UNASSIGNED: Owing to a lack of social support, child-rearing Chinese women in Japan experience mental health disorders, such as depression and parenting stress. Effective interventions to improve the mental health of these women are lacking. This study aimed to develop an Internet-based mental health promotion intervention for this subsection of the population and evaluate the effectiveness of the intervention.
UNASSIGNED: We used a quasi-experimental pre- and post-test design whereby the results of the intervention group were compared with those of a control group. Seventy-three child-rearing women were recruited from online groups of Chinese residents in Japan. In the Internet-based intervention, participants utilised an information provision application and attended online parenting workshops. The intervention group participated in the online workshops once a week for six weeks and accessed the application, whereas the control group did not. The outcome measures included the levels of mental health distress, depression, social support, and parenting stress. Data were collected from February to April 2022. Data analysis was performed using repeated-measures analysis of variance.
UNASSIGNED: Mental health distress (F = 16.478, p < 0.001, η2 = 0.210) and depression (F = 13.078, p = 0.001, η2 = 0.174) were significantly affected in the intervention group compared with the control group. There were no significant differences in social support and parenting stress between the groups. The Internet-based mental health promotion intervention was highly appraised by the participants.
UNASSIGNED: This study developed an Internet-based mental health promotion intervention that involved an information provision application and parenting workshops. The intervention significantly reduced the mental health distress and depression of Chinese women in Japan but did not affect social support and parenting stress. The findings suggest that this intervention could be applied to foreign women with multicultural backgrounds in diverse settings to improve their psychological well-being.

BACKGROUND: Genetic testing is essential to identify research participants for clinical trials enrolling people with Parkinson disease (PD) carrying a variant in the glucocerebrosidase (GBA) or leucine-rich repeat kinase 2 (LRRK2) genes. The limited availability of professionals trained in neurogenetics or genetic counseling is a major barrier to increased testing. Telehealth solutions to increase access to genetics education can help address issues around counselor availability and offer options to patients and family members.
OBJECTIVE: As an alternative to pretest genetic counseling, we developed a web-based genetics education tool focused on GBA and LRRK2 testing for PD called the Interactive Multimedia Approach to Genetic Counseling to Inform and Educate in Parkinson\'s Disease (IMAGINE-PD) and conducted user testing and usability testing. The objective was to conduct user and usability testing to obtain stakeholder feedback to improve IMAGINE-PD.
METHODS: Genetic counselors and PD and neurogenetics subject matter experts developed content for IMAGINE-PD specifically focused on GBA and LRRK2 genetic testing. Structured interviews were conducted with 11 movement disorder specialists and 13 patients with PD to evaluate the content of IMAGINE-PD in user testing and with 12 patients with PD to evaluate the usability of a high-fidelity prototype according to the US Department of Health and Human Services Research-Based Web Design & Usability Guidelines. Qualitative data analysis informed changes to create a final version of IMAGINE-PD.
RESULTS: Qualitative data were reviewed by 3 evaluators. Themes were identified from feedback data of movement disorder specialists and patients with PD in user testing in 3 areas: content such as the topics covered, function such as website navigation, and appearance such as pictures and colors. Similarly, qualitative analysis of usability testing feedback identified additional themes in these 3 areas. Key points of feedback were determined by consensus among reviewers considering the importance of the comment and the frequency of similar comments. Refinements were made to IMAGINE-PD based on consensus recommendations by evaluators within each theme at both user testing and usability testing phases to create a final version of IMAGINE-PD.
CONCLUSIONS: User testing for content review and usability testing have informed refinements to IMAGINE-PD to develop this focused, genetics education tool for GBA and LRRK2 testing. Comparison of this stakeholder-informed intervention to standard telegenetic counseling approaches is ongoing.

OBJECTIVE: Persistent physical symptoms (PPS) represent a major health problem affecting daily functioning. This RCT aimed to examine whether a guided Internet-based treatment based on acceptance and commitment therapy (ACT) provided additional benefits compared to Treatment as Usual (TAU) in reducing somatic complaints and psychological distress in adults with PPS.
METHODS: A total of 103 adults with PPS related to indoor environments, chronic fatigue or both conditions were assigned to receive either either a 14-week intervention (video-based case conceptualization + Internet-based ACT) combined with TAU (iACT + TAU; n = 50) or TAU alone (n = 53). Somatic symptoms, depression, anxiety, insomnia, and psychological flexibility were assessed from pre-intervention to a 3-month follow-up. Additionally, the association between changes in psychological flexibility from pre- to post-intervention and changes in symptoms from pre to 3-month follow-up was explored. Analyses were conducted using a multigroup method with full information maximum likelihood estimator.
RESULTS: The results revealed a significant interaction effect, indicating reductions in somatic symptoms and symptoms of depression and anxiety with moderate to large between-group effects (d = 0.71-1.09). No significant interaction effect was observed in insomnia and measures of psychological flexibility.
CONCLUSIONS: Internet-based ACT, when combined with Treatment as Usual, demonstrated efficacy for individuals with PPS associated with indoor environments and chronic fatigue. These findings are pertinent for primary healthcare providers, suggesting that the current treatment model could serve as a low-threshold first-line treatment option.
BACKGROUND: NCT04532827.

OBJECTIVE: Limited evidence on home care and need for long-term individualized follow-up highlight the importance of developing an Internet-based follow-up platform to support caregivers of children with Bronchiolitis Obliterans (BO). This Study aims to explore and test the potential benefits of this platform by comparing family management, medication compliance and clinical systems.
METHODS: A two-arm, single-blind randomized controlled trial was conducted on 168 children with BO and their families from January 2022 to October 2022. Families were randomly divided into Internet-based follow-up group and conventional follow-up group with a ratio of 1:1. Scores of family management measures (FaMM), 8-item of Morisky Medication Adherence (8-MMAS) and BO clinical symptoms of both groups were collected at three points of time: the day of discharge (T1), 3 months after discharge (T2), and 6 months after discharge (T3). The changes of each group due to intervention were compared by repeated-measures ANOVA.
RESULTS: 90 families completed the trial, including 48 in the Internet-based follow-up group and 42 in the conventional follow-up group. The results showed a significant difference in the group-by-time interaction on the scores of Child\'s Daily Life, Condition Management Ability and Parental Mutuality (p < 0.05). No group-by-time effect was found on the scores of View of Condition Impact and Family Life Difficulty. Scores of BO clinical symptoms and MMAS-8 showed intra-group, inter-group, and group-by-time effects.
CONCLUSIONS: The Internet-based follow-up platform can empower caregivers in enhancing effective family management, improving medication compliance in children with BO, and relieving patients\' clinical symptoms.
BACKGROUND: Chinese Clinical Trials Registry of ChiCTR2200065121 (04/28/2022).

UNASSIGNED: Non-suicidal self-injury (NSSI) behaviors of adolescents with affective disorders can directly deteriorate parents\' internal experiences, and negative parental experiences can exacerbate or even worsen NSSI behaviors. This study investigates the impact of NSSI behaviors exhibited by adolescents with affective disorders on the internal experiences of parents. Specifically, our research focuses on the inner experiences of parents when their children engage in NSSI behaviors during social isolation of the COVID-19, offering insights for addressing parental mental health issues related to NSSI and developing positive parental behavioral models to optimize adolescent behavior during major public health events.
UNASSIGNED: Semi-structured interviews were conducted with 21 parents of adolescents with affective disorders displaying NSSI behaviors during the COVID-19 pandemic. The Colaizzi 7-step analysis was employed to refine and categorize emerging themes.
UNASSIGNED: Our study revealed that parents of adolescents facing NSSI during the COVID-19 pandemic underwent different internal experiences, which could be classified into four themes: negative experience, high caregiving burden, lack of caregiving capacity, and resilience.
UNASSIGNED: This Internet-based research is the first to explore the internal experiences of parents of adolescents with affective disorders experiencing NSSI during the COVID-19 pandemic. It sheds light on how parents, in response to their children\'s NSSI behaviors, undergo resilience following negative experiences, explore more open and supportive family model. Despite these positive outcomes, parents express a need for increased knowledge about NSSI illness care and a desire for professional assistance.

BACKGROUND: Effective emotional regulation (ER) skills are important for sexual function, as they impact emotional awareness and expression during sexual activity, and therefore, satisfaction and distress. Emotion regulation interventions may offer a promising approach to improve sexual health. Web-based emotion regulation may be a therapeutic strategy for men and women with sexual health concerns. Nevertheless, there is a scarcity of intervention trials investigating its effects in this context, much less using the internet.
OBJECTIVE: This study aims to investigate the effects of a web-based emotion regulation training program for sexual function in both men and women.
METHODS: The participants were recruited based on their self-reported sexual problems, which for men was defined by a score of <25 on the International Index Erectile Function (IIEF) and for women by a score of <26.55 on the Female Sexual Function Index (FSFI). The final sample included 60 participants who were randomized to either a web-based emotion regulation training for sexual function or to a waitlist control group. The treatment consisted of an 8-week web-based emotion regulation training for sexual function. The participants were assessed at baseline, post intervention, and the 3-month follow-up.
RESULTS: Of the 60 participants included, only 6 completed all 3 assessment points (n=5, 20% in the treatment group and n=1, 5% in the waitlist control group) after receiving the intervention. At follow-up, there were no significant differences between groups in any measure. Among the intervention completers, large-to-moderate within-group effect sizes were observed between the assessment points on measures of emotion regulation, depression, lubrication, orgasm, thoughts of sexual failure, and abuse during sexual activity. The adherence rate was very low, limiting the generalizability of the findings.
CONCLUSIONS: Participants who completed the intervention showed improvements in both sexual function domains and emotion regulation. Nonetheless, due to a high dropout rate, this trial failed to collect sufficient data to allow for any conclusions to be drawn on treatment effects.
BACKGROUND: ClinicalTrials.gov NCT04792177; https://clinicaltrials.gov/study/NCT04792177.

Background: A Zoom-based website was developed in 2020 that offers continuous access to online Narcotics Anonymous (NA) meetings for the first time. This website provides immediate access for persons with substance use disorder to support abstinence from substance-related addictive disorders.Objectives: This study is designed to characterize attendees employing this online format; to evaluate their experiences for gaining support to maintain abstinence; and to compare the 24/7 experience to face-to-face (FF) meetings they attend.Methods: An anonymous 33-item survey was made available on the 24/7 NA website that links to the 24/7 meetings. Persons accessing the site could choose to fill out the survey.Results: 530 respondents completed the survey (64.9% female/35.1% male). Most had stable prior involvement in NA. They had attended more 24/7 meetings (14.9, SD 19.7) than FF meetings (4.6, SD 7.8) in the previous month. 86% had previously attended FF meetings, 48% had served as sponsors, and 92% reported that the 24/7 meetings were more comfortable for them than the FF meetings (p < .001, Cohen\'s d = 0.65) and more supportive of abstinence (p < .001, Cohen\'s d = 0.91). Of the respondents, 8% were still using drugs, of whom 52% had previously completed some of the Twelve Steps.Conclusions: The 24/7 format provides a new and easily accessible way for NA members to gain support for abstinence and is positively rated by attendees seeking support for recovery from substance use disorders. It may serve as a valuable adjunct to the traditional FF format.

BACKGROUND: Cytotoxic treatments such as chemo- and radiotherapy and immune therapies are required in cancer diseases. These therapies have the potential to cure patients but may also have an impact on gonadal function and, therefore, on fertility. Consequently, fertility preservation treatments such as freezing of gametes and gonadal tissue might be required. However, as detailed data about the necessity to perform fertility preservation treatment are very limited, this study was designed to fill this data gap.
OBJECTIVE: Primary objective of this study is to analyze the impact of cancer therapies and chemotherapies on the ovarian reserve and sperm quality. Secondary objectives are to analyze the (1) impact of cancer therapies and chemotherapies on other fertility parameters and (2) probability of undergoing fertility preservation treatments in relation to specific cancer diseases and treatment protocols and the probability to use the frozen gametes and gonadal tissue to achieve pregnancies.
METHODS: First, previously published studies on the gonadotoxicity of chemo- and radiotherapies among patients with cancer will be systematically analyzed. Second, a prospective cohort study set up by approximately 70 centers in Germany, Switzerland, and Austria will collect the following data: ovarian function by analyzing anti-Müllerian hormone (AMH) concentrations and testicular function by analyzing sperm parameters and total testosterone immediately before and around 1 year after gonadotoxic therapies (short-term fertility). A follow-up of these fertility parameters, including history of conceptions, will be performed 5 and 10 years after gonadotoxic therapies (long-term fertility). Additionally, the proportion of patients undergoing fertility-preserving procedures, their satisfaction with these procedures, and the amount of gametes and gonadal tissue and the children achieved by using the frozen material will be analyzed. Third, the data will be merged to create the internet-based data platform FertiTOX. The platform will be structured in accordance with the ICD (International Classification of Diseases) classification of cancer diseases and will be easily be accessible using a specific App.
RESULTS: Several funding bodies have funded this study. Ten systematic reviews are in progress and the first one has been accepted for publication. All Swiss and many German and Austrian ethics committees have provided their approval for the prospective cohort study. The study registry has been set up, and a study website has been created. In total, 50 infertility centers have already been prepared for data collection, which started on December 1, 2023.
CONCLUSIONS: The study can be expected to bridge the data gap regarding the gonadotoxicity of cancer therapies to better counsel patients about their infertility risk and their need to undergo fertility preservation procedures. Initial data are expected to be uploaded on the FertiTOX platform in 2026.
BACKGROUND: ClinicalTrials.gov NCT05885048; https://clinicaltrials.gov/study/NCT05885048.
UNASSIGNED: DERR1-10.2196/51145.

BACKGROUND: Cognitive behavioral therapy (CBT) is effective in treating anxiety disorders. Accessibility to CBT has been limited in Japan due to the shortage of therapists. While an open-source e-learning system can be used to create a simple internet-based cognitive behavioral therapy (ICBT) program, the safety and outpatient acceptance of this treatment approach have not been explored in Japan.
OBJECTIVE: The aim of this study was to investigate whether outpatients with anxiety disorders could accept and successfully complete the ICBT program with guidance by CBT therapists when implementing therapeutic modules and CBT tasks. Due to being in the initial phase of a novel treatment in Japan, this study was intended for verification with a small sample size.
METHODS: In total, 6 adults, including 4 male participants and 2 female participants, were enrolled in a single-arm trial. The intervention involved guided ICBT comprising 12 sessions, including CBT text, comprehension confirmation tests, and explanatory videos about cognitive behavioral models, accessible through a website. The therapist guided the participants in accessing the ICBT program and answering their questions using a chat tool. The primary outcome was anxiety severity assessed using the State-Trait Anxiety Inventory-Trait. Secondary outcomes included the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale (LSAS), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Working Alliance Inventory-Short Form (WAI-SF). Statistical analyses were performed using paired 2-tailed t tests to assess the changes in clinical symptoms. The total WAI-SF score at the final session was used to evaluate the therapeutic alliance. For statistical analyses, mean changes for total State-Trait Anxiety Inventory-Trait, BAI, Panic Disorder Severity Scale, LSAS, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7 scores were analyzed using the paired 2-tailed t test. The 2-sided significance level for hypothesis testing was set at 5%, and 2-sided 95% CIs were calculated.
RESULTS: Most participants diligently engaged with the ICBT program. No adverse events were reported. The mean total scores for the primary outcome decreased by 11.0 (SD 9.6) points (95% CI -22.2 to 0.20; Hedges g=0.95), but it was not statistically significant. The mean total scores for the secondary outcomes that assess clinical symptoms decreased, with a significant reduction observed in the BAI of 15.7 (SD 12.1) points (95% CI -28.4 to -3.0; P=.03; Hedges g=1.24). The mean total scores for PDSS and LSAS decreased significantly, by 12.0 (SD 4.24) points (95% CI -50.1 to 26.1; P=.16; Hedges g=1.79) and 32.4 (SD 11.1) points (95% CI -59.7 to -4.3; P=.04; Hedges g=1.38), respectively. Of the participants, 67% (n=4) showed treatment response, and 50% (n=3) achieved remission after the intervention. The therapeutic alliance, measured using the WAI-SF, was moderate.
CONCLUSIONS: Guided ICBT may be feasible for the treatment of outpatients with panic disorder and social anxiety disorder in Japan.
BACKGROUND: University Hospital Medical Information Network Clinical Trials Registry UMIN0000038118; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439.

BACKGROUND: There is a growing interest in developing scalable interventions, including internet-based cognitive behavioral therapy (iCBT), to meet the increasing demand for mental health services. Given the growth in diversity worldwide, it is essential that the clinical trials of iCBT for depression include diverse samples or, at least, report information on the race, ethnicity, or other background indicators of their samples. Unfortunately, the field lacks data on how well diversity is currently reported and represented in the iCBT literature.
OBJECTIVE: Thus, the main objective of this systematic review was to examine the overall reporting of racial and ethnic identities in published clinical trials of iCBT for depression. We also aimed to review the representation of specific racial and ethnic minoritized groups and the inclusion of alternative background indicators such as migration status or country of residence.
METHODS: Studies were included if they were randomized controlled trials in which iCBT was compared to a waiting list, care-as-usual, active control, or another iCBT. The included papers also had to have a focus on acute treatment (eg, 4 weeks to 6 months) of depression, be delivered via the internet on a website or a smartphone app and use guided or unguided self-help. Studies were initially identified from the METAPSY database (n=59) and then extended to include papers up to 2022, with papers retrieved from Embase, PubMed, PsycINFO, and Cochrane (n=3). Risk of bias assessment suggested that reported studies had at least some risk of bias due to use of self-report outcome measures.
RESULTS: A total of 62 iCBT randomized controlled trials representing 17,210 participants are summarized in this study. Out of those 62 papers, only 17 (27%) of the trials reported race, and only 12 (19%) reported ethnicity. Reporting outside of the United States was very poor, with the United States accounting for 15 (88%) out of 17 of studies that reported race and 9 (75%) out of 12 for ethnicity. Out of 3,623 participants whose race was reported in the systematic review, the racial category reported the most was White (n=2716, 74.9%), followed by Asian (n=209, 5.8%) and Black (n=274, 7.6%). Furthermore, only 25 (54%) out of the 46 papers conducted outside of the United States reported other background demographics.
CONCLUSIONS: It is important to note that the underreporting observed in this study does not necessarily indicate an underrepresentation in the actual study population. However, these findings highlight the poor reporting of race and ethnicity in iCBT trials for depression found in the literature. This lack of diversity reporting may have significant implications for the scalability of these interventions.