Preliminary investigation of the feasibility of a long-term but low-frequency preventive intervention for depression in Japanese high schools.

AIM: We explored the feasibility of a long-term but low-frequency psychological preventive intervention in a high school setting. BACKGROUND: High school students may experience depression; psychological interventions to improve social and cognitive skills may be useful to decrease such depression. A long-term but low-frequency intervention may be feasible in this setting because of its minimal time demands and lack of need for specialist human resources DESIGN: We conducted a single-arm longitudinal descriptive study with an intervention applied six times over 2 years in one high school. METHOD: We conducted a psychological preventive intervention with 94 high school students in one school for 2 years (April 2014 to March 2016). This intervention aimed to improve social and cognitive skills. We measured social skills, cognitive distortion, and depression five times during the 2-year period, through a self-report scale. RESULTS/FINDINGS: Scores for maintaining relationship skills tended to increase over the 2 years. However, depression did not decrease over the intervention period. CONCLUSION: Although our research did not include control conditions and the intervention did not decrease depression, the six-session programme for high school adolescents improved an aspect of social skills that is a preventive factor against depression.

Reliability and validity of the Children's Depression Inventory-Japanese version.

BACKGROUND: Depression has major negative consequences for individuals and society, and psychological assessment tools for early disease detection are needed. The aim of this study was to investigate the reliability and validity of an updated Japanese version of the Children's Depression Inventory (CDI-J) and set a cut-off score for the detection of depression. METHODS: The participants consisted of 465 children and adolescents aged 7-17 years. The control (CON) groups consisted of students recruited from elementary and junior-high school (CONEJ) and children recruited from among hospital staff members (CONRE), while the outpatient clinical (OPC) groups consisted of pediatric psychosomatic outpatients (OPCPD) and adolescent psychiatric outpatients (OPCPS). The CON and OPC CDI-J scores underwent factor analysis using varimax rotation, followed by measurement invariance analysis. The Youth Self-Report (YSR) was administered to assess concurrent validity. The Mini-International Neuropsychiatric Interview was administered to the OPC group to diagnose current depressive symptoms. Receiver operating characteristics (ROC) analysis was conducted to evaluate case-finding performance and to set cut-off points for the detection of depression. RESULTS: The CDI-J was reliable in terms of internal consistency (Cronbach α = 0.86; mean inter-item correlation, 0.16). Re-test reliability was substantial (mean interval 18 days: γ = 0.59, P < 0.05). The four-factor solution exhibited adequate internal consistency (range, 0.52-0.73) and correspondence (Pearson correlation of 0.65 with the YSR) for both the CON and OPC groups. On ROC analysis the optimal cut-off score was 23/24. CONCLUSION: The CDI-J can be used as a reliable and well-validated instrument alongside standard diagnostic procedures.

Behavioral activation for late adolescents with subthreshold depression: a randomized controlled trial.

The main behavioral characteristic of subthreshold depression that is observed in adolescents is the low frequency of exposure to environmental rewards. Therefore, it was considered that a simple intervention conducted in short sessions, focusing on increasing access to positively reinforcing activities, would be efficacious in increasing the availability of rewards. We conduct a randomized controlled trial to examine the efficacy of such a behavioral activation program that was conducted weekly for 5 weeks in 60-min sessions. Late adolescent university students aged 18-19 years with subthreshold depression were randomly allocated to a treatment (n = 62) or a control group (n = 56). The primary outcome of the study was the Beck Depression Inventory-II score. Results indicated that late adolescent students in the treatment group showed significant improvements in their depressive symptoms (effect size -0.90, 95 % CI -1.28 to -0.51) compared to the control group. Students in the treatment group also showed significant improvements in self-reported rating of quality of life and in behavioral characteristics. It is concluded that this intervention had a large and significant effect despite being short and simple and that this low-intensity cognitive behavioral therapy program could be conducted in many different types of institutions. It is suggested that the long-term effects of the treatment program should be targeted for investigation in future studies.

Psychosocial difficulties in adolescent and young adult survivors of childhood cancer.

BACKGROUND: With a large number of children surviving cancer worldwide, numerous investigations have assessed psychological and social adjustment among childhood cancer survivors. According to these studies, it is unclear whether childhood cancer survivors successfully adjust to daily life after being discharged from hospital, especially for adolescent and young adult survivors who have unique needs and concerns. The primary aim of this study was to identify the factors underlying psychosocial difficulties faced by adolescent and young adult survivors in their day-to-day lives after being discharged from hospital. METHODS: Semi-structured interviews were conducted. Twenty-five childhood cancer survivors were recruited from two regional cancer institutions in Japan. Content analysis was applied to the responses. RESULTS: Nineteen attributes were extracted and classified into four categories as follows: physical difficulties, interpersonal difficulties, behavioral difficulties, and uncertainty about the future. The attributes indicated by >50% of the participants were "I am worried about not feeling well," "I have difficulty continuing treatment in daily life," "I have difficulty moving my body," "I have to be absent from school or work because of illness," and "I am left behind academically." CONCLUSIONS: This study identified important factors of psychosocial day-to-day difficulties. Clinically, these results suggest that it is important to watch for these signs and to provide early support to survivors so that their daily life and development are not hindered by the treatment and its side-effects, and to offer long-term support focusing on individual patient characteristics such as sex, age, and cancer history.

A comprehensive study of the distressing experiences and support needs of parents of children with intractable cancer.

OBJECTIVE: The primary endpoints of this study were: (1) to explore the distressing experiences of parents of patients with intractable pediatric cancer in Japan from disclosure of poor prognosis to the present and (2) to explore support they regarded as necessary. METHODS: A multi-center questionnaire survey was conducted that included 135 bereaved parents of patients with pediatric cancer in Japan. RESULTS: The top five distressing experiences shared by over half of the bereaved parents were: 'Realize that the child's disease was getting worse' (96.7%), 'Witness the child's suffering' (96.7%), 'Make many decisions on the basis that the child will die in the not-so-distant future' (83.6%), 'Feel anxious and nervous about the child's acute deterioration' (82.0%) and 'Realize that there was nothing that I could do for the child' (78.7%). The top five support regarded as necessary were: 'Visit the room and speak to the sick child every day' (90.2%), 'Provide up-to-date information' (80.3%), 'Sufficiently explain the disadvantages of each treatment option' (80.3%), 'Show a never-give-up attitude until the end' (78.7%) and 'Make arrangements to allow the sick child to spend time with his/her siblings' (73.8%). CONCLUSIONS: This study identified the common distressing experiences of parents and the support regarded as necessary by them. To provide efficient support with limited manpower in pediatric setting, healthcare professionals should recognize these tasks as high priorities when engage parents of intractable pediatric cancer patients.

Thought habits and processing modes among Japanese university students do not influence dynamic associations between rumination and negative affect.

The integrated model of rumination argues that two trait factors-negative thinking habits and processing modes-get people stuck in maladaptive rumination. There is little evidence showing whether these factors influence the daily dynamic associations between rumination and negative moods. To address this, in this study, we conducted an experience-sampling method on Japanese university students. We recruited 92 Japanese university students and assessed their daily rumination and negative affect (NA) eight times a day for seven days. We examined the effects of habits and processing modes on the dynamic associations between rumination and negative moods using dynamic structural equation modeling. We found that individuals were more likely to ruminate when they experienced NA. However, contrary to previous findings, this study's participants did not experience NA after engaging in rumination. Moreover, we did not detect any significant trait factor effect on these dynamic associations. Our findings imply that individuals are more likely to engage in rumination after experiencing NA, but the reverse association, particularly the autoregression of rumination, may not be maintained in natural daily life. Furthermore, negative thinking habits and processing modes may not influence the daily dynamic associations between rumination and NA among Japanese university students.

Long-term effects of a universal prevention program for depression in children: a 3-year follow-up study.

BACKGROUND: The present study evaluates the long-term effects of a universal prevention approach for depression in children. It looks into the 2- and 3-year follow-ups of previously reported postintervention and 1-year outcomes. METHOD: One hundred and eighty-nine 3rd grade (8-9 years old) children participated in a five-session, school-based, universal prevention program designed to encourage social skills and peer support. The study was conducted from 2006 to 2009 in two public schools in Miyazaki, the south main island of Japan. RESULTS: Depressive symptoms decreased significantly from the pre to the postintervention periods, and this effect was maintained. Furthermore, children in the prevention group showed significantly lower depression than the normative sample. CONCLUSIONS: This study reveals the beneficial long-term effects of a universal approach.

An intervention to promote concrete thinking style in young adults: Effects on depressive symptoms and its protective factors.

BACKGROUND AND OBJECTIVES: Individuals with low concreteness-experiential thought (CET) tend to have exacerbated depressive symptoms. Interventions aimed at increasing CET have been shown to influence depressive symptoms. The present study examined the effects of increasing CET on depressive symptoms and its protective factors. METHODS: A two-armed experimental intervention was conducted with 86 healthy university students in Japan. They were randomly allocated to the intervention and waitlist groups. Participants in the intervention group engaged in an unguided and web-based (UW) intervention to increase CET (UW-CET). This intervention included a one-off session, to explain the rationale behind increasing CET via a psychoeducation video, and a five-session training on CET over a week. We assessed depressive symptoms, thought styles, and protective factors, such as mindfulness and goal striving, both pre- and-post-assessment and at the one-month follow-up. RESULTS: Participants in the intervention group had marginally increased CET in the follow-up assessments; however, participants in the waitlist group did not. Furthermore, participants in the intervention showed marginally increased mindfulness tendencies and strivings toward their personal goals, but their depressive symptoms were not affected. LIMITATIONS: The present study did not include any active control conditions. Additionally, the sample consisted of only healthy university students. CONCLUSIONS: The findings suggest that the UW-CET can marginally increase adaptive thinking, such as CET, and promote positive psychological aspects in healthy young adults; however, the effect is small. The findings may also help expand clinical implementations to prevent depression in young adults.

The development and validation of the multidimensional fear-of-injection scale.

Background: Adults and children alike can feel anxious and afraid of needles. As a result, some people avoid necessary medical injections, leading to health problems. Assessing the fear of injections should consider fear factors, avoidance behaviors, and physical symptoms. We have developed a single scale that measures each of these variables. Conventional fear-of-injection scales do not simultaneously measure the aforementioned components, and thus may not adequately capture the fear of injections. Furthermore, no scale has been developed in Japan to measure the fear of injections. Method: A multidimensional fear-of-injection scale was developed in Study 1. The participants, 419 university students, were administered a questionnaire to check the reliability and validity of the scale. In Study 2, to establish the cut-off value of the scale, we conducted a questionnaire and analyzed the data of 771 university students. The outcome is the multidimensional fear-of-injection scale. Results: The results from factor analysis showed that this scale has a four-factor structure (direct fear, indirect fear, physiological response, and avoidance behaviors). The results of the receiver operating characteristic analysis showed that a cut-off value of 35 points identifies people with a subjective fear of injections. Conclusion: The multidimensional fear-of-injection scale is a comprehensive measure of the fear of injections and serves as an effective indicator for intervention and screening. Additionally, it provides a quantitative assessment of the fear of injection in Japan.

[Relationship between Dose Discontinuation or Dose Reduction for Safety Reasons in Clinical Trials and Lower-dose Prescriptions in the Post-marketing Setting].

Dosage of pharmaceuticals is determined and approved based on pivotal clinical trial results in Phase 3. However, in the post-marketing setting, it is often adjusted according to conditions of individual patients. Some pharmaceuticals are used at a lower dose than the approved dose for safety reasons or in elderly patients. In this study, we examined the relationships between dose discontinuation or dose reduction, for safety reasons as well as participation of elderly patients in clinical trials, and lower-dose prescriptions in the post-marketing setting. We collated the dataset of 113 eligible pharmaceuticals from those that were approved in Japan between 2005 and 2014. Subsequently, we calculated the proportions of patients who withdrew from the study, whose medication was discontinued, or dose reduced due to adverse events, and of elderly patients (over sixty-five years old) to those who were exposed to the approved dose range in the pivotal clinical trials. Then their relationships with lower-dose prescription in the post-marketing setting were examined using Mann-Whitney U test. The proportions of patients who withdrew from the study (p=0.0019), whose medication was discontinued owing to adverse events (p=0.0007), or whose dose was reduced owing to adverse events (p<0.0001) were significantly higher for "lower-dose prescription drugs" than those for other drugs; however, the proportion of elderly patients did not show this significant increase in the "lower-dose prescription drugs" group.

Psychological distress related to patterns of family functioning among Japanese childhood cancer survivors and their parents.

OBJECTIVE: Family functioning appears to be a predictor of psychological distress among childhood cancer survivors and their family members; however, relatively little is known about patterns in those families that are psychologically at-risk. The purpose of this study was to identify distinct clusters of families that include childhood cancer survivors, and to evaluate differences between the clusters with respect to anxiety, depression, and post-traumatic stress symptoms (PTSS). METHODS: Childhood cancer survivors and their parents (247 individuals: 88 adolescent cancer survivors, 87 mothers, and 72 fathers) completed self-report questionnaires. Perceptions of family functioning were assessed using the Family Relationship Index and its three dimensions (cohesiveness, expressiveness, and conflict), and individuals were classified into groups via a cluster analytic approach. State-trait anxiety, depression, and PTSS were assessed to all of the participants. RESULTS: The individuals were classified into three types: One cluster featured high cohesiveness, high expressiveness, and low conflict ('Supportive-type', n=102); a second cluster featured low cohesiveness, low expressiveness, and high conflict ('Conflictive-type', n=32); and a third cluster had moderate cohesiveness, moderate expressiveness, and moderate conflict ('Intermediate-type', n=113). Among the three types, an analysis of variance revealed that 'Conflictive-type' members had the highest levels of PTSS, depression, and state-trait anxiety. CONCLUSIONS: These findings suggest that perceptions of family functioning are related to psychological distress in family members of childhood cancer survivors. A family-focused intervention might be a useful approach to targeting emotional distress in these families, particularly for families with a 'Conflictive-type' family member.

A qualitative study of decision-making by breast cancer patients about telling their children about their illness.

OBJECTIVE: Many breast cancer patients are troubled about telling their school-age children about their illness. However, little attention has been paid to the factors that encourage or discourage them from revealing the illness. This study explored decision-making by breast cancer patients about telling their children about their illness. METHODS: Participants were 30 breast cancer patients recruited from a regional cancer institution in Japan. Semi-structured interviews were conducted and content analysis was performed. RESULTS: Six preparatory stages of decision-making by Japanese breast cancer patients about telling their children about their illness were identified as follows: contemplation, preparation, action-hospitalization and surgery, action-adjuvant therapy, action-diagnosis, and action-prognosis. We also identified 11 categories of positive aspects and ten categories of negative aspects about revealing their illness to children. The categories of negative aspects with higher frequency were similar to those found by previous research, but categories of positive aspects were unique. The rate of reference to negative aspects in total reduces gradually as the preparatory stage advances, and in action-diagnosis and action-prognosis stages the balance between positive and negative aspects becomes about half and half. CONCLUSIONS: Patients, especially in action-hospitalization and surgery, can be expected to tell their children about their illness although they find negative aspects much more compelling than positive aspects and experience great distress. These patients have special needs for support from others.

Reduction of fatigue and anger-hostility by the oral administration of 5-aminolevulinic acid phosphate: a randomized, double-blind, placebo-controlled, parallel study.

Although large populations feel fatigue, the standardized medicinal therapy is currently absent. In this study, we determined whether 5-aminolevulinic acid (5-ALA) supplementation alleviates the feeling of fatigue in healthy subjects who feel chronic physical tiredness. Males and females between ages of 20 and 64 who felt physical fatigue on a daily basis, with a visual analogue scale (VAS) for fatigue ≥ 40 mm, a T-score of Fatigue-Inertia in the Profile of Mood States-Second Edition-Adult (POMS2-A) ≥ 50, and a T-score of Vigor-Activity in POMS2-A ≤ 60 were recruited. Seventy eligible participants were randomly assigned to either a 5-ALA or a placebo group. During the 8 weeks of consumption, the subjects completed VAS questionnaires for fatigue and POMS2-A at 4-week intervals. The VAS values for overall feeling of fatigue and feeling of work-related fatigue, and the Anger-Hostility subscale of POMS2-A were decreased by 5-ALA with significant time × group interaction effects (p = 0.040, 0.020, and 0.045, respectively). Besides, the 5-ALA group showed significant differences in Fatigue-Inertia, Depression-Dejection and Total Mood Disturbance scores, when compared between pre- and post-intervention, while the placebo group did not. In conclusion, the oral administration of 5-ALA improves fatigue and negative mood in subjects who constantly feel physical fatigue.This clinical trial was registered with University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as UMIN000031528 on 2/3/2018.

Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon.

The dosage of pharmaceuticals is determined through the process of clinical development and approval review based on clinical trial results; however, the information obtained from clinical trials before approval is limited. Some pharmaceutical products are used at doses lower than those approved for post-marketing use. The aim of this study was to reveal the actual state of lower-dose prescriptions for post-marketing clinical use of pharmaceuticals. We investigated the factors related to the deviation based on therapeutic area, detailed statement of the approved dosage, clinical data package, and post-marketing requirement. Among the new molecular entities approved in Japan between January 2005 and December 2014, we identified products that are orally administered and have the same daily dose for different indications, if any. For these products, we collected information on the actual daily dose from the medical information databases of Medical Data Vision Co., LTD. and JammNet Co., LTD. Products whose dose was lower than the approved dose (maintenance dose excluding the initial dose) in ≥ 30% prescriptions in 2015 were defined here as "lower-dose prescription drugs." We identified 27 lower-dose prescription drugs out of 113 products investigated. The results of the multivariate analysis revealed that factors related to the Anatomical Therapeutic Chemical classification and the detailed statement of the approved dosage significantly influenced the occurrence of lower-dose prescription, whereas the factors related to clinical data package and post-marketing requirements did not. These results suggest the limitation in determining an optimal dosage for the actual clinical use of a drug based on the information obtained from clinical trials conducted before approval, emphasizing the importance of reexamining the optimal dosage that is applicable to a greater number of patients after marketing, if necessary. We believe that the utilization of real-world data could be of help in this regard.

Impact of repetitive thought and processing mode on goal striving.

BACKGROUND AND OBJECTIVES: Striving to attain personal goals is important for maintaining well-being. Previous research indicates that repetitive thoughts can influence the affect and cognition associated with personal goal strivings. Repetitive thought in the concrete-experiential processing mode improves affect and cognition after a negative event more than does repetitive thought in the abstract-analytic processing mode. We extend this prior work by examining whether repetitive thought directly influences the maintenance of personal goal strivings through a longitudinal survey. METHODS: In Study 1, we examined the daily maintenance effect of repetitive thought on personal goal strivings using a multilevel analysis of 29 participants who reported their thoughts and goal strivings daily for one week. In Study 2, participants (N = 131) reported their thoughts and goal strivings over 10 weeks, and we examined the maintenance effect of repetitive thought on personal goal strivings every two weeks. RESULTS: Highly repetitive thought in the abstract-analytic processing mode decreased the maintenance of short-term personal goal strivings in individuals with difficult goals. However, highly repetitive thought in the concrete-experiential processing mode increased the maintenance of long-term personal goal strivings in individuals with difficult goals. LIMITATIONS: The study participants were university students; therefore, we cannot generalize the results to clinical populations or other age groups. CONCLUSION: Interventions that increase repetitive thought in the concrete-experiential processing mode may be effective in facilitating long-term goal strivings in individuals attempting to overcome difficult situations and achieve important personal goals.

Enduring effects of a 5-week behavioral activation program for subthreshold depression among late adolescents: an exploratory randomized controlled trial.

BACKGROUND: No significant effect of psychological treatment has been reported from meta-analysis of subthreshold depression patients and control subjects at 1-year follow-up. However, behavioral activation is a simpler and more cost-effective treatment than cognitive behavioral therapy. The primary purpose of this study was to assess by comparison to an assessment-only control group whether the effects of behavioral activation program for depressive symptoms can persist up to 1-year follow-up without the use of antidepressants or other psychotherapy. PATIENTS AND METHODS: Late adolescent students were the population targeted in this study. Participants were allocated randomly to an intervention group (n=62) or a control group (n=56). Treatment consisted of five-weekly 60-minute sessions. Participants underwent a structured interview and completed self-report scales at 1 year post-assessment. RESULTS: Late adolescent students receiving treatment had significantly lower mean Beck Depression Inventory, second edition scores at 1-year follow-up than control group students. The effect size (Hedges' g) for between-group differences at 1-year follow-up was -0.41. CONCLUSION: Our behavioral activation program is simple and short. Nevertheless, the results obtained at 1-year follow-up of the control group and late adolescent students receiving treatment indicated a significant difference in their Beck Depression Inventory, second edition scores. Our 5-week behavioral activation program based on behavioral characteristics for subthreshold depression might be promising for subthreshold depression. The sample examined for this study imposed some study limitations.

Mechanisms of behavioral activation for late adolescents: Positive reinforcement mediate the relationship between activation and depressive symptoms from pre-treatment to post-treatment.

BACKGROUND: It is suggested that there is some support for notion that frequency of activity can lead to improved mood in behavioral activation, but this research is relatively imprecise. We investigated whether positive reinforcement mediates the relationship between activation and alleviation of depressive symptoms METHODS: Late adolescents with sub-threshold depressive symptoms participated in the study. We conducted an intervention using behavioral activation with the participants. Then, pre-and post-treatment results of behavioral activation were compared. We used mediation analysis using the bootstrapping method to examine whether changes in reinforcement mediated the relationship between changes in activation and improvements in depressive symptoms. RESULTS: Participants improved significantly at the post-intervention assessment, compared to the baseline assessment. Results of mediation analysis indicated that reinforcement significantly mediated the relationship between activation and depressive symptoms, whereas activation alone had no a direct effect on depressive symptoms. LIMITATIONS: Further studies with more diverse samples of participants are required in order to generalize the results of this study to more diverse populations. CONCLUSIONS: The study provides the first full mediational test of behavioral activation model including both measures of activation and positive reinforcement, and we found support for behavioral activation's presumed mechanism of action that contact with positive reinforcement mediates the relation between activity and depression.

Improved method of the MALDI-TOF analysis of DNA with nanodot sample target plate.

We report a new sample target plate for MALDI-TOF mass spectrometry made of SiO2 with 30 nm Pt dots for which a highly reproducible and improved DNA analysis was achieved.

[Creation and usefulness of the "drug information card" for support of dispensing].

We placed a "drug information card" on each medication shelf to assist dispensing by pharmacists, education of students, and risk management of pharmaceutical practices at the Department of Pharmacy, University of Tokyo Hospital. To provide appropriate information items on the drug information cards, we conducted questionnaire survey of 41 pharmacists on the utility of the cards and reviewed questions received from medical staff in the drug information section in our hospital. Based on the results of these investigations, "usage and dosage," "interactions," "contraindications," "product name," and "effects" were printed as basic information items on the drug information cards. Furthermore, information on pharmacokinetics was added. To make maintenance easier, we classified drug information items into "renew often" and "not so often." A good response on the use of the drug information cards was received for dispensing support from 38 pharmacists (92.7%), 14 trainees (100%), and 16 students (94.1%) in the questionnaire investigation. The drug information cards make it possible to obtain precise information rapidly in pharmacies.

Effectiveness of group cognitive-behavioral therapy in reducing self-stigma in Japanese psychiatric patients.

OBJECTIVE: There is evidence that the stigma surrounding mental illness may be greater in Japan than elsewhere. However, few Japanese studies have focused on self-stigma (the internalization of social stigma), and few interventions to reduce self-stigma exist. To remedy this deficiency, we evaluated the efficacy of group cognitive-behavioral therapy (CBT) in reducing self-stigma and examined the relationship between cognitive restructuring and self-stigma. METHODS: We administered a 10-session group CBT program to 46 Japanese outpatients with anxiety and depressive symptoms (36 men, 10 women; mean age=38.57 years, SD=8.33; 20 diagnosed with mood disorders; 24 with neurotic, stress-related, or somatoform disorders; and 2 with other disorders). A pretest-posttest design was used to examine the relationship between cognitive restructuring and self-stigma. Outcomes were measured using the Japanese versions of the Devaluation-Discrimination Scale, Dysfunctional Attitude Scale, Beck Depression Inventory-II, State-Trait Anxiety Inventory State-Form, and Rosenberg's Self Esteem Scale. RESULTS: Participants exhibited significant improvements in depression, anxiety, and maladjusted cognitive bias and reductions in self-stigma. Cognitive bias was significantly correlated with self-stigma. CONCLUSIONS: Group CBT is effective in improving both emotional symptoms and self-stigma in outpatients with anxiety and depressive symptoms. Reduction in self-stigma plays a mediating role in alleviating emotional symptoms and improving cognition.