Development and Implementation of DIALOG+S in the School Setting as a Tool for Promoting Adolescent Mental Well-Being and Resilience in a Post-Armed Conflict Area in Colombia: Exploratory Cluster Randomized Controlled Trial.

BACKGROUND: Educational settings are ideal for promoting mental well-being and resilience in children. The challenges of the COVID-19 pandemic made evident the important role that teachers and school counselors play in the mental health of their students. Therefore, it is imperative to develop and implement cost-effective interventions that allow them to identify and address mental health problems early, especially in post-armed conflict areas, to reduce the burden of mental disorders in this population. OBJECTIVE: This study aimed to adapt an existing patient-focused digital intervention called DIALOG+ from an adult clinical setting to an adolescent educational setting and to assess the feasibility, acceptability, and estimated effect of implementing this intervention as a tool for promoting quality of life, mental well-being, and resilience. METHODS: We conducted an exploratory mixed methods study in 2 public schools in postconflict areas in Tolima, Colombia. This study was conducted in 3 phases. In the adaptation phase, focus groups were conducted with students and teachers to identify changes required in DIALOG+ for it to be used in the school setting. The exploration phase consisted of an exploratory cluster randomized controlled trial. A total of 14 clusters, each with 1 teacher and 5 students, were randomly allocated to either the experimental (DIALOG+S) group or to an active control group (counseling as usual). Teachers in both groups delivered the intervention once a month for 6 months. Through screening scales, information was collected on mental health symptoms, quality of life, self-esteem, resilience, and family functionality before and after the intervention. Finally, the consolidation phase explored the experiences of teachers and students with DIALOG+S using focus group discussions. RESULTS: The changes suggested by participants in the adaptation phase highlighted the central importance of the school setting in the mental health of adolescents. In the exploratory phase, 70 participants with a mean age of 14.69 (SD 2.13) years were included. Changes observed in the screening scale scores of the intervention group suggest that the DIALOG+S intervention has the potential to improve aspects of mental health, especially quality of life, resilience, and emotional symptoms. The consolidation phase showed that stakeholders felt that using this intervention in the school setting was feasible, acceptable, and an enriching experience that generated changes in the perceived mental health and behavior of participants. CONCLUSIONS: Our results are encouraging and show that the DIALOG+S intervention is feasible and acceptable as a promising opportunity to promote well-being and prevent and identify mental health problems in the school context in a postconflict area in Colombia. Larger, fully powered studies are warranted to properly assess the efficacy and potential impact of the intervention and to refine implementation plans. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) registry ISRCTN14396374; https://www.isrctn.com/ISRCTN14396374. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/40286.

A Peer-Led Digital Intervention to Reduce HIV Prevention and Care Disparities Among Young Brazilian Transgender Women (The BeT Study): Protocol for an Intervention Study.

BACKGROUND: The HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and other low- and middle-income countries, with evidence of increasing new infections among young people. There is an urgent need for youth-specific HIV prevention and care interventions for young transgender women in Brazil. OBJECTIVE: This study aims to (1) address stigma in the Brazilian public health system and (2) reduce barriers to HIV care and prevention with systems navigation among young transgender women aged 18-24 years in Rio de Janeiro, Brazil. METHODS: The Brilhar e Transcender (BeT) study is a status-neutral, peer-led, single-arm digital intervention study enrolling 150 young transgender women in Rio de Janeiro, Brazil. The intervention was pilot tested and refined using data from a formative phase. The BeT intervention takes place over 3 months, is delivered remotely via mobile phone and in person by peers, and comprises three components: (1) BeT sessions, (2) digital interactions, and (3) automated messages. Eligibility criteria include identifying as transgender women, being aged 18-24 years, speaking in Portuguese, and living in the Rio de Janeiro metropolitan area in Brazil. The primary outcomes are HIV incidence, pre-exposure prophylaxis uptake, linkage to HIV care, and viral suppression. Primary outcomes were assessed at baseline and quarterly for 12 months. Participants respond to interviewer-based surveys and receive tests for HIV and sexually transmitted infections. RESULTS: The study has been approved by the Brazilian and the US local institutional review boards in accordance with all applicable regulations. Study recruitment began in February 2022 and was completed in early July 2022. Plans are to complete the follow-up assessment of study participants on July 2023, analyze the study data, and disseminate intervention results by December 2023. CONCLUSIONS: Interventions to engage a new generation of transgender women in HIV prevention and care are needed to curb the epidemic. The BeT study will evaluate a digital peer-led intervention for young transgender women in Brazil, which builds on ways young people engage in systems and uses peer-led support to empower transgender youth in self-care and health promotion. A promising evaluation of the BeT intervention may lead to the availability of this rapidly scalable status-neutral HIV intervention that can be translated throughout Brazil and other low- and middle-income countries for young transgender women at high risk of or living with HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT05299645; https://clinicaltrials.gov/ct2/show/NCT05299645. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44157.

Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth).

BACKGROUND: Current guidelines emphasize cancer patients should increase their physical activity levels, encouraging physical exercise practice as a complementary therapy to mitigate adverse effects during treatment. Telehealth can be a feasible method to improve adherence and interventional support for breast cancer patients, of which most do not meet sufficient physical activity levels after diagnosis. The Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth) study aims to investigate the effects of a 12-week telehealth multicomponent training program plus a health education program (MTHE), compared to a health education program alone (HE), on physical and psychological outcomes in breast cancer patients undergoing treatment. METHODS: This study is a randomized controlled trial. Women undergoing primary treatment (during or after chemotherapy) for breast cancer (stages I-III) will be randomly assigned to MTHE (twice a week) or HE (once a week). MTHE components are mobility, aerobic, balance, resistance, and flexibility home-based exercises, supervised by video call. The primary study outcome is cancer-related fatigue. The secondary outcomes are quality of life, symptoms of depression and anxiety, physical activity level, cancer-related cognitive impairment, and functional capacity. Other outcomes are adherence to interventions and a follow-up questionnaire evaluating the individual perception in motivation, lifestyle changes, and main barriers to participation. All outcomes will be remotely assessed before and after intervention. Our analysis will follow the intention-to-treat approach and per-protocol criteria, with additional sub-group analysis. DISCUSSION: To our knowledge, this is the first randomized clinical trial in breast cancer patients using a face-to-face videoconference strategy to supervise physical exercise. Our hypothesis is of superiority for the effects of MTHE on primary and secondary outcomes compared to the effects of only the health education intervention. TRIAL REGISTRATION: Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth), NCT04641377. Registered on 23 November 2021, https://clinicaltrials.gov/ct2/show/NCT04641377.

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial

Objective: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. Methods: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. Results: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. Conclusions: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial.

OBJECTIVE: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. METHODS: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. RESULTS: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. CONCLUSIONS: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

Adapting DIALOG+ in a School Setting-A Tool to Support Well-being and Resilience in Adolescents Living in Postconflict Areas During the COVID-19 Pandemic: Protocol for a Cluster Randomized Exploratory Study.

BACKGROUND: Colombia has a long history of an armed conflict that has severely affected communities with forced internal displacement and violence. Victims of violence and armed conflicts have higher rates of mental health disorders, and children and adolescents are particularly affected. However, the mental health needs of this population are often overlooked, especially in low- and middle-Income countries, where scarcity of resources exacerbates the problem that has been further compounded by the global COVID-19 pandemic. Thus, special attention should be paid to the development of interventions that target this population. OBJECTIVE: Our research aims to adapt an existing patient-centered digital intervention called DIALOG+ from a clinical setting to an educational setting using stakeholders' (teachers' and students') perspectives. We aim to evaluate the feasibility, acceptability, and estimated effect of implementing this intervention as a tool for the identification and mobilization of personal and social resources to mitigate the impact of social difficulties and to promote mental well-being. METHODS: We will conduct an exploratory mixed methods study in public schools of postconflict areas in Tolima, Colombia. The study consists of 3 phases: adaptation, exploration, and consolidation of the DIALOG+ tool. The adaptation phase will identify possible changes that the intervention requires on the basis of data from focus groups with teachers and students. The exploration phase will be an exploratory cluster randomized trial with teachers and school counselors to assess the acceptability, feasibility, and estimated effect of DIALOG+ for adolescents in school settings. Adolescents' data about mental health symptoms and wellness will be collected before and after DIALOG+ implementation. During this phase, teachers or counselors who were part of the intervention group will share their opinions through the think-aloud method. Lastly, the consolidation phase will consist of 2 focus groups with teachers and students to discuss their experiences and to understand acceptability. RESULTS: Study recruitment was completed in March 2022, and follow-up is anticipated to last through November 2022. CONCLUSIONS: This exploratory study will evaluate the acceptability, feasibility, and estimated effect of DIALOG+ for adolescents in postconflict school settings in Colombia. The use of this technology-supported tool aims to support interactions between teachers or counselors and students and to provide an effective student-centered communication guide. This is an innovative approach in both the school and the postconflict contexts that could help improve the mental health and wellness of adolescents in vulnerable zones in Colombia. Subsequent studies will be needed to evaluate the effectiveness of DIALOG+ in an educational context as a viable option to reduce the gap and inequities of mental health care access. TRIAL REGISTRATION: ISRCTN Registry ISRCTN14396374; https://www.isrctn.com/ISRCTN14396374?q=ISRCTN14396374. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40286.

Internet-Based Intervention Compared to Brief Intervention for Smoking Cessation in Brazil: Pilot Study.

BACKGROUND: Smoking is still the leading cause of preventable death. Governments and health care providers should make available more accessible resources to help tobacco users stop. OBJECTIVE: This study describes a pilot longitudinal study that evaluated the efficacy of an internet-based intervention compared to the brief intervention for smoking cessation among Brazilians. METHODS: Eligible participants were recruited and randomly allocated to one of the two interventions. Measures were drawn by comparing cessation rates, motivation scores, and sought treatment between groups, assessed 1 and 3 months after the intervention. Inferential analysis was performed to compare the participants' characteristics, and the intention to treat was calculated. RESULTS: A total of 49 smokers were enrolled in this study (n=25, 51% in the brief intervention group; n=24, 49% in the internet-based intervention group). Mean age was 44.5 (SD 13.3) years; most were male (n=29, 59.2%), had elementary school (n=22, 44.9%), smoked 14.5 cigarettes per day on average (SD 8.6), and had a mean score of 4.65 for nicotine dependence and 5.7 for motivation to quit. Moreover, 35 (71%) participants answered follow-up 1, and 19 (39%) answered follow-up 2. The results showed similar rates of cessation and reduction for both intervention groups. CONCLUSIONS: The internet-based intervention was slightly more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. This difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size.

Digital psychosocial intervention for depression among older adults in socioeconomically deprived areas in Brazil (PRODIGITAL-D): protocol for an individually randomised controlled trial.

BACKGROUND: Depression in older adults is a challenge for health systems in most low- and middle-income countries (LMICs). Digital strategies for the management of this condition have been emerging worldwide, but the effectiveness of most of them is still unclear, especially among older adults. Thus, we aim to assess the effectiveness and cost-effectiveness of a digital psychosocial intervention to treat depression among older adults living in socioeconomically deprived areas in Guarulhos, Brazil. METHODS: We will conduct a two-arm individually randomised controlled trial with 1:1 allocation ratio. Five hundred older adults aged 60 years or over with depressive symptomatology (9-item Patient Health Questionnaire score, PHQ-9 ≥ 10) and registered with one of the primary care clinics will be recruited to participate in this study. A 6-week digital psychosocial programme, named Viva Vida, will be delivered via WhatsApp to participants allocated to the intervention arm. The Viva Vida will send psychoeducational and behavioural activation audio and visual messages 4 days a week for 6 weeks. The control arm will only receive a single message with general information about depression. The primary outcome will be the proportion of depression recovery (PHQ-9 < 10) assessed at 3 months. The cost-effectiveness of the intervention will be assessed at 5 months. A detailed process evaluation will be used to explore context and important implementation outcomes. DISCUSSION: This programme was based on the PROACTIVE intervention and designed to be delivered without face-to-face contact. If effective, it could be a simple treatment option, appropriate not only when social distancing is required, but it could also be included as a regular public health programme to initiate depression treatment, particularly in LMICs where resources allocated to mental health are scarce. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).

Hybrid and Remote Psychosocial Interventions Focused on Weight and Sedentary Behavior Management Among Patients with Severe Mental Illnesses: a Systematic Review.

Severe mental illness could be defined through its diagnosis, disability, and duration, and one of their main characteristics is the high prevalence of some clinical conditions such as obesity and metabolic syndrome. Although the promotion of a healthier lifestyle has been demonstrated as an effective strategy to reduce both body mass index and abdominal circumference in this population, there is a lack of studies focusing on digital intervention in this population. The aim of this systematic review was to evaluate the efficacy of studies that used digital technologies to reduce weight, body mass index (BMI) and abdominal circumference in individuals with severe mental illness. This current review also compared remote and hybrid interventions, the effects of those interventions in metabolic biomarkers as well as in the development of a healthier lifestyle. The main findings included the following: (a) the use of digital devices or strategies might be feasible and useful to reduce sedentary behavior among individuals with severe mental illnesses, 2) most interventions used digital pedometers and mobile phone communication (either text messages or phone calls) as main strategies, 3) all remote interventions and six of nine hybrid interventions found significant outcomes in favor of their interventions. In conclusion, even with a limited number of studies promoting healthier lifestyle through digital interventions among individuals with severe mental illnesses, evidence from studies included in this review showed that they might be useful to improve a healthier lifestyle and increase the frequency of physical activity behavior.