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37 recruiting in MI
Recruiting

Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

Inherited Retinal Diseases

The purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss. The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.

Ann Arbor, MI18+ yrsAll genders
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Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Quality of Life · PTSD · Depression Not Otherwise Specified

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Ann Arbor, MI18+ yrsAll genders
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Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Generalized Anxiety Disorder (GAD) · Anxiety Disorders

This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.

Detroit, MI18–45 yrsAll genders
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Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Bipolar Depression

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Bloomfield Hills, MI10–17 yrsAll genders
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A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

Major Depressive Disorder

The goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel1)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Rochester Hills, MI18–64 yrsAll genders
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Recruiting

Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)

Depression

This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies. The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. It is hypothesized that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, treatment moderators will be explored and a cost-effectiveness analysis will be conducted to assess the economic viability of the intervention. The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Causal mediation analysis will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis. The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.

Ann Arbor, MI50+ yrsAll genders
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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Systemic Lupus Erythematosus of Childhood (Disorder)

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

Grand Rapids, MI12–22 yrsAll genders
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Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Anxiety · Social Anxiety Disorder · Panic Disorder

This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback. The study hypotheses include: * Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF * Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF * PFC activation will positively correlate with CR ability

Ann Arbor, MI18–24 yrsAll genders
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Recruiting

Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

Depression · Anterior Cruciate Ligament Injuries · Mental Health Issue

The goal of this parallel arm prospective randomized control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care. The main question the investigators are asking is if virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. The investigators hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls.

Detroit, MI13+ yrsAll genders
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Recruiting

PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study

Depression

The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: * How well the treatment helps with symptoms of depression (effectiveness), * How comfortable and willing people are to use the treatment (acceptability), and * How well people can deal with any side effects from the treatment (tolerability). The study will also examine factors that may predict which treatment works better for certain patients.

Ann Arbor, MI18+ yrsAll genders
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Recruiting

Family Acceptance Project Online (Pilot RCT)

LGBTQ · Racial Disparities · Family Relationships

Research shows that sexual and gender minority youth (SGMY) experience high rates of mental health problems and other challenges (e.g., social, academic). A major factor that leads to these challenges is family rejection (family behaviors and reactions that minimize, deny, ridicule and attempt to prevent or change a child's sexual orientation, gender identity and gender expression). Racial and ethnic minority youth experience the highest rates of family rejection and related health risks. The Family Acceptance Project (FAP) is a research, education, and intervention initiative that was founded more than 20 years ago to help diverse families learn to support and affirm their SGMY. FAP's Family Support Model is grounded in the lived experiences of diverse SGMY and families and uses a culture-based family support framework that enables parents and caregivers to change rejecting behaviors that FAP's research has shown contribute to health risks and increase supportive and accepting behaviors that promote well-being for SGMY. The overall goal of this research project is to evaluate a nine-week online version of FAP's Family Support Model (FAP-O). The investigators will specifically study how FAP-O: 1. Promotes parent/caregiver acceptance and support of their sexual and gender minority youth. 2. Increases family bonding and communication. 3. Increases SGMYs' feelings of pride in being LGBTQ+ and more hopeful about the future. 4. Leads to reductions in mental health problems reported by SGMY who experience family rejection. Before receiving FAP-O's family support services, racial and ethnic minority SGMY (ages 14 to 25) and their caregivers will complete an initial pre-test survey. After completing this initial (baseline) survey, half of the families will participate in program sessions. Following the first round of sessions, all participants will complete an immediate follow-up survey, with an additional survey conducted six months after this. These surveys help us learn if FAP-O impacts the project's goals above. After the final survey, the other half of the families will attend program sessions. The investigators will also ask SGMY and caregivers to share what they liked about the program and their guidance for enhancing it.

Ann Arbor, MI14+ yrsAll genders
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Recruiting

Support for Bereaved Cancer Caregivers

Bereavement · Cancer · Caregiver

Friend and family caregivers of recently deceased cancer patients experience acute bereavement following the death. Post death bereavement is an intense period of mourning that includes an unfolding of the grief process and is characterized by strong emotions and demands on cognitive resources to those who have put aside their own needs to support the dying patient with cancer. This research will test the feasibility and acceptability of a nature-based healing meditation (NBHM) intervention to support cancer caregivers' during the bereavement process.

East Lansing, MI18+ yrsAll genders
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Recruiting

Peer-Delivered Behavioral Activation in a CCBHC

Major Depressive Disorder · Substance Use Disorders

Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and/or substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) among individuals receiving services from a community-based treatment setting providing integrated physical and behavioral healthcare.

Detroit, MI18+ yrsAll genders
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Family Spirit Strengths

Depressive Symptoms · Anxiety Disorders and Symptoms · Substance Use

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

Pokagon, MI14+ yrsWomen
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Sleep to Reduce Incident Depression Effectively in Peripartum

Insomnia · Depression

Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.

Novi, MI18+ yrsWomen
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Recruiting

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

Generalized Anxiety Disorder

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Ann Arbor, MIAll agesAll genders
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