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Engagement, Patient clinical trials

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NCT ID: NCT05922670 Active, not recruiting - Suicide Clinical Trials

The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth

Start date: August 24, 2022
Phase: N/A
Study type: Interventional

Suicide is the second leading cause of death for 15-to-24-year-olds in the United States. Compared to their heterosexual and cisgender peers, sexual and gender minority (SGM) adolescents report significantly higher rates of suicidal ideation and suicide attempts. Unfortunately, many barriers complicate the implementation of suicide prevention in SGM communities. SGM youth often report feeling unwelcome and misunderstood in traditional behavioral health service organizations. Consequently, treatment attendance and retention remain low. Instead, this population generally seeks mental health services in community organizations for lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth. Unfortunately, these organizations are often unprepared for this clinical challenge. The Behavioral Health-Works (BH-Works) suicide risk management system may offer a potential solution to this problem. BH-Works is an evidence-based, comprehensive youth suicide prevention program. It offers support for policy development, staff training, suicide and behavioral health screening, technology-assisted safety planning, an electronic patient referral system, real-time data analytics for program monitoring, and a learning collaborative structure to support sustainability. All functions are supported on a web-based software platform that facilitates cross-system communication, implementation, adoption, and expansion. In this project, the investigators will adapt this program for LGBTQ organizations and test feasibility, acceptability and preliminary effectiveness. This project builds upon robust partnerships with two diverse LGBTQ organizations in Philadelphia, Pennsylvania and rural Southwest, Virginia) and their respective behavioral health (BH) partnering sites. To facilitate BH-Works adaptation for SGM adolescents, the investigators will employ the Enhancing Engagement trajectory from Lau's cultural adaptation framework. To pilot the program within LGBTQ organizations and their partners, the investigators will use an Effectiveness-Implementation Hybrid Type 2 design with a historical comparison group. Informed by the Consolidated Framework for Implementation Research, the investigators will also pilot test a sequenced implementation strategy. This strategy focuses on promoting engagement, building partnerships, and creating sustainability. In Years 1 and 2, the investigators will collect treatment as usual data, and work with their partners to adapt BH-Works policy, content, practices, and workflow. The investigators will also train staff/providers in suicide risk management, family engagement and affirmative care. In Years 3 and 4, the investigators will test the adapted SGM BH-Works Program and examine several essential program targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification). The proposed research responds to the growing national need to identify and refer vulnerable youth at risk for suicide. A future R01 will examine SGM BH-Works program effectiveness with partnering LGBTQ and BH sites across the nation.

NCT ID: NCT04583891 Active, not recruiting - Depression, Anxiety Clinical Trials

Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).

NCT ID: NCT04507360 Active, not recruiting - Engagement, Patient Clinical Trials

Enhancing Engagement With Digital Mental Health Care

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

This proposal is a partnership between Mental Health America (MHA), a nonprofit mental health advocacy and resource organization, Talkspace (TS), a for-profit, online digital psychotherapy organization, and the University of Washington's Schools of Medicine and Computer Science Engineering (UW). The purpose of this partnership is to create a digital mental health research platform leveraging MHA and TS's marketing platforms and consumer base to describe the characteristics of optimal engagement with digital mental health treatment, and to identify effective, personalized methods to enhance motivation to engage in digital mental health treatment in order to improve mental health outcomes. These aims will be met by identifying and following at least 100,000 MHA and TS consumers over the next 4 years, apply machine learning approaches to characterizing client engagement subtypes, and apply micro-randomized trials to study the effectiveness of motivational enhancement strategies and response to digital mental health treatment.

NCT ID: NCT04000971 Active, not recruiting - Stroke Clinical Trials

Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

C3FIT
Start date: February 25, 2020
Phase: N/A
Study type: Interventional

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health. Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost. Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.