Efficacy of an online gatekeeper program for relatives of men at risk of suicide - a randomized controlled trial.

BACKGROUND: Men at risk for suicide are a challenging population group to reach with suicide prevention strategies. Gatekeepers hold a pivotal role in the prevention of male suicide, yet effective intervention requires them to have a level of knowledge and strategies to provide support. AIM: This study aimed to examine the efficacy of an online gatekeeper program for gatekeepers in male suicide prevention, assessing knowledge, perceived preparedness, self-efficacy, and psychopathological symptoms of gatekeepers. METHODS: Eighty-four participants were randomized to either the intervention (n = 43) or the waitlist control group (n = 41). The intervention comprised four modules providing knowledge and strategies for addressing men in suicidal crises. Outcomes included depression (PHQ-9), distress (PSS-10), burden (BAS), involvement (IEQ), as well as gatekeeper outcomes and knowledge. RESULTS: Completer analyses revealed significant improvement of depressive symptoms (d = 0.39) and an increase in gatekeeper outcomes (d = 0.58 to d = 0.84) and knowledge (d = 0.62) from baseline to post-assessment. The effects were maintained for 3 months. No significant effects could be found for burden, distress, and involvement. CONCLUSIONS: The findings indicate that a brief gatekeeper program can serve as a valuable resource. Future research should focus on examining the mental health of gatekeepers themselves and its long-term effects on intervention behavior. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00030758, registered on 05.12.2022.

Internet-based UP-A intervention on treatment of stress, anxiety, depression, and psychological flexibility among adolescents with sub-clinical diagnosis of emotional disorders during the COVID-19 pandemic: a clinical trial.

This clinical trial aims to assess the effectiveness of internet-based Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) during the COVID-19 pandemic in reducing stress, anxiety, and depression, and psychological flexibility. 40 adolescents with subclinical features of emotional disorder randomly divided into two groups of intervention and control. The participants first completed DASS-21 and AAQ-2 questionnare online. Then, the intervention group received 12 sessions of UP-A through video calls on WhatsApp, 2 days per week each for 45 min. UP-A is an emotion-focused, cognitive-behavioral therapy consisting of 5 core modules or components that target temperamental characteristics, particularly neuroticism and resulting emotion dysregulation. Eventually the stress, anxiety, and depression levels decreased in intervention group and their psychological flexibility increased immediately and 3 months after the intervention. Clinical trial registration This study was registered by Iranian Registry of Clinical Trials (Prospective, ID: IRCT20210428051113N1, Registration date: 14/06/2021; https://en.irct.ir/trial/55900 ).

Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND: Early neurodevelopmental risks, compounded with traumatic medical experiences, contribute to emotional and behavioral challenges in as many as 1 in 2 children with congenital heart disease (CHD). Parents report a strong need for supports; yet, there remains a lack of accessible, evidence-based behavioral interventions available for children with CHD and their families. I-InTERACT-North is a web-based stepped-care mental health program designed to support family well-being and reduce behavioral concerns through positive parenting for children with early medical complexity. In previous pilot studies, the program was effective in increasing positive parenting skills and decreasing child behavior problems, with high parent-reported acceptability. This paper presents the protocol for the first randomized study of stepped-care parent support for families of children with CHD. OBJECTIVE: This study will involve a single-site, 2-arm, single-blind randomized controlled trial to evaluate (1) the feasibility and acceptability of a web-based stepped-care parent support program (I-InTERACT-North) and (2) the effectiveness of the program in enhancing positive parenting skills and reducing behavioral concerns among families of children with CHD. METHODS: Families will be randomized (1:1) to either receive treatment or continue with care as usual for 12 months. Randomization will be stratified by child's sex assigned at birth and baseline parent-reported child behavior intensity. Primary outcomes include positive parenting skills and child behavior at baseline, 3 months, 6 months, and 12 months. Secondary outcomes include parental mental health, quality of life, service usage, and feasibility including program reach and adherence. A sample size of 244 families will provide >95% power to detect an effect size of d=0.64. Based on attrition data from pilot studies, a target of 382 families will be enrolled. Parent reports of acceptability, adoption, and suggested adaptability of the program will be examined using cross-case thematic analyses. Primary efficacy analysis will be conducted using an intent-to-treat approach. Generalized estimating equations will be used to examine changes in positive parenting. Child behavior, quality of life, and parent mental health will be tested with repeated-measures analyses. Additional sensitivity and replication analyses will also be carried out. RESULTS: Recruitment began in February 2024, and recruitment and follow-up will continue until January 2029. We anticipate results in late 2029. CONCLUSIONS: This study aims to test the effectiveness of I-InTERACT-North web-based stepped-care parent support in improving positive parenting skills and reducing child behavior problems in families of children with CHD compared with a care as usual control group. Results will inform future clinical implementation and expansion of this program among families of children with early medical conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT06075251; https://clinicaltrials.gov/study/NCT06075251. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64216.

Internet-Based Supportive Interventions for Family Caregivers of People With Dementia: Randomized Controlled Trial.

Background: As dementia progresses, patients exhibit various psychological and behavioral symptoms, imposing a significant burden on families and society, including behavioral and psychological symptoms of dementia. However, caregivers lack professional care knowledge and skills, making it difficult for them to effectively cope with the diverse challenges of caregiving. Therefore, it is necessary to provide caregivers with professional knowledge and skills guidance. Objective: This study aimed to analyze the impact of internet-based training on behavioral and psychological symptoms of dementia in patients, and explore how this training model affects the caregiving abilities and caregiving burden of the family caregivers of patients with dementia. Methods: Using a consecutive enrollment method, the Department of Geriatrics at Zhejiang Hospital (Zhejiang, China) recruited 72 informal caregivers of patients with dementia. These caregivers were randomly divided into an intervention group and a control group, with 36 participants in each group. The intervention group underwent caregiver skill training via a web-based platform, whereas the control group initially received face-to-face follow-up guidance and was subsequently offered web-based training after 6 months. To assess the effectiveness of the intervention program, we used the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Chinese version of the Zarit Burden Interview (CZBI), and the Sense of Competence in Dementia Care Staff Scale (SCIDS) for evaluations conducted before the intervention, 3 months after the intervention, and 6 months after the intervention. Results: Between July 2019 and December 2020, a total of 66 patients successfully completed the intervention and follow-up. After 6 months of intervention, the NPI-Q score of the intervention group was 3.18 (SD 3.81), the CZBI score was 10.97 (SD 5.43), and the SCIDS score was 71.88 (SD 4.78). The NPI-Q score of the control group was 8.09 (SD 8.52), the CZBI score was 30.30 (SD 13.05), and the SCIDS score was 50.12 (SD 9.10). There were statistically significant differences in NPI-Q (P=.004), CZBI (P<.001), and SCIDS scores (P<.001) between the intervention group and the control group. Repeated measures analysis of variance showed that compared with before the intervention, there were statistically significant differences in CZBI (P<.001) and SCIDS (P<.001) scores 3 months after the intervention, while the difference in NPI-Q (P=.11) scores was not significant. The total scores of NPI-Q (P<.001), CZBI (P<.001), and SCIDS (P<.001) were significantly improved 6 months after the intervention. In addition, the results of the covariance analysis showed that after excluding the time effect, the web-based training intervention significantly reduced the NPI-Q score (-2.79, 95% CI -4.38 to -1.19; P<.001) of patients with dementia and the CZBI score (-13.52, 95% CI -15.87 to -11.16; P<.001) of caregivers, while increasing the SCIDS score (12.24, 95% CI 9.02-15.47; P<.001). Conclusions: Internet-based training could significantly reduce the level of behavioral symptoms in older patients with dementia and alleviate the burden on caregivers, enhancing their caregiving abilities. Our results confirmed the effectiveness and feasibility of web-based training, which was of great significance in providing caregiving knowledge training for informal caregivers of persons with dementia.

Reflections on Integrating a Therapist-guided CBT Website Into Routine Clinical Practice.

Psychotherapy remains a scarce resource for patients, as problems such as provider shortages result in waitlists and lack of timely access. In their academic medical center outpatient clinic, the coauthors piloted use of a therapist-guided CBT website, Good Days Ahead, in routine clinical practice. They reflect on the benefits and challenges of this approach in this guest column.

Effects of web-based interventions on quality of life among patients with breast cancer: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Patients with breast cancer experience decreased quality of life due to various physical and psychological challenges. Web-based interventions are accessible, cost-effective, and convenient for improving their quality of life. This study evaluated whether web-based interventions improve quality of life and included only randomized controlled trials (RCTs) with clear evidence. METHODS: PubMed, Embase, Cochrane Library, CINAHL, Web of Science, and PsycINFO were searched for articles published until October 16, 2023. Inclusion criteria were RCTs evaluating the effect of web-based interventions on quality of life in patients with breast cancer. The risk of bias was assessed with Cochrane's Risk of Bias Tool 2.0. Standardized mean differences were calculated with a random effects model using R version 4.0.3, and subgroup and moderator analyses were performed. RESULTS: Since quality of life was measured using two different instruments in two studies, 21 comparisons were analyzed from 19 RCTs. As a result, the findings suggest that web-based interventions have a small effect size on improving the quality of life for patients with breast cancer (SMD = 0.27, 95% confidence intervals [CIs]: 0.15-0.38, p = 0.03). Heterogeneity was found to be low (I2 = 40%). The quality-of-life subdomain results showed a moderate effect size on the physical functioning and a small effect size on the cognitive and emotional functioning of patients with breast cancer but no significant impact on their role or social functioning. CONCLUSIONS: Web-based interventions are effective in improving patients' quality of life with breast cancer; they also improve physical, cognitive, and emotional functioning. However, evidence regarding intervention methods remains inconclusive due to the limited number of RCTs, necessitating further research.

Feasibility and acceptability pilot study of an online weight loss program in rural, underserved communities.

Background: The purpose of this intervention was to investigate the feasibility, acceptability, and preliminary effectiveness of an online weight loss program, EMPOWER, in rural, underserved communities. Methods: Adults with a body mass index (BMI) ≥ 25 kg/m2 living in rural counties were recruited through collaboration with University of Illinois Extension. The intervention lasted 1 year including online educations sessions, nutrition and lifestyle coaching, and diet and weight monitoring via a novel web application, MealPlot. Feasibility was measured by enrollment attainment, participant retention, online education session completion, and completion of anthropometric and dietary measures. Acceptability was measured by survey using Likert scales of satisfaction for all program components. Anthropometric measurements, 24-h dietary records, and food frequency questionnaires (FFQs) were measures of program efficacy. Additionally, two interviews were collected for program feedback. Results: Enrollment of 16 participants was attained, however due to higher than anticipated dropout (retention 62.5%, N = 10) at 3-months, 62.5% of the education sessions were completed and 75.0% of anthropometric and dietary measures. The average satisfaction rating for the comprehensive program was 4.2/5 with lowest satisfaction being the MealPlot web application 2.7/5 (N = 11). On average a clinically significant (≥5% baseline weight) weight loss of 6.2 ± 6.0% body weight or 5.7 ± 5.3 kg and improvements to protein and fiber intake at 12 months (N = 10) were observed. Conclusions: A novel online weight loss program showed adequate to strong feasibility and acceptability and preliminary results indicating efficacy among a pilot sample of rural residents. Future studies are required to investigate means of improving retention and reducing the burden on program collaborators.

Effectiveness of an interactive online group intervention based on pain neuroscience education and graded exposure to movement in breast cancer survivors with chronic pain: a randomised controlled trial.

PURPOSE: To evaluate the effectiveness, compared with usual care, of an interactive online group programme combining pain neuroscience education (PNE) and graded exposure to movement (GEM) for improving quality of life and pain experience in breast cancer survivors with chronic pain. METHODS: This single-blind randomised controlled trial included a sample of 49 breast cancer survivors who were randomly assigned to two groups (experimental: n = 22 and control: n = 27). The experimental group received a 12-week person-centred online programme based on pain neuroscience education and therapeutic yoga as gradual exposure to movement, while the control group continued with their usual care. The primary outcome was quality of life (FACT-B + 4); the secondary outcomes were related to the experience of chronic pain (pain intensity, pain interference, catastrophizing, pain self-efficacy, kinesiophobia, and fear avoidance behaviours). All variables were assessed at four time points (T0, baseline; T1, after PNE sessions; T2, after yoga sessions; T3, at 3-month follow-up). For data analysis, ANOVA (2 × 4) analysis of variance (95% CI) was used when outcomes were normally distributed. If not, within-group and between-group comparisons were calculated. RESULTS: Thirty-six participants were included in the analysis (control group, 22; experimental group, 14). A significant time * group effect was observed in favour of the experimental group regarding the global quality of life score (p = 0.010, ηp2 = 0.124). Significant differences in favour of the experimental group were observed for pain intensity, pain interference, catastrophizing, and pain self-efficacy. These differences persisted at follow-up. CONCLUSIONS: An online intervention based on PNE and GEM appears to be more effective than usual care for improving quality of life in breast cancer survivors with chronic pain, as a time per group interaction was reported. In addition, the intervention also significantly improved the participants' experience of chronic pain. However, due to the study limitations further research is needed. Trial record: NCT04965909 (26/06/2021).

A hybrid type II effectiveness-implementation trial of a positive emotion regulation intervention among people living with HIV engaged in Ryan White Medical Case Management: protocol and design for the ORCHID study.

BACKGROUND: The Ryan White Medical Case Management System, which serves more than half of people living with HIV (PLWH) in the USA, is an opportune setting for identifying and addressing depression among PLWH. A growing body of research suggests that interventions that promote positive emotion may lessen symptoms of depression and improve physical and psychological well-being among people experiencing a variety of health-related stress, including living with HIV. Research on how best to integrate standardized mental health screening and referral to evidence-based interventions in Ryan White Medical Case Management settings has the potential to improve the health and wellbeing of PLWH. METHODS: This mixed-methods study will enroll up to N = 300 Ryan White clients who screen positive for depressive symptoms in ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a web-based, self-guided positive emotion regulation intervention. The study will be conducted in 16 Ryan White Medical Case Management clinics in Chicago, IL. Following pre-implementation surveys and interviews with Medical Case Managers (MCMs) and Supervisors to develop an implementation facilitation strategy, we will conduct a hybrid type 2 implementation-effectiveness stepped wedge cluster randomized trial to iteratively improve the screening and referral process via interviews with MCMs in each wedge. We will test the effectiveness of ORCHID on depression and HIV care outcomes for PLWH enrolled in the program. RE-AIM is the implementation outcomes framework and the Consolidated Framework for Implementation Research is the implementation determinants framework. DISCUSSION: Study findings have the potential to improve mental health and substance use screening of Ryan White clients, decrease depression and improve HIV care outcomes, and inform the implementation of other evidence-based interventions in the Ryan White Medical Case Management System. TRIAL REGISTRATION: ClinicalTrials.gov NCT05123144. Trial registered 6/24/2021.

Efficacy of an internet-based guided trauma-focused intervention in reducing ICD-11 posttraumatic stress disorder symptoms: study protocol of a randomized controlled trial.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a common mental disorder. However, many cases of PTSD remain untreated because of limited healthcare resources and other treatment-seeking barriers. Effective internet-based interventions could help to improve access to PTSD treatments. Therefore, the main objective of the planned randomized controlled trial is to evaluate the efficacy of the Lithuanian version of the guided internet-based self-help programme (Spring) in reducing ICD-11 PTSD symptoms. METHODS: The planned sample size is 50 participants exposed to different traumatic experiences. Participants eligible for the study will be randomized into two study groups: the immediate treatment group and the delayed treatment control group. Both groups will receive guided trauma-focused ICBT intervention, but the delayed treatment group will receive access to the programme five months after randomization. The International Trauma Interview (ITI) will be used for the assessment of ICD-11 PTSD symptoms at pre-treatment, post-treatment, and at a 3-month follow-up. Changes in disturbances in self-organization, depression and anxiety levels, as well as posttraumatic cognitions and trauma-related shame, will also be evaluated. In addition, associations between changes in symptoms of PTSD and readiness for treatment, treatment expectations and working alliance will be explored. Changes in treatment outcomes will be evaluated using multiple Latent Change Models. DISCUSSION: This study is expected to contribute to valuable knowledge on the efficacy of internet-based interventions for posttraumatic stress disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT06475716. Registered on 25 June 2024.

Long-Term Effects of Internet-Based Cognitive Behavioral Therapy on Depression Prevention Among University Students: Randomized Controlled Factorial Trial.

Background: Internet-based cognitive behavioral therapy (iCBT) shows promise in the prevention of depression. However, the specific iCBT components that contribute to its effectiveness remain unclear. Objective: We aim to evaluate the effects of iCBT components in preventing depression among university students. Methods: Using a smartphone cognitive behavioral therapy (CBT) app, we randomly allocated university students to the presence or absence of 5 different iCBT components: self-monitoring, behavioral activation, cognitive restructuring, assertiveness training, and problem-solving. The active intervention lasted 8 weeks but the app remained accessible through the follow-up. The primary outcome was the onset of a major depressive episode (MDE) between baseline and the follow-up after 52 weeks, as assessed with the computerized World Health Organization Composite International Diagnostic Interview. Secondary outcomes included changes in the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, and CBT Skills Scale. Results: During the 12-month follow-up, 133 of 1301 (10.22%) participants reported the onset of an MDE. There were no significant differences in the incidence of MDEs between the groups with or without each component (hazard ratios ranged from 0.85, 95% CI 0.60-1.20, for assertiveness training to 1.26, 95% CI 0.88-1.79, for self-monitoring). Furthermore, there were no significant differences in the changes on the 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder, or for CBT Skills Scale between component allocation groups. However, significant reductions in depression and anxiety symptoms were observed among all participants at the 52-week follow-up. Conclusions: In this study, we could not identify any specific iCBT components that were effective in preventing depression or the acquisition of CBT skills over the 12-month follow-up period, but all participants with and without intervention of each iCBT component demonstrated significant improvements in depressive and anxiety symptoms. Further research is needed to explore the potential impact of frequency of psychological assessments, nonspecific intervention effects, natural change in the mental state, and the baseline depression level.

Breaking Down Barriers to a Suicide Prevention Helpline: Web-Based Randomized Controlled Trial.

Background: Every month, around 3800 people complete an anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline. Although 70% score high on the severity of suicidal thoughts, <10% navigate to the web page about contacting the helpline. Objective: This study aimed to test the effectiveness of a brief barrier reduction intervention (BRI) in motivating people with severe suicidal thoughts to contact the suicide prevention helpline, specifically in high-risk groups such as men and middle-aged people. Methods: We conducted a fully automated, web-based, randomized controlled trial. Respondents with severe suicidal thoughts and little motivation to contact the helpline were randomly allocated either to a brief BRI, in which they received a short, tailored message based on their self-reported barrier to the helpline (n=610), or a general advisory text (care as usual as the control group: n=612). Effectiveness was evaluated using both behavioral and attitudinal measurements. The primary outcome measure was the use of a direct link to contact the helpline after completing the intervention or control condition. Secondary outcomes were the self-reported likelihood of contacting the helpline and satisfaction with the received self-test. Results: In total, 2124 website visitors completed the Suicidal Ideation Attributes Scale and the demographic questions in the entry screening questionnaire. Among them, 1222 were randomized into the intervention or control group. Eventually, 772 respondents completed the randomized controlled trial (intervention group: n=369; control group: n=403). The most selected barrier in both groups was "I don't think that my problems are serious enough." At the end of the trial, 33.1% (n=122) of the respondents in the intervention group used the direct link to the helpline. This was not significantly different from the respondents in the control group (144/403, 35.7%; odds ratio 0.87, 95% CI 0.64-1.18, P=.38). However, the respondents who received the BRI did score higher on their self-reported likelihood of contacting the helpline at a later point in time (B=0.22, 95% CI 0.12-0.32, P≤.001) and on satisfaction with the self-test (B=0.27, 95% CI 0.01-0.53, P=.04). For male and middle-aged respondents specifically, the results were comparable to that of the whole group. Conclusions: This trial was the first time the helpline was able to connect with high-risk website visitors who were hesitant to contact the helpline. Although the BRI could not ensure that those respondents immediately used the direct link to the helpline at the end of the trial, it is encouraging that respondents indicated that they were more likely to contact the helpline at a later point in time. In addition, this low-cost intervention provided greater insight into the perceived barriers to service. Follow-up research should be focused on identifying the added value of other components (eg, video or photo material) in the BRI and increasing its effectiveness, especially for men and middle-aged people.

Adapting an Online Guided Self-Help CBT Programme Targeting Disordered Eating for Students in Aotearoa New Zealand: A Qualitative Study.

Disordered eating is a significant issue in university student populations. Currently, access to interventions is limited. Online interventions present an innovative way to increase accessibility to treatment for those in need. The current study explored how an online intervention for disordered eating (everyBody) could be modified to suit the needs of university students in Aotearoa New Zealand. Aotearoa New Zealand is a unique cultural context, with an indigenous population that has a high incidence rate of disordered eating, highlighting the need to adapt everyBody to the local context. Individual interviews were conducted with nine students currently at university in Aotearoa New Zealand, aged between 18 and 33 years old (five females, four males). Three first-order themes were identified using template analysis. The themes indicate that participants perceived the programme as acceptable and feasible for use with Aotearoa New Zealand's university student population. Furthermore, the themes provide insight into potential adaptions to the programme to facilitate engagement and uptake. The suggested changes were largely consistent with previous research on E-therapy design (e.g., content length, therapeutic alliance), and also highlight changes specific to fit Aotearoa New Zealand's cultural context. The findings have implications for universities and other funders deciding on services for students with disordered eating and eating disorders.

Feasibility and Acceptability Study of a Culturally Adapted Web-Based Intervention to Reduce Suicidal Ideation for Syrian Asylum Seekers and Refugees in the United Kingdom: Protocol for a Mixed Methods Study.

BACKGROUND: The war in Syria has displaced over 6.8 million people, more than any other conflict since the Second World War. As a result, Syrian asylum seekers and refugees have experienced several life-changing events, resulting in high rates of anxiety, depression, posttraumatic stress disorder, and suicidal ideation (SI). To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI developed for general populations was culturally adapted for and with Syrian asylum seekers and refugees in the United Kingdom. The study revealed the importance of understanding their lived experience with migration and the acculturative process in providing treatment for SI. This study will now assess the feasibility and acceptability of the culturally adapted intervention for this population. OBJECTIVE: The first phase of the study will include recruiting participants and delivering the web-based intervention (1) to assess the feasibility of meeting recruitment goals and recruitment rates and (2) to assess the feasibility of outcome measures. The second phase of the study will include one-to-one semistructured interviews (1) to assess the suitability of the culturally adapted intervention in terms of recruitment and adherence rates and barriers and facilitators to engagement and (2) to assess the acceptability of the intervention in terms of its cultural relevance and appropriateness. METHODS: This is a protocol for a single-group, noncontrolled, mixed methods feasibility and acceptability study of a culturally adapted web-based intervention to reduce SI for Syrian asylum seekers and refugees in the United Kingdom. The study will assess the feasibility of recruitment goals, recruitment rates, adherence rates, and outcome measures using individual participant tracking forms, which will be analyzed quantitatively. The suitability and acceptability of the intervention will be assessed using one-to-one semistructured interviews with 12 participants who completed the intervention, which will be analyzed qualitatively. RESULTS: Recruitment began in February 2024 and will run until 30 participants are recruited to the study or until the end of July 2024. Thus far, 19 participants have provided informed consent, 16 were eligible and enrolled, and 12 have completed a postintervention interview. No data have been analyzed. The study, including the write-up period, is expected to end in December 2024. CONCLUSIONS: Despite experiencing several stressors related to forced displacement and high rates of mental health issues, access to treatment is still limited for Syrian asylum seekers and refugees in the United Kingdom. To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI was culturally adapted in collaboration with Syrian asylum seekers and refugees in the United Kingdom. This study will now assess the feasibility and acceptability of the intervention and culturally appropriate recruitment strategies. TRIAL REGISTRATION: ISRCTN ISRCTN11417025; https://www.isrctn.com/ISRCTN11417025. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/56957.

A web-based and mobile randomised controlled trial providing complementary feeding guidelines to first-time parents in France to promote responsive parental feeding practices, healthy children's eating behaviour and optimal body mass index: the NutrienT trial study protocol.

BACKGROUND: Childhood obesity is a crucial public health issue. Early childhood is a critical time to foster the establishment of healthy eating behaviours and growth, which are partly shaped by parental feeding practices. To inform French parents of the recently updated national complementary feeding guidelines for 0-3 years (in terms of nutrition and responsive feeding as a mean to encourage infant appetite control skills and promote healthy growth), an official printed brochure was developed and nationally disseminated in 2021 by the French public health agency, Santé publique France. This randomised controlled trial aims to investigate whether the provision of guidelines through digital (smartphone application) and printed (brochure) tools (vs. the printed brochure alone, usual service) results in healthier parental feeding practices, infant eating behaviours and weight status. METHODS: This double-blinded monocentric 2-arm trial is currently conducted among first-time parents living in the area of Dijon (France) and recruited in a maternity ward. From child age 3 to 36 months (mo), an app provides a range of 106 age-adapted messages, including dietary recommendations, educational advice, recipes, and tips (intervention group only). Additionally, parents of both groups are provided with 48 messages related to child general development and the printed brochure at child age 2.7 mo. The primary outcome is the body mass index (BMI) z-score at child age 36 mo. Secondary outcome measures include a combination of online parents' reports and behavioural assessments (experimental meals) of parental feeding practices and infant eating behaviours from inclusion to 36 months of age. Analyses of covariance on these outcomes will assess the effect of the intervention, adjusted for relevant confounders. Complementary mediation and moderation analyses will be conducted. Sample size was determined to be n = 118 in each arm of the trial, plus 20% to compensate for potential attrition. DISCUSSION: This is the first public eHealth randomised control trial in France to assess the effect of a web-based and mobile intervention targeted to first-time parents to improve child feeding practices and child growth. TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov as NCT05285761 (March 18, 2022).

Effectiveness of internet-based self-help interventions for depression in adolescents and young adults: a systematic review and meta-analysis.

OBJECTIVE: To assess the effectiveness of Internet-based self-help interventions in treating depression in adolescents and young adults. METHODS: A systematic search was conducted across six databases, including PubMed, to identify randomized controlled trials (RCTs) that satisfied the specified inclusion and exclusion criteria. The intervention measure consisted of Internet-based self-help interventions. RESULTS: A total of 23 randomized controlled trials (RCTs) were included in this analysis. Meta-analysis indicated that Internet-based self-help therapies significantly reduced depression scores in adolescents and young adults. (OR = -0.68, 95%CI [-0.88, -0.47], P < 0.001). We examined the effects of patient recruitment from various regions, medication usage, therapist involvement, weekly intervention time, and intervention duration. Patients selected from school, primary healthcare centers, clinics and local communities had better results. Intervention lasting 30 to 60 min and 60 to180 minutes per week were effective in the short term. CONCLUSION: The internet-based self-help intervention can be effective in treating depression in adolescents and young adults. However, factors such as patient recruitment locations, medication usage, Therapists' involvement, weekly intervention time, and intervention duration interacted with the outcome. Subgroup analysis on potential adverse effects and gender was impossible due to insufficient data from the included studies.

Is Web-Based Diabetes Training Effective or Ineffective on the Quality of Life of Individuals with Type 2 Diabetes Mellitus?: A Systematic Review.

Diabetes mellitus is called as the "pandemic of the era" due to its rising prevalence. Since it is a disease that affects all spheres of life, it has an impact on the quality of life of individuals. This systematic review aims to examine the effect of web-based diabetes training programmes prepared for individuals with type 2 diabetes mellitus on their quality of life. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta Analysis Protocols) flowchart was used in the literature search stage. A comprehensive search was performed through the [MeSH] keywords (Web-based Intervention, Randomised Controlled Trial, HRQOL, Type 2 Diabetes) until May 8, 2024 in databases of PubMed, Web of Science, Science Direct, Medline, CINAHL, EBSCO host, Cochrane Library, and Google Scholar. Zotero software program was used to identify duplications of the obtained studies. Seven randomised controlled studies were included in the review. It was found that, most of the studies that were included in review showed that quality of life did not cause any significant difference in the level of quality of life; whereas, improvement was observed in quality-of-life levels in all of the experimental groups. Also, studies conducted for 1.5 to 3 months showed that web-based training was effective in improving the quality of life. Consequently, it is recommended that web-based trainings be long enough to prevent patients from dropping out of training, with possibility of an online individual interview, and follow-up periods of 1.5 to 3 months in order to achieve effective results. PROSPERO Number: CRD42024530777.

A Web-Based Antiretroviral Therapy Adherence Intervention (Thrive With Me) in a Community-Recruited Sample of Sexual Minority Men Living With HIV: Results of a Randomized Controlled Study.

BACKGROUND: Most new HIV infections are attributed to male-to-male sexual contact in the United States. However, only two-thirds of sexual minority men living with HIV achieve an undetectable viral load (UVL). We tested a web-based antiretroviral therapy adherence intervention called Thrive with Me (TWM) with core features that included medication self-monitoring and feedback, HIV and antiretroviral therapy information, and a peer-to-peer exchange. OBJECTIVE: We assessed the efficacy of TWM on HIV UVL among adult (aged ≥18 years) sexual minority men. Moreover, we assessed the impact of overall engagement and engagement with specific intervention features on HIV UVL. METHODS: In total, 401 sexual minority men (mean age 39.1, SD 10.8 y; 230/384, 59.9% African American) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control) for 5 months. Computerized assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of HIV UVL (≤20 copies/µL). Generalized estimating equations with robust SEs were used to assess the effect of the TWM intervention on HIV UVL over the follow-up period in an unadjusted model and a model adjusted for baseline differences and then stratified by baseline recent drug use urinalysis. In secondary analyses, generalized linear models were used to estimate risk differences in the association of overall engagement with TWM (the sum of the number of days participants accessed ≥1 screen of the TWM intervention out of a possible 150 days) and engagement with specific TWM components on HIV UVL throughout the 17-month intervention period. RESULTS: Participant retention was 88.5% (355/401; month 5), 81.8% (328/401; month 11), and 80.3% (322/401; month 17). No consistent differences in HIV UVL were found between those randomized to receive TWM or the control at the 5- (difference-in-differences [DD]=-7.8, 95% CI -21.1 to 5.5), 11- (DD=-13.9, 95% CI -27.7 to 0.04), or 17-month (DD=-8.2, 95% CI -22.0 to 5.7) time points, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high overall levels of engagement (in the upper 25th percentile) were more likely to have an HIV UVL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile; risk difference=17.8, 95% CI 2.5-33.0) or no engagement (risk difference=19.4, 95% CI 3.3-35.5) in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with HIV UVL over time in unadjusted models. CONCLUSIONS: TWM did not have overall impacts on HIV UVL; however, it may assist some sexual minority men who are highly engaged with this web-based intervention in achieving HIV viral suppression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/study/NCT02704208.

Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial.

BACKGROUND: The COVID-19 pandemic has had an impact on mental health worldwide. Low- and middle-income countries were largely affected by it. Mexico was one of the most affected countries. Extended periods of lockdowns, isolation, and social distancing, among other factors, highlighted the need to introduce web-based psychological interventions to the Mexican population. In this context, Mental Health COVID-19 emerged as a self-guided web-based intervention (SGWI) aimed at adults to improve mental health during the COVID-19 pandemic. OBJECTIVE: This study aims to assess the efficacy of 2 modalities of a self-guided intervention (with and without chat support) in reducing depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation. In addition, it aimed to compare the moderating role of coping strategies, acceptance, and satisfaction in participants' symptom reduction. We hypothesize that the self-guided, chat-supported modality will show higher efficacy than the modality without chat support in achieving clinical change and better performance as a moderator of depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation, as well as an increase in participants' satisfaction and acceptability. METHODS: A randomized controlled trial was conducted. Data were collected from May 2020 to June 2022. We performed intrasubject measures at 4 evaluation periods: pretest, posttest, and follow-up measurements at 3 and 6 months. Differences between intervention groups were assessed through the Mann-Whitney U test for continuous variables and the chi-square test for categorical variables. Changes due to intervention were analyzed using Wilcoxon W test. Moderated regression analysis was performed to test the hypothesized moderating role of coping strategies, usability, and opinion about treatment on clinical change. RESULTS: A total of 36 participants completed the intervention; of these, 5 (14%) were part of the SGWI group, and 31 (86%) were on the SGWI plus chat support (SGWI+C) group, which included a chat service with therapists. The perceived high complexity of the system for the SGWI group had a moderating effect associated with a lack of efficacy of the intervention regarding depression, but not when controlled for sociodemographic variables. A perception of lower helpfulness of the intervention was associated with poorer outcomes. Coping strategies did not show moderating effects. CONCLUSIONS: Enhancing the utility of web-based interventions for reducing clinical symptoms by incorporating a support chat to boost treatment adherence seemed to improve the perception of the intervention's usefulness. Web-based interventions face several challenges, such as eliminating complexities in platform use and increasing the users' perceived utility of the intervention, among other issues identified in the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/study/NCT04468893?tab=results. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23117.

Online Personal Training in Patients With Marfan Syndrome: A Randomized Controlled Study of Its Impact on Quality of Life and Physical Capacity.

BACKGROUND: Marfan syndrome (MFS) is a genetic disorder affecting the vascular and musculoskeletal systems. Limited knowledge exists regarding the exercise benefits for this population. This study aimed to explore the impact of a structured exercise program on the quality of life (QoL) and physical capabilities of patients with MFS. METHODS AND RESULTS: This was a randomized, controlled, parallel-group trial. Patients with MFS were randomized in a 1:1 ratio to either a training group or a control group. The trial included a 3-month online supervised training program. Seventy patients with MFS were compared with healthy subjects. They were randomized into a training group (MFS-T) and a control group (MFS-C). The training consisted of 2 supervised online sessions weekly for 3 months. The primary outcome was QoL, assessed using the Medical Outcomes Study Short-Form 36 questionnaire. Baseline QoL in all dimensions was lower in patients with MFS. Their peak oxygen uptake was 25% lower, and muscle elasticity was diminished compared with healthy subjects. Postintervention, significant improvements were observed in the MFS-T group relative to the MFS-C group: QoL (+20.2±14.3 versus +0.7±0.5), peak oxygen uptake (+34% versus +14%), muscle elasticity index (11.5±8.2 versus +1.2±1.7), reduced blood pressures during isometric squats (systolic -19±30 versus 0±6; diastolic -27±39 versus +2±15), and reduced pulse wave velocity at rest (-1.20±1.89 versus -0.40±1.61) and postexercise (-0.42±0.45 versus +0.08±0.48). The aortic diameter remained stable in both groups (MFS-T-0.19±1.1 versus MFS-C+0.11±0.78). After training, QoL remained lower in MFS-T than in healthy subjects, but peak oxygen uptake, pulse wave velocity at rest, and postexercise were similar to those of healthy subjects. CONCLUSIONS: The 3-month online training program significantly enhanced QoL and cardiovascular/muscular metrics in patients with MFS without affecting aortic root diameter, suggesting its potential as part of a management strategy for MFS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04553094.