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38 recruiting in CO
Recruiting

Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery

Anxiety in Pregnancy ยท Mood Disorder Due to Specified Medical Condition

Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma symptoms (PMATS). There is a deficit in resources and access to mental health treatment for pregnant patients, with some treatments being cost-prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to trauma. The investigators developed a low-cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. To revise the implementation plan and intervention (CARE: Communication, Agency, Readiness, Empowerment for cesarean delivery \[CD\]) for use in large L\&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Before initiating such a trial, work needs to be done to modify the intervention and implementation through a process of iterative refinement to enhance the acceptability, appropriateness, and feasibility of implementation in L\&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, and hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a steering council. Following this refinement process, a treatment development pilot RCT at a large L\&D unit will assess the efficacy of CARE for CD by probing engagement with the target mechanism, as well as assess the feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council.

Aurora, COAll agesWomen
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Parenting Skills Group for Mothers With Postpartum Depression

Postpartum Depression

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: * Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? * Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? * Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will * Participate in an 8-week COSP program delivered remotely via Zoom. * Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. * Complete a series of assessment questionnaires delivered remotely. * Videotape a play-based assessment in their home. * Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

Denver, CO18โ€“50 yrsWomen
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Recruiting

Investigation to Understand and Optimize Psilocybin

Depression

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Edwards, CO18โ€“70 yrsAll genders
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Recruiting

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.

Denver, CO18โ€“65 yrsAll genders
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Recruiting

Improving Maternal Sleep and Mental Health

Postpartum Depression ยท Postpartum Anxiety ยท Sleep Disturbance

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.

Colorado Springs, CO18โ€“45 yrsWomen
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Recruiting

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Depressive Disorder, Major

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Denver, CO18โ€“74 yrsAll genders
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Recruiting

Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes

Type 1 Diabetes (T1D)

Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.

Aurora, CO13โ€“17 yrsAll genders
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Recruiting

Cannabis for Palliative Care in Cancer

Sleep ยท Anxiety ยท Depression

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

Aurora, CO25+ yrsAll genders
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Recruiting

The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home

Perinatal Mental Health

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

Aurora, COAll agesAll genders
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Recruiting

Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

Major Depressive Disorder ยท Mild Neurocognitive Disorder ยท HIV

A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.

Aurora, CO18โ€“70 yrsAll genders
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Recruiting

Modulating Exercise Dosage to Improve Concussion Recovery

Concussion, Brain ยท Treatment ยท Aerobic Exercise

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

Aurora, CO13โ€“18 yrsAll genders
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Recruiting

Creative Arts Program to Reduce Burnout in Healthcare Professionals

Burn-Out Syndrome ยท Post-Traumatic Stress Disorder ยท Depression, Anxiety

This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.

Aurora, CO18โ€“85 yrsAll genders
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Recruiting

ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Major Depressive Disorder (MDD) ยท Depressive Disorder, Treatment-Resistant

The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? * What adverse events do participants have when taking ACP-211?

Denver, CO18โ€“65 yrsAll genders
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