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38 recruiting in MI
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Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

Major Depressive Disorder

The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms. This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.

Ann Arbor, MI18–55 yrsAll genders
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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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E-Mindfulness Approaches for Living After Breast Cancer

Breast Cancer · Depression

NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Alma, Alpena +more, MI18–50 yrsAll genders
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Evaluating Screening Adherence Between Moment for Parents App and Attention Control

Mental Health Screening Adherence

Mental health challenges, such as depression and anxiety, are the most common medical complications during pregnancy and after childbirth. Many women experience these symptoms, yet half are never screened, let alone diagnosed. When mental health concerns go unnoticed, they can affect a mother's well-being, her birth experience, and her child's development. When identified early, these conditions are treatable. However, current healthcare practices often fail to screen women consistently, and many women do not feel comfortable discussing emotional struggles with healthcare providers. This study will test whether a mobile app called Moment for Parents can help pregnant and postpartum women complete mental health screenings more regularly. The app includes educational articles, guided reflections, and mood check-ins that help women explore their feelings in a private, supportive environment. The app also includes a chatbot that guides them through short lessons about motherhood, stress, relationships, and emotional well-being. These conversations are designed to feel friendly and relatable, like talking with a knowledgeable companion rather than filling out a medical form. The investigators expect that this more personal experience may make it easier for women to notice and track changes in their mental health and encourage them to complete regular screeners. The study will enroll 160 women who are pregnant or within the first year after giving birth. Participants will be randomly assigned to one of two groups: Intervention group: Uses the full Moment for Parents app, including the interactive chatbot. Control group: Uses a simplified version of the app with weekly articles but no chatbot. Both groups will receive mental health screenings through the app over a 12-week period. These screenings include standard, widely used questionnaires that measure symptoms of depression and anxiety. If a participant's answers show signs of concerning symptoms, such as depression, anxiety, or thoughts of self-harm, the study team will connect her to licensed mental health professionals for support. This offers more rapid help than the current standard of care, which often screens women only once during pregnancy. The investigators hypothesize that women who interact with the chatbot version of the Moment for Parents app will complete mental health screenings twice as often as women using the app without the chatbot. In other words, the investigators believe the chatbot will increase regular screening by creating a more engaging and supportive experience. Increasing the number of completed mental health screenings could help identify emotional struggles earlier, when treatment is most effective. If this study shows that the Moment for Parents app improves screening and engagement, it could guide the design of a larger study and help shape future care for pregnant and postpartum women nationwide. Overall, this research aims to make mental health support more accessible, less stigmatizing, and easier to use.

Ann Arbor, MI18+ yrsWomen
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Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Suicidal Ideation · Major Depressive Disorder · Schizo Affective Disorder

This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Grand Rapids, MI18–90 yrsAll genders
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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, MI18+ yrsAll genders
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Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients

Progressive Multiple Sclerosis · Depression

This trial explores the use of immersive virtual reality (VR) nature-based experiences as a supplementary treatment for depression in individuals with progressive multiple sclerosis (MS). This study will evaluate the feasibility and efficacy of at-home VR deployment using the Apple Vision Pro, an advanced device that offers enhanced resolution, immersion, and usability compared to earlier VR systems. The study hypotheses include: * The integration of VR nature-based experiences with standard care will be feasible, acceptable, and will result in greater reductions in depressive symptoms compared to standard care or VR-only interventions. * The integration of VR nature-based experiences with standard care will result in greater reductions in stress and anxiety, better sleep, less insomnia, and improved fatigue compared to standard care alone or VR-only interventions.

Ann Arbor, MI18+ yrsAll genders
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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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The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

Postpartum Depression

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

Flint, MI18+ yrsWomen
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Treatment Resistant Depression

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Ann Arbor, 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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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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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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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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Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures

Situational Anxiety · Behavior

Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.

Ann Arbor, MI4–12 yrsAll genders
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Virtual Reality (VR) NATURE - Alcohol Use Disorder (AUD)

Alcohol Use Disorder

This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effectiveness of immersive Virtual Reality (VR) nature intervention among adults with at least moderate depression symptoms enrolled in an intensive outpatient Program (IOP) for Alcohol Use Disorder (AUD). The study hypotheses: * VR-based nature immersion will be feasible, acceptable, and positively evaluated by participants * Participants receiving the VR intervention will report greater reductions in symptoms of depression, anxiety, and stress compared to those receiving standard care alone

Ann Arbor, MI18+ yrsAll genders
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