate that their sample will skew toward symptom extremes.