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Design of a Hybrid Implementation Effectiveness Cluster Randomized Controlled Trial of Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings
IntroductionPosttraumatic stress disorder (PTSD) results in substantial costs to society. Prevalence of PTSD among adults is high, especially among those presenting to primary care settings. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination and implementation within primary care settings is challenging. Building Experience for Treating Trauma and Enhancing Resilience (BETTER) examines the effectiveness of integrating Written Exposure Therapy (WET) within primary care collaborative care management (CoCM). WET is a brief exposure-based treatment that has the potential to address many challenges of delivering PTSD EBPs within primary care settings.MethodsThe study is a hybrid implementation effectiveness cluster-randomized controlled trial in which 12 Federally Qualified Health Centers (FQHCs) will be randomized to either CoCM plus WET (CoCM+WET) or CoCM only with 60 patients within each FQHC. The primary aim is to evaluate the effectiveness of CoCM+WET to improve PTSD and depression symptom severity. Secondary treatment outcomes are mental and physical health functioning. The second study aim is to examine implementation of WET within FQHCs using FQHC process data and staff interviews pre- and post-intervention. Exploratory aims are to examine potential moderators and mediators of the intervention. Assessments occur at baseline, and 3- and 12-month follow-up.ConclusionThe study has the potential to impact practice and improve clinical and public health outcomes. By establishing the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care, the study aims to improve PTSD outcomes for underserved patients.
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Design of a Hybrid Implementation Effectiveness Cluster Randomized Controlled Trial of Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings
IntroductionPosttraumatic stress disorder (PTSD) results in substantial costs to society. Prevalence of PTSD among adults is high, especially among those presenting to primary care settings. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination and implementation within primary care settings is challenging. Building Experience for Treating Trauma and Enhancing Resilience (BETTER) examines the effectiveness of integrating Written Exposure Therapy (WET) within primary care collaborative care management (CoCM). WET is a brief exposure-based treatment that has the potential to address many challenges of delivering PTSD EBPs within primary care settings.MethodsThe study is a hybrid implementation effectiveness cluster-randomized controlled trial in which 12 Federally Qualified Health Centers (FQHCs) will be randomized to either CoCM plus WET (CoCM+WET) or CoCM only with 60 patients within each FQHC. The primary aim is to evaluate the effectiveness of CoCM+WET to improve PTSD and depression symptom severity. Secondary treatment outcomes are mental and physical health functioning. The second study aim is to examine implementation of WET within FQHCs using FQHC process data and staff interviews pre- and post-intervention. Exploratory aims are to examine potential moderators and mediators of the intervention. Assessments occur at baseline, and 3- and 12-month follow-up.ConclusionThe study has the potential to impact practice and improve clinical and public health outcomes. By establishing the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care, the study aims to improve PTSD outcomes for underserved patients. Read More Subscribe to the Policy Currents newsletter Email Subscribe Topics DepressionMental Health TreatmentPosttraumatic Stress DisorderPrimary CareRandomized Controlled TrialRegression Analysis Document Details Document Details Copyright: 兰德公司Publisher: Elsevier IncAvailability: Non-RAND Year: 2024 Pages: 8 Document Number: EP-70352 Research conducted by RAND Health Care This publication is part of the RAND external publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations. RAND is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.
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A Parish-Based Multilevel Cluster Randomized Controlled Trial to Reduce Stigma and Mental Health Treatment Disparities Among Latino Communities
Latino communities within the U.S. are disproportionately affected by persistent, high levels of untreated mental illness. Limited mental health literacy, stigma, and cultural factors are major contributors to Latino mental health treatment disparities. Although Latino individuals may be reluctant to seek out mental health professionals, they often rely on religious congregations when confronted with mental illness. However, religious congregations report major obstacles to collaborating with the mental health sector including the lack of mental health training, staffing, and resources. Strategic partnerships between religious congregations and community-based organizations can be leveraged to target sources of Latino mental health treatment disparities. The National Alliance on Mental Illness (NAMI), the nation's largest grassroots mental health organization, has developed a host of programs tailored to the different needs and segments of the community affected by mental illness, including programs designed to address culturally diverse and faith-based communities. This cluster-randomized controlled trial leverages the collective resources of NAMI and the Diocese of San Bernardino to deliver and evaluate the effectiveness of a multi-level, parish-based, intervention to decrease stigma, increase mental health literacy, and improve access to mental health services among Latino parishioners. This study will enroll 1400 participants from 14 parishes that will be randomly assigned to receive the intervention immediately or a wait-list control condition. The intervention could enrich awareness of mental health issues, shape norms about mental illness, facilitate treatment access, and add support from religious congregations to target Latino mental health disparities using culturally and faith-based tailored approaches.
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A Parish-Based Multilevel Cluster Randomized Controlled Trial to Reduce Stigma and Mental Health Treatment Disparities Among Latino Communities
Latino communities within the U.S. are disproportionately affected by persistent, high levels of untreated mental illness. Limited mental health literacy, stigma, and cultural factors are major contributors to Latino mental health treatment disparities. Although Latino individuals may be reluctant to seek out mental health professionals, they often rely on religious congregations when confronted with mental illness. However, religious congregations report major obstacles to collaborating with the mental health sector including the lack of mental health training, staffing, and resources. Strategic partnerships between religious congregations and community-based organizations can be leveraged to target sources of Latino mental health treatment disparities. The National Alliance on Mental Illness (NAMI), the nation's largest grassroots mental health organization, has developed a host of programs tailored to the different needs and segments of the community affected by mental illness, including programs designed to address culturally diverse and faith-based communities. This cluster-randomized controlled trial leverages the collective resources of NAMI and the Diocese of San Bernardino to deliver and evaluate the effectiveness of a multi-level, parish-based, intervention to decrease stigma, increase mental health literacy, and improve access to mental health services among Latino parishioners. This study will enroll 1400 participants from 14 parishes that will be randomly assigned to receive the intervention immediately or a wait-list control condition. The intervention could enrich awareness of mental health issues, shape norms about mental illness, facilitate treatment access, and add support from religious congregations to target Latino mental health disparities using culturally and faith-based tailored approaches.
智库成果
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A Parish-Based Multilevel Cluster Randomized Controlled Trial to Reduce Stigma and Mental Health Treatment Disparities Among Latino Communities
Latino communities within the U.S. are disproportionately affected by persistent, high levels of untreated mental illness. Limited mental health literacy, stigma, and cultural factors are major contributors to Latino mental health treatment disparities. Although Latino individuals may be reluctant to seek out mental health professionals, they often rely on religious congregations when confronted with mental illness. However, religious congregations report major obstacles to collaborating with the mental health sector including the lack of mental health training, staffing, and resources. Strategic partnerships between religious congregations and community-based organizations can be leveraged to target sources of Latino mental health treatment disparities. The National Alliance on Mental Illness (NAMI), the nation's largest grassroots mental health organization, has developed a host of programs tailored to the different needs and segments of the community affected by mental illness, including programs designed to address culturally diverse and faith-based communities. This cluster-randomized controlled trial leverages the collective resources of NAMI and the Diocese of San Bernardino to deliver and evaluate the effectiveness of a multi-level, parish-based, intervention to decrease stigma, increase mental health literacy, and improve access to mental health services among Latino parishioners. This study will enroll 1400 participants from 14 parishes that will be randomly assigned to receive the intervention immediately or a wait-list control condition. The intervention could enrich awareness of mental health issues, shape norms about mental illness, facilitate treatment access, and add support from religious congregations to target Latino mental health disparities using culturally and faith-based tailored approaches.
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Impact of Collaborative Care for Underserved Patients with PTSD in Primary Care: A Randomized Controlled Trial
BACKGROUND: The effectiveness of collaborative care of mental health problems is clear for depression and growing but mixed for anxiety disorders, including posttraumatic stress disorder (PTSD). We know little about whether collaborative care can be effective in settings that serve low-income patients such as Federally Qualified Health Centers (FQHCs). OBJECTIVE: We compared the effectiveness of minimally enhanced usual care (MEU) versus collaborative care for PTSD with a care manager (PCM). DESIGN: This was a multi-site patient randomized controlled trial of PTSD care improvement over 1 year. PARTICIPANTS: We recruited and enrolled 404 patients in six FQHCs from June 2010 to October 2012. Patients were eligible if they had a primary care appointment, no obvious physical or cognitive obstacles to participation, were age 18–65 years, planned to continue care at the study location for 1 year, and met criteria for a past month diagnosis of PTSD. MAIN MEASURES: The main outcomes were PTSD diagnosis and symptom severity (range, 0–136) based on the Clinician-Administered PTSD Scale (CAPS). Secondary outcomes were medication and counseling for mental health problems, and health-related quality of life assessed at baseline, 6 months, and 12 months. KEY RESULTS: Patients in both conditions improved similarly over the 1-year evaluation period. At 12 months, PTSD diagnoses had an absolute decrease of 56.7 % for PCM patients and 60.6 % for MEU patients. PTSD symptoms decreased by 26.8 and 24.2 points, respectively. MEU and PCM patients also did not differ in process of care outcomes or health-related quality of life. Patients who actually engaged in care management had mental health care visits that were 14 % higher (p < 0.01) and mental health medication prescription rates that were 15.2 % higher (p < 0.01) than patients with no engagement. CONCLUSIONS: A minimally enhanced usual care intervention was similarly effective as collaborative care for patients in FQHCs.
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Design of the Violence and Stress Assessment (ViStA) Study: A Randomized Controlled Trial of Care Management for PTSD Among Predominantly Latino Patients in Safety Net Health Centers
Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care.
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Randomized Controlled Trial of a Psychoeducational Video Intervention for Traumatic Injury Survivors
OBJECTIVE: This randomized controlled trial evaluated the impact of a psychoeducational video on posttraumatic distress and factors related to the mental health treatment seeking process among trauma care center patients receiving care following hospitalization for a serious physical injury. METHOD: Ninety-nine, predominantly Hispanic American (59%) and male (84%), participants were randomized to view either a psychoeducation intervention or a wound care control video. Participants were assessed at pre-intervention, post-intervention, and at 1-month follow-up on posttraumatic stress reactions, attitudes toward mental health service utilization, and knowledge and self-recognition of posttraumatic stress symptoms. RESULTS: Immediately after viewing the psychoeducational video, participants exhibited greater knowledge of PTSD symptoms and more positive beliefs about mental health treatment than those in the wound care condition. At 1-month follow-up, however, these differences were no longer maintained. Further, no significant differences in PTSD were found between the intervention and control groups. Differences in self-recognition of PTSD nearly reached significance with psychoeducation intervention participants being more likely to recognize their symptoms as mental health problems than control condition participants. CONCLUSION: Brief psychoeducation interventions for traumatic injury survivors may have had immediate modest effects on mental health literacy, beliefs about mental health treatment, and self-recognition of PTSD, but were not maintained at 1-month follow-up. More comprehensive and targeted interventions may be needed to facilitate more potent and long-lasting change.
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