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87 recruiting in PA
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Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms

Acoustic Stimulation

In this study, the investigators will recruit young adults (ages 18-25 years) with elevated anxiety/depression symptoms and sleep disturbance. Participants will complete two overnights in a sleep lab. During one of the overnights, slow-wave activity will be enhanced by delivering sub-arousal auditory tones during slow-wave sleep using a headband device (Philips SmartSleep or Dreem 2). During the other overnight, tones will not be administered. Cognitive and emotional processes will be evaluated using behavioral task performance, self-report, and functional magnetic resonance imaging (fMRI). After the second overnight, participants will take the headband device home and wear it every night for approximately 2 weeks. For half of the participants, the headband will play tones every night and, for the other half, the headband will not play tones. Participants will then return for a final testing visit in which cognitive and emotional processes and anxiety/depression symptoms will be assessed using behavioral task performance and self-report.

Pittsburgh, PA18โ€“25 yrsAll genders
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Caregiver Stress and Sleep Study

Depressive Symptoms ยท Caregiver Burden

The purpose of this research study is to better understand how stress, sleep and activity might impact caregivers' mood and brain health. This study includes a randomized experimental component where therapists will systematically deliver one of two evidence-based talk-therapy treatments. The aim is to evaluate effects on meaningful health-relevant measures including morning activation levels, depression symptoms, rumination, and aspects brain connectivity previously linked with depression. Participants will complete surveys about their caregiving experiences, health, and mood, undergo an MRI, and wear an actigraphy watch that measures activity levels throughout the day and when sleeping.

Pittsburgh, PA55+ yrsAll genders
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Brief Smartphone Treatment Study

Generalized Anxiety Disorder

Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.

University Park, PA18+ yrsAll genders
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Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

Major Depression ยท Late Life Depression (LLD)

The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD). This is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison. Depression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.

Pittsburgh, PA65+ yrsAll genders
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Teen Brain Online II: Understanding How Social Media Affects the Teen Brain

Depression

There has been much interest in the potential role of social media (SM) use in driving a current mental health crisis among teens, with a dire need for evidence that goes beyond self-report. One important avenue is to understand the role of the brain in driving the effects of SM use on emotional health and vice versa. However, there is almost no research addressing these questions, largely due to a lack of tasks that can probe the neural correlates of modern SM use. The goal of this clinical trial is to develop and validate a new developmentally-appropriate and ecologically-valid functional magnetic resonance imaging (fMRI) and eyetracking task, the TeenBrainOnline (TBO) Task, that is more realistic and similar to modern SM platforms. Participants will be 50 teens (ages 13-17) with depressive symptoms who will complete the final version of TBO task during fMRI with eye-tracking, an older Chatroom Interact (CHAT-I) Task, daily surveys of SM use, and measures of depressive symptoms. Our goal is to show that the task works by: * Demonstrating that it activates expected regions of the brain and visual attention biases toward feedback cues. * Showing that brain and eyetracking (visual attention) activity on the task explain variability in depressive symptoms at baseline and three months later, and work better than similar indices from an older task. * Showing that brain and eyetracking (visual attention) activity on the task are associated with real-world measures of social media use collected during daily surveys. Specifically, The investigators expect that teens whose brain and eyetracking activity suggests they are more sensitive to feedback on SM will report a social evaluation orientation toward social media use in daily life, such as engaging a lot in social comparison, worrying about missing out, and caring about getting a lot of likes and comments. Participants will be asked to: * complete a 10-15 minute screening call to determine eligibility for the study * complete one 90 minute virtual study visit to complete questionnaires and prepare for the MRI visit (visit 1) * submit 24 photos to our study specific social media site * complete an (in person) MRI scan visit (\~4 hours), which consists of 2 tasks where they will interact with peers (visit 2) * complete \~5 minute smartphone surveys 3 times a day for 16 days, asking about their daily experiences online and emotional reactions. * complete 2 online questionnaires asynchronously 3 months after their scan date

Pittsburgh, PA13โ€“17 yrsAll genders
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Decoding and Modulating Affective Brain States

Rumination ยท Major Depressive Disorder ยท Anxiety

The research study is being conducted to study brain patterns of negative emotion and develop personalized brain stimulation protocols to disrupt these patterns with transcranial magnetic stimulation (TMS). First, the investigators will use functional Magnetic Resonance Imaging (fMRI) data to generate a negative affect map for each participant. Then, the investigators will apply a variety of repetitive transcranial magnetic stimulation (rTMS) sequences while the participant is inside the MRI scanner to determine the optimal and least optimal rTMS frequencies at changing negative affect brain states. Finally, these two frequencies will be tested over two 3-day rTMS neuromodulation sessions to assess whether they can reduce negative emotions.

Philadelphia, PA18โ€“65 yrsAll genders
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A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder

Social Anxiety Disorder

This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 ยตg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 ยตg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.

Plymouth Meeting, PA18โ€“65 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.

Allentown, Moosic +more, PA18โ€“64 yrsAll genders
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Preoperative Opioid Tapering Before Spine Surgery

Opioid Consumption, Postoperative ยท Pain After Surgery ยท Opioid Dependency

This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.

Philadephia, PA18+ yrsAll genders
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Parent Encouragement And Coaching of Happiness in Youth

Depression ยท Parent-Child Relations

The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are: Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children. Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time. Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment. Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.

Pittsburgh, PA4โ€“99 yrsAll genders
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Recruiting

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

Generalized Anxiety Disorder

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

Media, PA18+ yrsAll genders
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A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

Treatment Resistant Depression

This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Moosic, Philadelphia, PA18โ€“65 yrsAll genders
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Neurofeedback to Treat Depression - 2

Major Depressive Disorder (MDD)

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

Philadelphia, PA18โ€“65 yrsAll genders
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Postpartum Care in the NICU (PeliCaN) Transitions

Stress Disorders, Post-Traumatic ยท Premature Birth ยท Postpartum Depression

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Philadelphia, PA16+ yrsWomen
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Foundational Programs to Combat Clinician Stress

Burnout, Professional ยท Stress, Psychological ยท Stress, Physiological

This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.

Lancaster, Philadelphia +more, PA25โ€“70 yrsAll genders
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