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Showing 1-8 of 8 trials
NCT04799197
This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV prevention continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. We will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.
NCT06362837
This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.
NCT06549777
This Pilot Randomized Controlled Trial (RCT) overall aim is to establish the safety, feasibility, acceptability and preliminary effects of a body-oriented psychotherapy, Somatic Experiencing (SE), on social functioning and mental health among adults with a history of Child Maltreatment (CM) and symptoms of posttraumatic stress disorder (PTSD) or complex posttraumatic stress disorder (CPTSD). Participants will be randomized either to an SE-group (n=25, psychoeducation, and information about treatment possibilities + 15-session SE treatment) or to a control group (n=25, same psychoeducation and information about treatment possibilities + regular phone calls to provide updates on their well-being and if they started a treatment). Given the lack of research on the effect of SE on Psychological Safety in this population, while SE has not yet been introduced into the Swedish health care system, special consideration will be given to participant safety, feasibility and acceptability of the SE-treatment. This includes monitoring (and assessing) for serious adverse events (SAEs) and adverse events (AEs), if conducting an RCT on SE in our target sample is feasible (e.g., achieving the target sample goal, assessing attrition rates and session attendance) and the acceptance of the used SE intervention (e.g., positive evaluations and willingness to recommend the treatment). Next to assessing safety, feasibility and acceptability, preliminary outcomes (self-report and experimental measures) will be evaluated at pre-treatment, post-treatment (20 weeks after pre), and at a 20-week follow-up, assessing primary outcomes (Psychological Safety) and secondary outcomes (Social Safeness, PTSD, CPTSD, Depression), as well as additional factors (e.g., interoception) that could contribute to decreased mental health and social functioning issues. Additionally, participants' behavioral (e.g., interpersonal distance) and physiological responses (HR, HRV, EDA) to social stimuli will be assessed pre- and post-treatment in an experimental setup to explore SE's potential to reduce Negative Affect and increase Positive Affect (Activated, Relaxed, Safe/Content) in response to social stress.
NCT06575582
The goal of this clinical trial is to learn if and how so called "Digital Navigators" (DN) can help general practitioners, outpatient psychiatrists and psychologists as well as their treated patients to use digital mental health apps (DiGAs) and integrate it into their treatment. The main questions it aims to answer are: * What are the chances and implementation barriers of DN? * What are the acceptance and expectations towards DN? * Do DN affect the psychological health of patients? * Do DN affect the digital health literacy and technical competence of participants? Employees of medical teams (e.g. medical assistants) receive training to become a DN. Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder.
NCT04693585
The goal of the study is to assess the feasibility and acceptability of the optimized MeSSSSage intervention which was developed and revised based on the results of our initial pilot testing. The investigators will conduct a controlled 4-arm factorial design randomized study to test the feasibility, acceptability and preliminary effectiveness of several intervention modalities over a 6-month period.
NCT06404632
Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.
NCT06136702
This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).
NCT04614220
Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.