Lingering effects of COVID-19 on the mental health of first-year university students in Japan

Background The coronavirus disease 2019 (COVID-19) pandemic is continuing unabated in Japan, as of October 2021. We aimed to compare first-year university students’ psychological distress before the pandemic in 2019, during the pandemic in 2020, and one year after the onset of the pandemic, in 2021. Methods The study conducted online surveys over three years from April to May each year. Participants were 400 first-year students in 2019, 766 in 2020, and 738 in 2021. We examined differences in scores on the Counseling Center Assessment of Psychological Symptoms—Japanese version (CCAPS-Japanese) between the three years using a one-way analysis of variance, and differences in the CCAPS-Japanese critical items using chi-squared test and residual analysis. Results The average scores on the Depression and Generalized Anxiety subscale in 2021 were significantly higher than those in 2020, but remained the same as in 2019. The Academic Distress subscale score in 2020 was the worst compared to 2019 and 2021. Meanwhile, the number of students who experienced severe suicidal ideation increased year by year from 2019 to 2021. Conclusion The mean mental health of first-year university students worsened after the onset of the COVID-19 pandemic, and recovered to the pre-pandemic level over the next two years. However, the number of high-risk students with suicidal ideation continued to increase. A system is required for early detection and support for students at high risk of mental health issues.

Volume of Amygdala Subregions and Clinical Manifestations in Patients With First-Episode, Drug-Naïve Major Depression

We examined amygdala subregion volumes in patients with a first episode of major depression (MD) and in healthy subjects. Covariate-adjusted linear regression was performed to compare the MD and healthy groups, and adjustments for age, gender, and total estimated intracranial volume showed no differences in amygdala subregion volumes between the healthy and MD groups. Within the MD group, we examined the association between amygdala subregion volume and the 17-item Hamilton Rating Scale for Depression (HAMD) score and the HAMD subscale score, and found no association in the left amygdala. In the right amygdala, however, there was an inverse linear association between the HAMD total and the HAMD core and lateral nucleus and anterior-amygdaloid-regions. Furthermore, an inverse linear association was seen between the HAMD psychic and the lateral nucleus, anterior-amygdaloid-regions, transition, and whole amygdala. The findings of this study suggest that the severity of MD and some symptoms of MD are associated with right amygdala volume. There have been few reports on the relationship between MD and amygdala subregional volume, and further research is needed to accumulate more data for further validation.

The Effectiveness of Non-clozapine Antipsychotics Combined with Electroconvulsive Therapy versus Clozapine Combined with Electroconvulsive Therapy for Treatment-resistant Schizophrenia

The study aimed to compare the effectiveness and safety of other atypical antipsychotics (non-clozapine) plus electroconvulsive therapy (ECT) (NC+ECT) versus clozapine plus ECT (C+ECT) for treating treatment-resistant schizophrenia (TRS). Data of 32 patients with TRS who was receiving ECT were analysed. We compared clinical characteristics, response to treatment [defined as an improvement of 40% in the Brief Psychotic Rating Scale (BPRS) psychotic symptom subscale from pretreatment scores], change of Mini-mental Status Exam (MMSE) scores, and other adverse effects between the NC+ECT group (N= 16) and C+ECT group (N =16). We found that the overall response rate was 65.6% (75.8% for the NC+ECT group and 56.3% for the C+ECT group, p=0.26). The overall BPRS score in both groups decreased significantly. The mean difference in total BPRS psychotic subscale score between pre-ECT and after last ECT was 10.4 + 5.8 (p<0.001) for the NC+ECT group and 6.6 + 7.3 (p = 0.002) for the C+ECT group. When comparing the NC+ECT group to the C+ECT group, the mean difference in total BPRS psychotic subscale score was not significant. (p = 0.104). The mean difference in MMSE score between pre-ECT and after the last ECT was -1.1 + 5.1 (p =0.45) for the NC+ECT group and 0.2 + 4.3 (p=0.855) for the C+ECT group. The change of MMSE score in the NC+ECT group was not significant different compare to the C+ECT group (p = 0.461). We concluded the combination of antipsychotics and ECT is an effective and safe treatment option for patients with TRS. Other NC+ECT groups’ efficacy may be comparable to that of clozapine plus ECT.

Efficacy of Spironolactone As an Adjunctive Therapy to Risperidone to Improve Symptoms of Schizophrenia; A Double-Blind, Randomized, Placebo-Controlled, Clinical Trial

Objective: Spironolactone (C24H32O4S), a potent mineralocorticoid receptor (MR) inhibitor, is a potassium-sparing diuretic that is traditionally used to treat fluid build-up in the body or for its anti-androgenic properties. This study is a double-blind, placebo-controlled, randomized clinical trial assessing the beneficial effects of spironolactone in addition to risperidone in improving negative symptoms of schizophrenia. Method: 40 patients with chronic schizophrenia, aged 18–60 years, were assigned to two groups: risperidone + spironolactone or risperidone + placebo. Risperidone was administered to both the spironolactone and placebo groups with a dose up to 6 mg/day throughout the trial. Spironolactone (C24H32O4S) was ordered 100 mg/day for the full 8-week course of the study. Patients were rated on the Positive and Negative Syndrome Scale (PANSS) at four time points: baseline, weeks two, four, and eight. The PANSS negative subscale score was the main objective. Results: PANSS negative, positive, and total scores showed significantly greater improvements in the spironolactone relative to the placebo group from baseline to the trial endpoint (P (Cohen’s d): 0.004 (0.96), 0.007 (0.90), and 0.042 (0.66), respectively). Similarly, ANOVA also presented significant time × treatment interaction effect for spironolactone on PANSS negative (F = 9.04; ηp2 = 0.19; df = 1.38; P = 0.002), positive (F = 3.43; ηp2 = 0.08; df = 2.72; P = 0.023), and total (F = 3.94; ηp2 = 0.09; df = 2.05; P = 0.022) scores. However, spironolactone did not cause significant decrease in the general psychiatric pathology score of PANSS. Conclusion: Our findings suggest the efficacy and safety of spironolactone as an adjunctive therapy to risperidone in improving the symptoms of schizophrenia.

Effect of a Mobile Patient Education Application on Adjustment to Stoma and Development of Peristomal Skin Lesions: A Quasi-Experimental Study

BACKGROUND: Patients with a stoma face difficulties in everyday life. A mobile application (app) may assist them in managing their stoma and adjusting to change. PURPOSE: This study developed a mobile app for patients with a stoma and evaluated its effectiveness in improving psychosocial adjustment, self-care, and prevention of peristomal skin lesions. METHODS: The research utilized a quasi-experimental design and was conducted using a posttest control group. The study consisted of 60 patients who had undergone surgery in 3 university hospitals in Istanbul, Turkey, from November 2018 through December 2019. The experimental group (n = 30) used the STOMA-M mobile app, and the control group (n = 30) used an educational booklet that contained images and text that correlated to the content found in the app. Data collection was carried out using an individual characteristics assessment form, Ostomy Adjustment Inventory (OAI-23), Peristomal Skin Lesions Assessment and Classification Instrument, and a stoma care training evaluation form in the first and third months after discharge. Data were analyzed using IBM SPSS Statistics 22.0 software. RESULTS: Sociodemographic characteristics of individuals in the experimental and control groups were similar; 70% (n = 42) required stoma placement because of cancer treatment. More than half of the participants (53.3%; n = 32) had an ileostomy, and 78.3% (n = 47) had a temporary, open stoma. The experimental group’s OAI-23 score, social engagement subscale score, stoma care status, and satisfaction with education e high. The OAI-23 scores in the control group were not significant, and their anger subscale score and the score of item 16, Caring for my stoma is difficult, decreased in the third month compared with baseline. Peristomal skin lesions did not develop in the control group at the third month of follow-up. CONCLUSION: The levels of adjustment to stoma, ability to care for the stoma themselves, and satisfaction with education received were higher in individuals using the mobile app compared with those using the printed booklet. However, the app was not effective in preventing peristomal skin lesions. Additional studies are needed to determine what features of a mobile app may be useful for preventing such lesions.

Psychometric evaluation of the 8-item Altarum Consumer Engagement (ACE) Measure™ in community-dwelling adults in Singapore

Background A valid and reliable measure is essential to assess patient engagement and its impact on health outcomes. This study aimed to examine the psychometric properties of the 8-item Altarum Consumer Engagement Measure™ (ACE Measure) among English-speaking community-dwelling adults in Singapore. Methods This cross-sectional study involved 400 randomly selected community-dwelling adults (mean age: 49.7 years, 50.0% were female, 72.3% were Chinese) who completed the English version of the 8-item ACE Measure independently. The item-level statistics were described. The internal consistency of the measure was measured by Cronbach alpha and item-rest correlations. Validity of the tool was assessed by 1) factorial validity using confirmatory factor analysis (CFA), 2) hypothesis-testing validity by correlating ACE subscales (Commitment and Navigation) with health-related outcomes, and 3) criterion validity against the Patient Activation Measure and Health Confidence Measure. Results There was no floor or ceiling effect for Commitment and Navigation subscales, and the Cronbach alpha for each subscale was 0.76 and 0.54, respectively. The two-factor structure was confirmed by CFA. In general, Commitment and Navigation subscales were positively correlated with frequency of activity participation (rho = 0.30 - 0.33) and EQ-5D visual analog scale (rho = 0.15 - 0.30). Individuals who perceived better health than peers had higher subscale scores (p < 0.01). Each subscale score had moderate and positive correlations with activation score (rho = 0.48 - 0.55) and health confidence score (rho = 0.35 - 0.47). Conclusions The two-subscale ACE Measure demonstrated good construct validity in English-speaking Singapore community-dwelling adults. Evidence in internal consistency was mixed, indicating further investigation.

Effects of Mental Training Through Imagery on the Competitive Anxiety of Adolescent Tennis Players Fasting During Ramadan: A Randomized, Controlled Experimental Study

This study aimed to analyze the effects of mental training through imagery on the competitive anxiety of adolescent tennis players fasting during Ramadan. This is an experimental study conducted with 38 male tennis players, randomly allocated to two groups: an experimental group (EG, n = 18), aged 16.9 ± 0.6 years, and a control group (CG, n = 20), aged 16.7 ± 0.8 years. The study was designed as a randomized, controlled experimental trial (registration code PACTR 202006847771700). CG watched historical videos of the Olympics, while EG performed mental training. The competitive anxiety state assessment was recorded four times. The first measurement was carried out 1 week before Ramadan, the second measurement during the first week of the month, the third measurement at the end of the second week, and, finally, the fourth measurement during the fourth week of Ramadan. Our results revealed a significant interaction (time × groups) for all competitive anxiety subscales. Higher intensity and direction scores for the cognitive and somatic anxiety subscales during Ramadan compared with before Ramadan for both groups could be reported at P &lt; 0.001. Higher intensity and direction scores for the cognitive and somatic anxiety subscales during Ramadan compared with pre-Ramadan for both groups could be found at P &lt; 0.01. This increase in scores was greater for the CG than for the EG in the middle and at the end of Ramadan at P &lt; 0.001. Finally, for the self-confidence subscale score, results revealed that intensity and direction scores were lower during Ramadan compared with pre-Ramadan for the two groups at P &lt; 0.01. The score for the intensity of self-confidence was higher for the EG compared with the CG at the end of Ramadan at P &lt; 0.001. It was concluded that mental imagery training was effective in reducing anxiety (cognitive and somatic) and increasing self-confidence in the intensity dimension of adolescent tennis players who fast during Ramadan.

Adaptation and Validation of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) in People Living with HIV in Myanmar

Objectives Valid and reliable instruments for the measurement of mindfulness are crucial for people living with HIV. However, there was no Myanmar version of such an instrument. Methods We adapted the English version of the 12-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) based on standard cross-cultural procedures. By randomly sampling methods, a sample of 248 eligible people living with HIV was contacted from a closed Myanmar Facebook group; 159 PLHIV completed the initial 12-item version of the adapted survey. Results Three items were removed due to low item-to-total correlations of the corrected item-total correlation as well as having infit and outfit mean squares outside the range of 0.6 to 1.4. After deleting the 3 items, the three-factor structure was confirmed by confirmatory factor analysis, which indicated good model fit. The resultant 9-item CAMS-R in Myanmar (CAMS-R-M-2) achieved good internal reliability (Cronbach’s α of 0.75 to 0.87, and the corrected item-total correlation ranged from 0.44 to 0.81). Construct validity of the scale was demonstrated by significant association with self-reported HIV stigma and social support levels (r = 0.63, and − 0.53). In Rasch analysis, the infit and outfit mean squares for each item ranged from 0.49 to 1.24, and the person reliability was 2.17 and the separation index was 0.83. Conclusions The 9-item CAMS-R-M-2 with a three-factor structure has good reliability and validity. Higher total scores and subscale score reflected greater mindfulness qualities in people living with HIV in Myanmar.

Screening Patients With Metastatic Breast Cancer for Psychiatric Disease: a Cross Sectional Study

Objective: To evaluate the prevalence of psychiatric disorders in a sample of Portuguese patients with metastatic breast cancer and assess the relationship between these disorders and the characteristics of the oncological disease.Methods: Cross-sectional, single-center study with female patients diagnosed with metastatic breast carcinoma and under palliative treatment between November 2020 and May 2021. Psychiatric disorders were screened by applying and filling-out the MMSE, HADS, BSI, and WHOQoL-Bref instruments at the outpatient daycare unit when patients were present for treatmen. Results: A total of 91 female patients were included, median age 59.79 years. None of the patients had cognitive impairment (MMSE). HADS scale: 18.7% of the patients scored for anxiety and 17.6% for depression. The anxiety subscale score of > 8 (HADS) was related to ovarian function suppression (p<0.001), neoadjuvant therapy (p<0.001), and type of second-line of palliative treatment (p=0.024). The depression subscale score >8 (HADS) was related to the type of surgery performed (p= 0.022), molecular subtype of the tumor (p=0.020), and occurrence of grade 3-4 toxicities in the first (p=0.018), and third-line treatments (p=0.031).Conclusion: The screening of psychiatric disorders through the application of these scales by the medical oncology team may be able to aid in diagnosis and potentially lead to psychiatric referral and intervention at an earlier stage.

Clinically Important Difference for the FACIT-Fatigue Scale in Paroxysmal Nocturnal Hemoglobinuria: A Derivation from International PNH Registry Patient Data

Background: Fatigue is a common symptom associated with paroxysmal nocturnal hemoglobinuria (PNH). Eculizumab, a C5 inhibitor approved for treatment of PNH, has been shown to significantly alleviate fatigue, as indicated by reduced scores on the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). FACIT-Fatigue scores range from 0-52 (higher scores indicate less fatigue); this assessment is validated for use in patients with PNH and has been used extensively both in clinical trials and in the International PNH Registry. In patients with cancer, the FACIT-Fatigue clinically important difference (CID) is estimated to be improvement of 3-5 points. This CID is commonly applied in PNH studies; however, no disease-specific CID for FACIT-Fatigue has been estimated in patients with PNH. A PNH-specific CID would be informative in evaluating changes in fatigue impact and could serve as a more robust criterion for evaluating treatment efficacy. The objective of this analysis was to determine the FACIT-Fatigue CID for patients with PNH using distribution- and anchor-based approaches and real-world data from the International PNH Registry. Methods: Adults with PNH who initiated eculizumab within 28 days of enrollment in the PNH Registry as of January 2021 with non-missing baseline FACIT-Fatigue scores were included in the analysis. FACIT-Fatigue scores were assessed at baseline and 6, 12, 24, and 36 months. Two distribution-based CID estimates were calculated using: 1) 0.5 × SD and 2) standard error of measurement (SEM). The SEM was calculated as SD−sqrt(1-α), where α represents the internal consistency measurement Cronbach's alpha. Cronbach's alpha was calculated from the 13 FACIT-Fatigue subscales. Anchor-based estimates considered 2 continuous patient-reported outcome variables: 1) European Organization for Research and Treatment of Cancer (EORTC) Global Health Status Quality of Life (QoL) summary score (quartiles; higher scores indicate better quality of life), and 2) EORTC Global Health Status Fatigue Subscale score (quartiles; lower scores indicate less fatigue). The baseline FACIT-Fatigue score was calculated for each predefined categorization of the anchors; the mean of differences in FACIT-Fatigue between adjacent categories was calculated and referenced as the anchor-based CID. Changes in anchors and high disease activity (HDA) shift from baseline to each follow-up visit were then assessed by FACIT-Fatigue score change (≤1 CID, no change, or ≥1 CID). HDA was defined as lactate dehydrogenase ratio ≥1.5 × upper limit of normal and ≥1 of the following: history of a major adverse vascular event (including a thrombotic event); anemia; or physician-reported abdominal pain, dyspnea, dysphagia, fatigue, hemoglobinuria, or erectile dysfunction. Results: 423 patients were included in the analysis (Table). The majority of patients were white or of Caucasian descent (84%); 3% were of Hispanic or Latino ethnicity. At baseline, 93% of patients had physician documentation of fatigue in their medical history (mean FACIT-Fatigue score, 29.4). The 2 distribution-based CIDs were 7 using 0.5 × SD and 5 using SEM; internal consistency was high (α=0.87). For anchor-based measurements, the CID was 8 using the EORTC QoL score and 10 using the EORTC fatigue subscale score. The percentage of patients who changed from having HDA at baseline to no HDA at eculizumab-treated follow-up visits increased over time. Using the SEM as the referent CID (owing to the high α value), the majority of these patients experienced &gt;1 CID in FACIT-Fatigue that was sustained through 36 months (Figure). Results were similar when 0.5 × SD was used. Conclusion: Collectively, these results support the use of 5 points as the CID for FACIT-Fatigue in individual patients with PNH, which, although not necessarily the minimal value, is close to the range of CIDs reported in other diseases (3-5 points). This finding, obtained from a real-world dataset with a large number of patients, helps establish an important metric for assessment of the meaningful treatment response of patients with PNH. Of note, this CID is markedly smaller than the group average FACIT-Fatigue improvement of 10 points achieved with long-term eculizumab treatment in the pivotal blinded Phase 3 TRIUMPH study. Figure 1 Figure 1. Disclosures Cella: FACIT: Membership on an entity's Board of Directors or advisory committees. Ueda: Sanofi: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Chugai Pharmaceutical: Consultancy, Honoraria, Research Funding; Alexion Pharma: Consultancy, Honoraria. Tomazos: Alexion, AstraZeneca Rare Disease: Current Employment. Gustovic: Alexion, AstraZeneca Rare Disease: Current Employment. Wang: Alexion, AstraZeneca Rare Disease: Current Employment. Patel: Alexion, AstraZeneca Rare Disease: Current Employment. Schrezenmeier: Novartis: Honoraria; Alexion, AstraZeneca Rare Disease: Honoraria, Other: Travel support, Research Funding; Roche: Honoraria; Apellis: Honoraria; Sanofi: Honoraria.