Stress
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Healthy Volunteer
In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2). The primary aim is to assess any possible predictive effect of erectile function status on cardiac events. The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups. The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention. All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study. The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months. 3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse. The surveys include: IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale ) The objective scale we use: Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral ) The survey will take place in our institutions. The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event. Myocardial infarction causes significant changes in erectile function in a natural survey. The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.
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Healthy Volunteer
The research activities of phase 1 and 2 will include purposively recruiting participants for focus group discussion and in-depth interviews. The implementation team will help us identify the key stakeholders in the communities. While the consent form for key stakeholder will be used for all other participants of phase 1 and 2, the consent for phase 1, 2 and 3 for young adults will be covered under 1) consent for parents, if age of participants in intervention is less than 18 and 2) participant consent if they are above 18. Phase 3 of research will follow different process. Phase 3 for children to participate in the study, who are of age less than 18, the parents will be contacted for consent, first a set of screening questions will be asked to determine the eligibility of the participant for the study, once found eligible, a baseline interview will be conducted for collecting non-identifiable socio-demographic, data of the family. The informed consent is sought at this point. The participant will undergo the interviews for the validated questionnaires at 3 time points. Once before the intervention starts, once after 12 months of intervention and once after 18 months of intervention. The consent form for parents to seek permission for participation of the these participants covers all the three phases of the study. Screening and recruitment process: The screening will be a verbal process where the participants will be assessed whether they are eligible for participation. The baseline interview to collect data of the non-identifiable socio-demographic data. The data points to be collected are; 1) details about the land ownership, 2)cattle ownership, 3) type of house, 4) nature of family income, 5) source of water, 6)electricity, 7) material possessions at 'your' (participant's) home (TV, two-wheeler, mobile phone).These details will be used for understanding the socio-economic differences among the participants. Those who qualify to take part in this research study will attend two or more, one and half hour sessions every week, for the duration of one year. They will be assigned a code (name/village/household information will not appear in any document) and placed in one of the 'One-all' groups. Each of the 'One-all' groups will have approximately 20 participants (which will undergo organized sessions and ultimate frisbee game for the duration of the study). The following questionnaires will be administered to the participants as part of evaluation: 1. Connor-Davidson resilience scale (CD- RISC) to measure participant's capacity to bounce back from adversities. 2. The Child Youth Resilience Measure (CYRM) - to measure participant's capacity to bounce back from adversities. 3. GHQ12, a validated measure of participant's mental well-being. 4. Schwarzer's General Self-Efficacy Scale (GSE), to measure participant's self-efficacy. Questionnaires 1-4 will be administered at 3 time points: First time point is the baseline (before the first One-all session); second time point will be at the end of 12 months of receiving one-all sessions and third time point will be after 18 months of receiving One-all sessions as Endline.The participant will undergo intervention provided by the One-all implementation team. Implementation team will visit the communities for enrolling the participants for the intervention. This team will pass on the list of participants who have enrolled for the intervention to the research team. One-all programme delivery by implementation team (separate from research) The three-year curriculum is structured as a series of chapters followed by a year-end event usually a workshop or a tournament. Each chapter begins with an introduction that outlines the major content of the chapter, with topics and their objectives. Lesson plans have been created by the One All curriculum development team for each of these topics. Each session is designed to take maximum of one and half hours. The suggested time is considered the components. However, the lessons can always be expanded on a given day, or spread out over one or more days, for deeper and more graduated learning as time permits. Each session has the following 4 parts: 1. Warm up: provides the opportunity to prepare the children to become familiar with the learning topic for the day through a fun activity that is related to the topic. 2. Drills: are sporting activities that are more physically involved, but also connected to the application of the learning topic. 3. Game: is a mixed-gender "ultimate frisbee" match with modified rules to emphasize the application of the learning topic. 4. Spirit circle: Group discussion that is used to reflect and share the learning of the day. It also guides children in making thoughtful connections that anchor the learning. The implementation team will keep the records pertaining to attendance and the reflections of the sessions in detail. The research team will use these records. No medical records will be accessed through the course of the study.
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Healthy Volunteer
This study aims to examine the effect of productivity training on nurses' perceived job stress and attitudes toward productivity. It was designed as a randomized controlled experimental study with a pre-test, post-test, and follow-up design. The experimental group will receive a three-week structured productivity training program, while the control group will not receive any intervention during the same period. Data will be collected using the Personal Information Form, the Nurses' Attitudes Toward Productivity Scale, and the Perceived Job Stress Scale. It is hypothesized that nurses who participate in the productivity training will report lower perceived job stress and higher productivity attitudes compared to those in the control group.
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Healthy Volunteer
Black young gay, bisexual and other men who have sex with men (B-YGBMSM) and transgender women (B-YTW) are disproportionately affected by HIV/AIDS in the U.S. Youth in the House Ball Community (HBC), a subculture of the Black gay community that offers a social network to freely express diverse sexual and gender identities, are among the most at-risk for HIV infection and loss to care, but barriers exist to the provision of HIV services within this community. One barrier is the increasing rates of violence. Interventions are needed that will interrupt the cycle of violence within the HBC to allow for adequate provision of HIV services and increased access to HIV care. The investigators propose to tailor the Cure Violence model for violence prevention for developmental-appropriateness, cultural-specificity and HIV relevance, then pilot test the new intervention (#ChopViolence/#ChopHIV) with B-YGBMSM and B-TW in the Chicago HBC. The proposed research activities will take place in six steps. In Step 1, the investigators will hold Youth Advisory Board meetings, finalize our assessment battery and conduct multiple baseline assessments (months 3, 9 \& 15; n=75 per assessment point) at HBC venues to track trends in violence (i.e., intimate partner, HBC and neighborhood violence), HIV stigma, substance use, mental health, sexual risk and HIV care engagement. In Step 2, the investigators will employ ADAPT-ITT strategies for adapting evidence-based interventions including conducting a series of focus groups (n=32) with youth and leaders from the HBC in order to identify persuasive messaging around decreasing violence and improving HIV outcomes. Based on the focus group data as well as consultation with community experts, the investigators will then tailor the intervention to be relevant for the Chicago HBC and develop training materials along with standard operating procedures. In Step 3, the investigators will identify, recruit and train trusted members of the HBC to work as Violence Interrupters (VI) or Outreach Workers (OW). VI and OW will undergo training over the course of several weeks. Training activities include didactic seminars, webinars from the Cure Violence team, HIV education, conflict mediation skills and mock interruption and outreach activities. In Step 4, the investigators will pilot test the tailored intervention. VI will monitor HBC events as well as social media venues for potential violence and intervene. OW will build their client caseload with HIV+ youth identified as of highest-risk for violence and schedule sessions, phone calls, and assist with HIV care linkage. In Step 5, the investigators will conduct follow-up assessments (months 21, 27 \& 33; n=75 per assessment point) at HBC events to continue to monitor trends in violence, HIV stigma, substance use, mental health, sexual risk and HIV care engagement. Qualitative interviews will be conducted with VI, OW and HIV+ intervention clients to explore the processes and strategies of intervention implementation, with a focus on implementation barriers and facilitators. Finally, in Step 6, the investigators will conduct data analysis, disseminate findings and produce scientific publications.
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Healthy Volunteer
Rationale: While the adverse effects of domestic violence on victimized parents and children have been extensively documented, there is still little knowledge on effective intervention approaches for these families. Both parents and children are at risk to develop trauma-related psychopathology after domestic violence. In addition, victimized parents are likely to show disrupted parenting due to their own traumatization (resulting from domestic violence and often also from their own traumatic childhood). This increases the risk for developing a disturbed attachment relationship for the child. Treatment should thus focus at improvement on three levels (parenting behavior and post-traumatic stress (PTSD) symptoms of the parent and the child), and can consist of trauma therapy for parent and child and attachment-based therapy. Since the symptoms in different families may exhibit in different ways, and can interact with each other in a different way, an individualized treatment trajectory that takes these interactions in account may be necessary to allow for maximum symptom reduction. Study design: The hypotheses will be tested using a single case experimental design (SCED) study, with a non-concurrent, randomized multiple baseline design. Families who receive treatment after experiencing severe domestic violence will be randomly assigned to a baseline length of 3, 4, 5, 6, 7 or 8 weeks (phase 1), and randomization will occur for two sets of five participants. After the end of the baseline phase, the intervention phase will start, during which dyads will follow an individualized treatment trajectory, consisting of different treatments (phase 2), including EMDR therapy for parent and child to reduce their PTSD symptoms and NIKA to reduce disrupted parenting behavior and increase sensitive parenting behavior. The dyads will participate in weekly appointments throughout the whole duration of the study (both baseline and treatment phase). Study population: This study will include 10 parent-child dyads who are residing at a community shelter location in the Netherlands after experiencing domestic violence. Parents with children aged between 4-6 years old will be included if both the parent and the child experience clinically important PTSD-symptoms (based on self-report of the parent). In case that not enough parent-child dyads can be recruited, based on the eligible age range of the child, the age range for the children will be widened, so that children aged between 3-6 years can participate.
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Healthy Volunteer
Introduction Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses. Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, research to date has predominantly been single-group designs with a lack of a control group and randomization. This contributes to limitations in the confidence and quality of the implications drawn from the synthesized studies. Indeed, within a post-secondary context, most studies are noted as poor quality and lack critical information regarding how they are designed, delivered, and made accessible to students. Second, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology reduction) and secondary (i.e., social support, social connectedness) outcomes. Importantly, group-based physical activity, in comparison to 1:1 delivered physical activity, may provide a less costly and less resource intensive intervention option, and may have unique benefits associated with exercising with others and peer-to-peer support (e.g., social support, a sense of belonging, expanded social networks). Third, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. As such, conclusions concerning achieving lasting change to mental health and sustained physical activity involvement are not possible. Lastly, limited research has explored contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of such programming opportunities. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. Objectives and Hypotheses This randomized controlled trial study will assess the immediate (post-intervention, 6 weeks) and follow-up (4 weeks after post-intervention) maintenance effects of 1:1 supervised physical activity and group-based physical activity in comparison to a 10-week waitlist control group in reducing symptoms of poor mental health, supporting social well-being outcomes, and facilitating physical activity behaviour among post-secondary students experiencing poor mental health. The primary outcomes will be the immediate change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress). The secondary outcomes will include follow-up change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress) as well as the immediate and follow-up change in social well-being outcomes (social connectedness, social support), and physical activity behaviour. The aims of the study include: (1) examining group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes; and (2) grounded in process evaluation recommendations, to explore contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. Study Setting The trial will be delivered in the post-secondary setting of a large metropolitan university. Importantly, post-secondary contexts offer natural advantages for large-scale implementation of physical activity programs for student mental health because they offer essential infrastructure (e.g., an integrated setting with access to sport and recreation facilities and mental health services) and practical support (e.g., experts in diverse fields) to develop, evaluate, and disseminate sustainable and scalable programs. Aligning with this perspective, the current study will employ a collaborative implementation approach, whereby the research team will work with on-campus sport and recreation professionals (i.e., for the provision of certified coaches with standard training in behavior change coaching and physical activity delivery) and mental health professionals in the post-secondary community (i.e., for program design, recruitment and implementation, and evaluation). In addition, purposeful efforts (e.g., through advocating for targeted referrals to the program and delivering targeted information sessions) will be made to promote the program among professionals (e.g., accessibility services, student-life services, health and wellness services) involved with providing mental health support or referrals to on-campus support services- an important approach for facilitating collaboration across disciplines and sectors in the campus community. Participant Timeline The university research ethics board (REB) has approved this study (protocol # 00045228). Students who meet eligibility and who have provided informed consent will be contacted to schedule an intake session with a program coordinator for the trial. Students who do not meet eligibility will be notified via email by the program coordinator and will be provided with a mental health resource sheet outlining alternative health and wellness programs and resources available to participate in. Intake sessions will be scheduled in-person in a private research space conveniently located in the campus athletics and recreation centre. During the intake session, participants will complete the baseline assessment (T1), and randomization will be conducted. Following completion of the intake session, participants in the experimental arms will complete the 6-week physical activity program (either 1:1 physical activity delivery or group-based physical activity delivery). In the experimental arms and control condition, study outcomes will be assessed at baseline (T1), 6-weeks post baseline (T2), and at 1-month follow-up (T3). Sample Size A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures design would require 25 participants per group assuming a moderate effect size of .30, a power level of .80, an alpha of .05, and expected correlations between timepoints of r = .50. To account for a loss to follow-up rate of 25%, the final targeted sample size is 93 post-secondary students. Participants will be randomly assigned to equal groups of approximately 31 students. Recruitment Purposive and snowball sampling procedures will be used to recruit post-secondary students who are physically inactive and experiencing poor mental health. Post-secondary students will be recruited and referred to the intervention through the team's research and professional networks (e.g., health and wellness and student support services; student life listservs; campus mental health listservs; the research team's social media platforms including Twitter and Instagram). Digital recruitment materials (including email scripts and poster advertisements) outlining the purpose of the intervention, intervention procedures, eligibility criteria, and a link to the screening questionnaire will be shared. The screening questionnaire will be administered through REDCap and allow participants to "sign up" up for the intervention through providing their email address and completing several screening questions to confirm eligibility. The program coordinator will contact eligible participants through their provided email address to confirm involvement in the study and to schedule an intake meeting. Data Collection Methods Statistical Methods Preliminary analyses will include descriptive statistics (including mean scores for study variables, standard deviations, frequency counts for categorical variables and bivariate correlations) to examine the relationships between study variables and to describe participant characteristics. A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures ANOVA will be used to examine whether there are group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes. Lastly, the implementation process evaluation outcomes will be assessed analyzing the responses to the closed-ended and open-ended questions. Closed-ended questions will be analyzed using descriptive statistics and open-ended questions will be analyzed using inductive thematic analysis. Methods Monitoring Harms There are minimal risks or harms associated with participating in the research trial. Nonetheless, the current sample represents a population with relevant group vulnerability due to self-reported mental health concerns. There are also inherent risks associated with engaging in physical activity. First, it is possible that the self-report assessments may provoke negative emotions or may elicit uncomfortable thoughts and/or feelings. To mitigate emotional risks, participants will be informed of their right to not answer questions they feel uncomfortable answering, and all participants will be provided with a mental health resource sheet following completion of the intake meeting. Participants will also be informed of their right to withdraw from the trial without any penalty to their involvement in the 6-week physical activity intervention. Second, physical risks are rare but include cardiac events and musculoskeletal injuries. To reduce the risk of injury, the physical activity sessions will be delivered by certified sport and recreation coaches who have received standard training in behaviour change coaching and physical activity program delivery. Participants will also receive clearance for physical activity engagement using the PAR-Q+ and will be informed to refrain from engaging in any physical activity causing sharp pain, nausea, dizziness, or light-headedness. Bi-weekly meetings with the research team and sport and recreation coaches to mitigate any risks or concerns for participant vulnerability throughout the duration of the study will be held. Ethics and Dissemination Protocol Amendments Protocol amendments, including but not limited to changes in the study objectives, the eligibility criteria, samples size, the outcomes, or statistical analyses will be submitted to appropriate REB review. Substantive changes will also be documented as amendments to the published study protocol and to the trial registry. Confidentiality All information collected for this trial will be kept strictly confidential. The information will be stored electronically in secure, password-protected folders only accessible to members of the research team. All data will be collected through a secure online data capture program (REDCap), where identifying information (i.e., email address, participant name) will be removed prior to data analysis. Data will be coded by participant ID and presented as aggregate-level data to maintain confidentiality and anonymity of the data.
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HIV care engagement is essential to optimize the health of Black women LWH. Black women LWH have poorer health outcomes due to exposures to poverty, substance use, and violence as well as constrained support resources derived from historically unjust social policies. Baltimore City has the highest prevalence rates of HIV in Maryland. In 2018, nearly 1 in 5 (18.7%) people living with HIV, the majority of whom are Black, were not engaged in HIV care and only two-thirds had achieved viral suppression. Two critical aspects of HIV care engagement include at least two HIV care visits in a 12-month period 90 days apart and a prescription for ART as early as possible after HIV diagnosis. HIV care engagement among Black women LWH can be challenging; and exposure to IPV is a well-established barrier. Black women LWH experience high rates of IPV victimization. Approximately 1 in 2 Black women report lifetime experiences of IPV compared to 1 in 3 White women. Women LWH and experiencing IPV are more likely to have a lower Clusters of differentiation 4(CD4) count and higher viral load; and delayed care poses heightened risks for ongoing HIV transmission in communities. Black women LWH also report higher rates of severe IPV, greater IPV frequency, and are more likely to be murdered by an abusive partner in the United States. Despite these stressors, fewer Black women experience IPV-related Post Traumatic Stress Disorder symptoms compared to White women, though they are also less likely to seek help from healthcare organizations. IPV impacts HIV care engagement among Black women LWH. Attending HIV care visits is a critical step to HIV care engagement because interactions with healthcare providers can increase access to life-preserving antiretroviral therapies and other resources to address IPV. However, Black women experiencing various types of IPV (psychological, physical, and sexual) are less likely to access HIV healthcare. Among women already engaged in healthcare, women experiencing IPV are also more likely to experience hospitalizations and longer care disruptions compared to women not experiencing IPV. Thus, Black women LWH have increased risks of clinical progression if IPV is a barrier to full HIV care engagement. Barriers to HIV visit attendance reported among individuals experiencing IPV in previous studies have included: psychological control of money and/or resources by abusive partners, fear of rejection or escalated violence in response to disclosure of HIV status, overall poor health, low self-esteem, low self-efficacy, and fears of stigma. The effects of stigma on HIV care engagement are pervasive among women experiencing HIV and IPV. The intersection of two socially devalued identities, HIV diagnosis and experiencing IPV, can cause psychological and emotional distress among BWLWHI. Factors driving stigmatization include societal beliefs that delegitimize BWLWHI, internalization of those beliefs, and fears about possible rejection if others know about their HIV status and IPV experiences. A recent systematic review found HIV-related stigma at multiple levels the most prevalent barrier to engaging in HIV care among Black women LWH. IPV stigma is a barrier to engaging with familial or friend networks for social support due to beliefs that women in violent relationships are irresponsible and unwise. Both of these societal stigmas are pervasive, and can affect individual decisions to employ IPV safety strategies and engage in HIV care. Black women use IPV safety strategies and build on existing sources of strength to overcome the effects of IPV and HIV. Several studies report Black women LWH and/or experiencing IPV draw on internal and external sources of strength and employ safety strategies to overcome stigmas and preserve or improve their health. Women experiencing IPV reported accessing sources of strength to gain motivation to change their situation, leave their abuser, or take care of their health. Internal sources of strength include spirituality/religion or belief in God and self-reliance or belief in oneself. External sources included accessing informal and formal resources for support. Examples of informal support resources included friends or family who cared about the woman. Among Black women LWH, social support from family members, friends, and peers were resources for resilience; fostering health promoting behaviors to cope with HIV. Formal support resources for Black women experiencing IPV were police or court systems, IPV organizations, and healthcare. Feelings of empowerment and resiliency derived from a shared identity, unique strategies for coping, and awareness of social and political meaning can preserve Black women's well-being in the face of adversity. Black women LWH identified healthcare providers as vital resources of resilience to maintaining health. Resilience is linked to higher quality of life, undetectable viral load, and improved medication adherence among this group. Identifying the numerous ways women cope with IPV and build on their existing capacities are characteristics of strengths-based intervention approaches using a resiliency-reintegration model. Strengths-based approaches engaging BWLWHI in care are lacking. Despite established links between IPV experiences and HIV care disengagement, few existing HIV care engagement interventions are tailored for Black women LWH nor do they address the effects of IPV on health. In fact, the majority of existing studies describe barriers and facilitators to care engagement but are not focused on interventions addressing these issues. The Living in the Face of Trauma (LIFT) intervention for women LWH found improved coping and reductions in traumatic stress 12 months after completing the intervention. However, this study did not focus on the role of current IPV. While strengths-based case management has been found to be a highly efficacious strategy to linking individuals to HIV care, it is resource-intensive and did not focus on the effects IPV can pose on this process. The negative influence of IPV experiences engagement in the distal outcomes of the HIV Care Continuum, i.e., medication adherence and viral suppression among Black women demonstrate potential areas for targeted intervention to address the effects of IPV and HIV-related stigma as barriers to HIV care visit attendance and receipt of ART. The 1MoreStep study refines and tests a 8-session cognitive behavioral approach intervention referred to as COPE. COPE is a mnemonic of the skills: Challenge negative and maladaptive thoughts, Options - internal and external sources of strength, Positive affirmations, and Establish a plan. The investigators expect that introducing COPE skills will lead to increased HIV care engagement and use of IPV safety strategies in a sample of BWLWHI ages 18 and older. The investigative team has a strong record of recruiting and retaining samples of Black women in Baltimore. The CHAT study (R01MH66810) was a Randomized Control Trial (RCT) testing a peer-based HIV prevention intervention with a sample of predominantly Black women. CHAT stands for: 1) Choose the right time and place; 2) Hear what the person is saying; 3) Ask Questions; and 4) Talk with respect. The Prevention and Testing study was a RCT testing an intervention for people LWH, 40% were Black women. The Young Women's Healthy Relationship (YWHR) study (R25-MH087217) was a cross-sectional study examining mental, sexual, and reproductive health effects of IPV and reproductive coercion among Black young women age 18 to 24 in Baltimore. The BMore PrEP Her Way (BHPHW) study (R24HD042854) recruited over 100 IPV-exposed women living in Baltimore to examine acceptability of women-controlled methods for HIV prevention (i.e. pre-exposure prophylaxis (PrEP)) and pregnancy prevention (long-acting reversible contraceptives (LARC)). Black women were 85% of the sample and 5% of the 250 screened ineligible were HIV-positive. Finally, myPlan, the IPV risk assessment and safety planning tool, that facilitators will introduce in Session 4 of the intervention was tested in diverse samples (\>20% self-identified as Black women) and found to be an effective intervention for women experiencing IPV. This study is a randomized, two-arm pilot clinical trial to determine acceptability, feasibility and preliminary estimates of efficacy of a trauma-informed cognitive behavior change program with 3-month and 6-month follow-up visits of BWLWHI (N=100). Participants complete baseline assessments and attend group sessions at a community-based research clinic. Follow-up assessments (satisfaction survey, qualitative interviews to assess acceptability and feasibility) will be conducted post-treatment and 3 and 6 months. Experimental Condition: The intervention arm includes 7 small-group sessions and one individual session that meet weekly with facilitators who are paraprofessional women, one of whom is indigenous to the Black community in Baltimore and has experience implementing prior cognitive behavioral skills interventions in addition to several other HIV prevention and care RCTs with marginalized populations including Black women. Session 1: The first session is an introduction of the purpose of the training and includes an activity about the strengths of BWLWHI and an inventory of internal and external sources of strength. Session 2: The intervention uses a mnemonic (COPE) to teach cognitive and behavioral skills, develop strategies for safety from IPV and improve knowledge and motivation for engagement in HIV care. Session 3: Teaches women about U=U and using COPE to address HIV care engagement. A female HIV care navigator will describe services offered at numerous clinics in Baltimore including the Baltimore Rapid Start Collaborative that provide immediate antiretroviral therapy to people newly diagnosed and/or re-engaging in HIV care. Participants will set HIV care goals. Sessions 4-5: These sessions are focused on conducting a personalized danger assessment and learning IPV safety strategies. In session 4, participants will meet in a small-group to learn about IPV safety strategies, specifically: placating strategies (e.g. not arguing with partner), safety planning (e.g. hiding car keys, keeping money hidden, having supplies ready for escape), engaging informal resources (e.g. sending kids to relatives) and formal resources (e.g. talking to a pastor, calling crisis line). Participants will be introduced to the myPlan app, which is a secure, interactive, and personalized app that has been developed and tested with diverse women (18 years and older) to support decisions to increase safety and reduce barriers to services. The myPlan app allows users to define their personal safety priorities, assess the level of danger in their intimate or dating relationship, and formulates a personally-tailored safety plan with referrals to appropriate resources and services. For the proposed study, no data will be used from the app. The app is a resource that will be shared with participants who are interested in voluntarily using it. The group will practice communication strategies for responding to enacted stigma which include positive affirmations such as "I am a survivor and doing the best I can for me and my kids", "One of my goals is to stay healthy for my kids, so going to the doctor is part of my plan", "I am worthy, HIV does not define me". Session 5 is an individual format in which the participant will identify the IPV safety strategies that she is willing to try and goal setting for safety planning. Session 6: The facilitator will discuss peer engagement, community building, and ways to support other Black Women Living With HIV (BLWHI). Session 7: This session is focused on goal setting for the next 30 days and establishing cues to remind the participant to practice the COPE skills. Session 8: Reunion session 30 days post completion of the intervention. Comparison Condition: The Equal Attention Control/Standard of care control arm will consist of 7 group-based sessions that meet weekly and last 60-90 minutes. The control sessions provide both equal attention and psychotherapeutic experience of a support group where participants can talk about issues that are important in their lives, improving equal retention by study arm. Session 1 will include a video entitled "Personal stories of people living with HIV" created by the Positive Life Campaign. Participants will share their experiences living with HIV and staff will give HIV care resources. Session 2 will be a standard of care presentation of IPV resources, services, and shelters for women. Sessions 3-5 will address diet-related health disparities that affect Black women such as obesity, hypertension and diabetes. Women will watch videos about each topic and then discuss their reactions. Session 6 will address caregiving and its relationship to self-care. Session 7 will address COVID-19 (transmission risks, symptoms and prevention behaviors) and related services available including food resources, financial assistance, testing sites and childcare. The investigators chose these topics because they are relevant to BWLWHI but not associated with the health outcomes targeted by the intervention. Follow-up Assessments: All participants will be asked to complete a survey at 3 and 6 months post baseline. The follow-up surveys will assess changes in IPV safety strategies and HIV care linkage. Two participants per cohort will be asked to conduct an in-depth feedback interview.
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Healthy Volunteer
Antidepressants typically decrease amygdala response to negative stimuli while enhancing response to positive stimuli, but it is unclear at a mechanistic level how increasing serotonin would have this opposing effect. One hypothesis is that although positive and negative cues activate the same area at a global level, more detailed characterisation may reveal key differences in processing in terms of localisation or response function. Until now, due to methodological restriction, the amygdala has been mostly studied as a single structure. It is however known that it consists of a number of subfields, which are likely to play distinct roles in emotional processing. In this study the investigators will make use of 7T fMRI scanning to study the effects of a single dose (20 mg) of citalopram (selective serotonin reuptake inhibitor, SSRI) on these subfields during emotional face processing, allowing greater precision to identify underlying neural mechanisms underpinning psychological effects.
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The investigators will conduct a pilot randomized controlled trial to evaluate the preliminary effectiveness of an adapted community health worker (CWH)-delivered positive affect counselling intervention delivered remotely via mHealth. The adapted intervention will include CHW-delivered positive affect skill-based counseling accessible through video call that will be accessible through the mHealth app. The CHW will conduct approximately 5 weekly individual 60-minute counseling sessions via a secure video call feature. If the participant does not have symptomatic improvement, the CHW will refer the participant to a licensed mental health professional. Participants will be randomized to receive access to the counselling intervention that also includes modified features of the mHealth app with increased mental health resources (intervention arm) or to current standard of mental health care that includes the unmodified version of the app (control arm). Participants allocated to the intervention arm will receive the counseling intervention approximately weekly for 5 weeks. The study will continue to abstract data from participants' EMR and mHealth app for approximately 6 months after enrollment. To assess preliminary effectiveness, the investigators will analyze differences by condition in anxiety and depression (primary outcome). Informed consent will be obtained prior to study participation.
RECRUITING
A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard. Control group will benefit from usual follow-up. All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.
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