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.

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: 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: Cognitive behavioral interventions delivered via the internet are demonstrably efficacious treatment options for posttraumatic stress disorder (PTSD) in underserved, Arabic-speaking populations. However, the role of specific treatment components remains unclear, particularly in conflict-affected areas of the Middle East and North Africa.
OBJECTIVE: This study aims to evaluate 2 brief internet-based treatments in terms of efficacy, including change in PTSD symptom severity during treatment. Both treatments were developed in line with Interapy, an internet-based, therapist-assisted cognitive behavioral therapy protocol for PTSD and adapted to the specific research question. The first treatment comprised self-confrontation and social sharing (exposure treatment; 6 sessions); the second comprised cognitive restructuring and social sharing (cognitive restructuring treatment; 6 sessions). The 2 treatments were compared with each other and with a waitlist control group.
METHODS: In total, 365 Arabic-speaking participants from the Middle East and North Africa (mean age 25.49, SD 6.68 y) with PTSD were allocated to cognitive restructuring treatment (n=118, 32.3%), exposure treatment (n=122, 33.4%), or a waitlist control group (n=125, 34.2%) between February 2021 and December 2022. PTSD symptom severity, posttraumatic maladaptive cognitions, anxiety, depressive and somatoform symptom severity, and quality of life were assessed via self-report at baseline and after treatment or waiting time. PTSD symptom severity was also measured throughout treatment or waiting time. Treatment satisfaction was assessed after treatment completion. Treatment use and satisfaction were compared between the 2 treatment conditions using appropriate statistical tests (eg, chi-square and Welch tests). Multiple imputation was performed to address missing data and evaluate treatment-associated changes. These changes were analyzed using multigroup change modeling in the completer and intention-to-treat samples.
RESULTS: Overall, 200 (N=240, 83.3%) participants started any of the treatments, of whom 123 (61.5%) completed the treatment. Treatment condition was not significantly associated with the proportion of participants who started versus did not start treatment (P=.20) or with treatment completion versus treatment dropout (P=.71). High treatment satisfaction was reported, with no significant differences between the treatment conditions (P=.48). In both treatment conditions, PTSD, anxiety, depressive and somatoform symptom severity, and posttraumatic maladaptive cognitions decreased, and quality of life improved significantly from baseline to the posttreatment time point (P≤.001 in all cases). Compared with the baseline assessment, overall PTSD symptom severity decreased significantly after 4 sessions in both treatment conditions (P<.001). Moreover, both treatment conditions were significantly superior to the waitlist control group regarding overall PTSD symptom severity (P<.001) and most other comorbid mental health symptoms (P<.001 to P=.03). Differences between the 2 conditions in the magnitude of change for all outcome measures were nonsignificant.
CONCLUSIONS: Internet-based cognitive behavioral treatments for PTSD focusing primarily on either self-confrontation or cognitive restructuring are applicable and efficacious for Arabic-speaking participants.
BACKGROUND: German Clinical Trials Register DRKS00010245; https://drks.de/search/de/trial/DRKS00010245.

UNASSIGNED: Depression in people with diabetes is associated with poorer health outcomes. Although web programs integrating cognitive-behavioral therapy with diabetes education have shown good results, no similar approach has been implemented in Spain. This aim of this study was to administer an Internet-based cognitive-behavioral therapy program (CBT) for the treatment of mild-moderate depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study) and evaluate the efficacy of this program.
UNASSIGNED: A pre-post randomized controlled study was conducted. The sample comprised 65 people with type 1 diabetes and mild-moderate depressive symptoms: 35 treatment group (TG) and 30 control group (CG). The following effects of the nine-session program were analyzed: depression (Beck Depression Inventory Fast Screen, BDI-FS), metabolic variables (glycosilated hemoglobin, HbA1c), and other psychological variables including anxiety (State Trait Anxiety Inventory, STAI), fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FH-15), distress (Diabetes Distress Questionnaire (DDS), quality of life (Diabetes Quality of Life Questionnaire, DQOL),and treatment adherence (Diabetes Self-Care Inventory-Revised questionnaire, SCI-R).
UNASSIGNED: At the end of the treatment program, only 28 people were evaluated (TG=8; CG=20). However, a significant reduction was found in both groups in BDI-FS and STAI-T scores, which was significantly greater in the TG. Significant improvements were also found in the TG in DQOL, FH-15, DDS and SCI-R scores. The percentage change in these variables was also statistically significant in the TG versus the CG. However, no significant results were found in HbA1c.
UNASSIGNED: The Internet-based cognitive-behavioral therapy program for the treatment of mild-moderate depressive symptomatology in people with type 1 diabetes (WEB_TDDI1 study) is effective in reducing depressive symptomatology in the sample that completed the study. Positive results are also produced in other variables associated with depression in this population such as diabetes-related distress, trait anxiety, fear of hypoglycemia, quality of life, and adherence to diabetes treatment. Although new studies would be necessary to support the results of this platform, the results obtained are positive and support the use of this platform as an appropriate treatment for this population.
UNASSIGNED: ClinicalTrials.gov; identifier NCT03473704.

•One of the first trials examining the efficacy of a brief preventive recovery training program in a sample of distressed employees.•Preliminary results suggest that employees across a wide range of professions could learn to recover, reduce stress, and improve quality-of-life.•This type of accessible and brief recovery intervention might shape the future of workplace stress prevention, however, more research is needed.
UNASSIGNED: This randomized, controlled pilot trial evaluated the efficacy of a brief internet-based recovery training intervention targeting a clinical sample of distressed employees.
UNASSIGNED: A sample of 69 employees with elevated symptoms of stress were assigned randomly to a five-week guided recovery training intervention (iRTP, n = 35) or a wait-list control (WLC, n = 34). The study was conducted in Sweden and participants enrolled via an open recruitment strategy. Self-report data were collected pre- and post-intervention, then six and 12 months after the intervention. The primary outcome measure was the Recovery Experience Questionnaire (REQ. The secondary outcome measures gauged other relevant mental and work-related health outcomes. Participants in the wait-list control group received access to iRTP after the six-month follow-up.
UNASSIGNED: Compared with the controls, participants in the intervention group showed a significant and large overall improvement on the primary outcome REQ (d = 0.93), and small to moderate effects on the secondary outcomes including, perceived stress (d = 0.48), anxiety (d = 0.49), quality of life (d = 0.47), and work ability (d = 0.47) during post-assessment. No significant differences were found at any time point regarding burnout, exhaustion, depression, physical exercise, work experience, or sickness absences.
UNASSIGNED: This pilot trial is one of the first to examine a brief recovery training program\'s efficacy, suggesting that employees across a wide range of professions could learn how to recover from elevated stress symptoms. This type of accessible and brief recovery intervention could potentially prevent and reduce the negative effects of stress, as well as improve recovery and quality of life. However, more research is needed with larger samples before further conclusions can be drawn.
UNASSIGNED: The study was registered at Clinical Trials (clinicaltrials.gov) number NCT05220592.