378 Clinical Trials for Various Conditions
This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.
The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are: * What are differences between depressed and non-depressed participants on baseline neural and parenting indicators? * Do baseline neural and parenting indicators predict response to FFT-CD? * Does change in parenting and neural functioning mediate change in depression from baseline to follow-up? Participants will: * complete baseline clinical measures * complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR) * undergo a 12-session course of FFT-CD * complete follow up evaluations and neuroimaging
The purposes of this study are to test among adolescent viewers the utility of different types of selfie short video-based messaging to: 1. Reduce stigma and self-stigma related to depression, and 2. Increase treatment-seeking intentions.
Despite experiencing higher rates of depressive symptoms (Center for Disease Control and Prevention, 2020) and similar rates of Major Depressive Disorder (MDD; Substance Abuse and Mental Health Services Administration (SAMHSA), 2019), Latino adolescents in the U.S. are significantly less likely than their non-Latino White peers to receive treatment for MDD (SAMHSA, 2019). The purpose of this study is to identify a stakeholder-preferred implementation strategy that may improve psychotherapy attendance among Latino adolescents. Latino adolescent-parent dyads and healthcare providers will be recruited from healthcare settings and social media. Focus groups will be conducted with healthcare providers (n=5), and individual interviews will be conducted with Latino adolescents with a diagnosis of depression (n=15) and their parents (n=15).
The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.
Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.
Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.
We will recruit 216 subjects meeting the eligibility criteria. After completing a baseline battery session via secure video conferencing and 3-week phone survey period, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. This second session for the intervention will take place within 2-3 weeks after the phone survey period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires to index shifts in proximal outcomes. Participants, both adult and youth, will complete additional follow-up questionnaires 3, 6, 12, 18, and 24 months post-intervention. Participants will complete the intervention, including the pre- and post- SSI questionnaires, and follow-up surveys on their own.
The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).
Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).
A novel web-based module (Teen Depression Module or TDM)has been created for assisting primary care providers (PCPs) in screening for and addressing and referring teens with depression. This is a cluster randomized Quality Improvement study to determine if use of the TDM that includes collecting information on strengths and goals as part of well child care will improve detection of depression, referral success, and teen's use of alternative helping strategies with resulting improvement in depression symptoms.
This is an open label, pilot, feasibility study evaluating effects of Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) on 5 eligible adolescents for the treatment of depression. Safety and tolerability will be evaluated with changes in depression scores, and suicidality and non-suicidal self injurious behavior will also be monitored for exploratory and safety measures.
Depression, the most common mental health disorder among adolescents, is a critical health problem within the US. In this study, the feasibility, acceptability, and preliminary efficacy of Limbix Spark, a cognitive behavioral therapy (CBT)- based mobile app + virtual reality (VR) program for helping adolescents live well with depression will be investigated. This program is specifically designed around behavioral activation theory, the idea that completing activities that make a patient feel pleasure or provide a sense of mastery are effective in reducing symptoms of depression. The program involves the use of both VR and a mobile app that include CBT components like psychological assessments, psychoeducation, and skills training. 30 participants aged 12-21 years old with mild to severe depressive symptoms and smartphone access will be enrolled in this study. The primary efficacy outcome measures will be depressive symptoms with anxiety symptoms, functional outcomes, and dimensional scales of positive and negative affect and behavioral activation serving as secondary outcome measures. Qualitative and quantitative feedback on the use of the VR + mobile app (ease of use, comfort, willingness to use again) will be assessed using questionnaires. Engagement and adherence to the program will be assessed by assessing VR and app usage.
Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. The purpose of this study is to identify facilitators of and barriers to depression treatment engagement among Latina adolescents across patient-, family-, and healthcare provider-levels from the perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers will be recruited from community and healthcare settings. Separate individual semi-structured interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two focus groups will be conducted with primary care providers (n=6) and mental health providers (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to analyze the transcripts to determine common themes in facilitators and barriers across stakeholder groups.
The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6 infusions of midazolam in 24 adolescents with treatment resistant depression. The primary outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The second phase is a 6-month open phase in which patients who received midazolam and remain depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All participants will be followed weekly for 6 months and tracked for time to relapse.
This study will evaluate whether a newer treatment, rumination-focused cognitive behavioral treatment, which includes mindfulness and can be used to reduce ruminative habits, change ways in which key brain regions interact with each other (e.g.., often called connectivity), and whether these changes in habits and brain connectivity can reduce the risk for recurrence of depression in the next two years.
This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses. This outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication. The study begins with an evaluation that includes clinical assessment, interviews, and questionnaires. * Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment. * Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based "talk" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging. All clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research. The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH.
The Researchers are going to gather information regarding the use of rTMS as a treatment for depression in adolescents with Major Depressive Disorder. The researchers also hope to learn if measures of brain activity (cortical excitability and inhibition) collected with transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit from certain types of rTMS treatment.
The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.
This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation intensities using a 3+3 study design for safety and tolerability amongst adolescents. This means that we will only enroll 3 participants at a time and give them rTMS at the stimulation intensity energy of 80% of motor threshold (MT). If all three participants complete the 6 weeks of treatment with no major safety events (i.e. seizure), we will increase the energy for the next 3 participants by 20%. If 1 of the 3 participants has a major safety event, we will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by 20% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of motor threshold. If 2 participants in each intensity level cohort experience a major safety event, we will discontinue running subjects at that energy level. If this happens at our initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the higher energy cohorts, we will return to the previous energy level and complete the remainder of the subjects at that energy level.
The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).
The purpose of this study is to learn if measures of brain chemicals from a brain scan called Magnetic Resonance Imaging and Spectroscopy (MRI/MRS) and brain activity (known as cortical excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are different in adolescents with depression who are in different stages of treatment. Researchers are conducting this study to learn more about how the brain works in adolescents with depression and without depression (healthy controls). This is important because it may identify a biological marker (a measure of how bad an illness is) for depression that could one day be used to identify depressed adolescents who would benefit from certain treatments (medications for example) or to monitor how well treatments are working.
This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.
The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking in high school students. The ADAP intervention will be carried out in approximately 60 schools with over 15,000 students. The following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.
Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy. Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment. Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
The goal of this study is to examine the use of new technologies in disseminating and improving CBT treatment for adolescent depression. An on-line therapist training tutorial will be followed by 12 weeks of CBT treatment according to the training protocol. CBT treatment will be augmented with the use of automated text messages for homework reminders and reinforcement of learning. In session patient education and review of CBT concepts will be augmented through teaching materials delivered via iPad. 16 therapists will be recruited, each treating 4 depressed adolescents. Half the therapists will be randomly assigned to TAU, followed by the training intervention. Automated patient outcomes measures will be examined.
The purpose of the study is: 1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and 2. to compare two ways of providing treatment to teenagers who have not improved enough.
This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.
The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment. This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.