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167 Mental Health Trials Near You
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Fasedienol Nasal Spray for Social Anxiety
Chicago, Illinois
This Phase 3 clinical trial is designed to evaluate the Fasedienol Nasal Spray (fasedienol) for adults that are 18-65 who suffer from symptoms of social anxiety such as nervousness, worry or fear of judgement.
In addition, there is an Open Label Extension phase of the study for patients that choose to participate where use of nasal spray for up to 12 months will be assessed.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Alcohol Use, Others
Must Not Be Taking:Psychotropics, CBD, Herbal
236 Participants Needed
Peer Navigation for Psychiatric Disabilities
Chicago, Illinois
Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system.
Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity.
The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Peer Support, ACT Services, Others
354 Participants Needed
This trial tests AFFIRM, a group program for LGBTQ+ youth. It uses CBT techniques to help them manage stress, change negative thoughts, and build supportive social networks.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:14 - 29
Key Eligibility Criteria
Disqualifiers:High Suicidality Risk, Others
300 Participants Needed
e-Learning for Anxiety and Depression
Hamilton, Ontario
In this proposal, the investigators plan to study the impact of In this proposal, we plan to study the impact of e-learning on mental health literacy and stigma related to anxiety and depression. Participants will be randomized to one of four groups - Depression e-Learning A, Depression e-Learning B, Anxiety e-Learning A, and Anxiety e-Learning B. All participants will be given access to all e-learning at the conclusion of the study.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45+
Key Eligibility Criteria
Disqualifiers:Lives Outside Canada, Others
125 Participants Needed
This trial tests a program called Emotion Focused Family Therapy (EFFT) that helps parents support their children's emotional and behavioral development. It targets families with children needing emotional and behavioral support. The therapy aims to improve family relationships and maintain these improvements over time. Emotion-focused family therapy (EFFT) involves parents in their child's recovery from various mental health issues, including eating disorders.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 15
Key Eligibility Criteria
Disqualifiers:Severe Mental Health Disorders, Others
200 Participants Needed
Brief Behavioral Activation Treatment for Postpartum Depression
Evanston, Illinois
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
1230 Participants Needed
Parenting Program for Adolescent Health
Buffalo, New York
This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12+
1440 Participants Needed
Smoking Cessation App for Mental Health Disorders
Buffalo, New York
This trial will test a new smartphone app called Quit on the Go, designed to help people with serious mental illness quit smoking. The study will compare this app to traditional methods, with both groups also using nicotine patches and gum. The goal is to see if the app helps more people quit smoking and if it is cost-effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Acute Psychosis, Pregnancy, Others
450 Participants Needed
Civic Engagement Intervention for Mental Health Wellness
Winston-Salem, North Carolina
The purpose of this research is to understand how participating or not participating in an action civics curriculum may affect the health and wellbeing of young people. Participants will be chosen from students who attend certain schools that choose to participate in the action civics curriculum. Participation in this research involves completing surveys during class time in the Spring and Fall 2021-2022 semesters and then completing online surveys outside of class in the future.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 20
2500 Participants Needed
Va Meh Du for Mental Health
Winston-Salem, North Carolina
The goal of this clinical trial is to learn if a soccer program focused on mental health positively impacts mental health in Karenni refugee young boys and men. The main questions it aims to answer are:
Does mental health education provided during a sports program improve mental health coping for Karenni refugee young boys and men? Does participation in a sports-program improve social connection for Karenni refugee young boys and men?
Researchers will compare those receiving mental health education to a comparison group to see if mental health education improves mental health coping skills.
Participants will:
Participate weekly soccer practices for 6 months Receive mental health education or comparison activities Answer questions about their health, such as their coping skills, social connection, and physical activity
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Criminal Record, Others
60 Participants Needed
Focusing on seniors with mental health conditions who are living in the community, this initiative proposes to assess the acute and long-term effects of an 8-week course of daily (5 days/week) cognitive remediation (CR) training among 270 participants living in five LOFT senior housing units. The acute course of CR will be followed by monthly one-week boosters until the end of this 5-year study, totaling approximately 24-60 months of follow-up. This trial will also be used as a platform to explore the ability to use transcranial direct current stimulation (tDCS) to optimize response to CR by participant randomization to active versus sham tDCS. Our ultimate goal is to improve the lives of seniors experiencing mental illness and shape a future where they can live independently.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Active Substance Use, ECT, Cognitive Impairment, Others
18 Participants Needed
Exercise for Student Mental Health
Toronto, Ontario
Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.
Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:
* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?
* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?
Trial participants will be randomly assigned to one of the following groups:
1. 1:1 physical activity training;
2. Group-based physical activity training consisting of small 5-8 person groups; or
3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.
The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Physically Active, Unsuccessful Exercise Clearance, Others
93 Participants Needed
Mindful Parenting for Reducing Stress
Fairfax, Virginia
This trial is testing two programs for highly stressed parents of early adolescents. One program teaches mindfulness to help parents stay calm, while the other provides general parenting tips. The goal is to see which program better reduces stress and improves parenting.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 14
Key Eligibility Criteria
Disqualifiers:Intellectual Disability, Psychosis, Suicidality, SUDs, Others
269 Participants Needed
Stigma-Reduction Intervention for HIV Prevention
Fairfax, Virginia
The goal of the proposed research is to design a peer-based community intervention focused on addressing internalized homophobia, internalized racism, HIV stigma, and peer BSMM support to increase PrEP initiation among BSMM in Prince George's County, MD. Participants will attend intervention events focused on stigma reduction and building community among Black queer men. Researchers will compare intervention and control group participants to see if there in a difference in PrEP initiation and adherence.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:HIV Positive, Refusal Of HIV Testing
Must Be Taking:PrEP
120 Participants Needed
Resource Navigators for Caregiver Burnout
Toronto, Ontario
The goal of this clinical trial is to test how well resource navigators help long-term care and retirement home staff access the various health and wellness resources available to them and the effects that this has on their health and wellness overall. The main questions it aims to answer are:
- How does one-on-one support from a resource navigator affect the wellness of long-term care and retirement home staff, including burnout, vaccination status, and COVID-19 infection? Researchers will compare participants in the intervention group (where participants are paired with a resource navigator) and the control group (where participants are not paired with a resource navigator) to see the impact access to a resource navigator has on wellness (primary outcome), burnout, knowledge of, access to and use of wellness resources, knowledge/alignment with provincial public health guidelines related to SARS-CoV-2 vaccine outcomes, SARS-CoV-2 infection, hospitalization, and death (secondary outcomes).
Hypothesis: Researchers anticipate that those in the intervention group (have access to a resource navigator) will report a higher positive change in wellness between baseline and 6 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
174 Participants Needed
Text Messaging Support for Psychosis Transition Care
Toronto, Ontario
Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 29
Key Eligibility Criteria
Disqualifiers:Inability To Communicate In English
186 Participants Needed
This trial tests a new way of providing mental health and addiction services for young people aged 14-18. The Integrated Collaborative Care Team (ICCT) model involves a team of healthcare providers working together to offer fast and personalized care. The goal is to improve mental health outcomes, reduce waiting times, and be more cost-effective compared to usual treatments.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:14 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
247 Participants Needed
Narrative Enhancement and Cognitive Therapy for Bipolar Disorder
Toronto, Ontario
The goal of this pilot clinical trial is to assess the feasibility of conducting a full-scale study to learn if a new youth-adapted Narrative Enhancement and Cognitive Therapy (NECT-Y) reduces self-stigma in youth living with bipolar disorder or multiple mental health conditions. The main questions it aims to answer are:
* What is the feasibility of conducting a definitive clinical trial in terms of recruitment success, study retention/compliance, treatment retention/compliance, and absence of serious adverse events?
* Can facilitators deliver the adapted NECT-Y intervention with fidelity?
* What is the acceptability of the newly adapted NECT-Y intervention among youth participants and facilitators?
Researchers will compare NECT-Y to treatment as usual (TAU).
Participants will take part in a virtual 14-week NECT-Y group intervention or receive TAU. They will also complete questionnaires at three time points (baseline, post-treatment, and follow-up).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 29
Key Eligibility Criteria
Disqualifiers:Recent Hospitalization, New Psychotherapy, Communication Issues
96 Participants Needed
Group Psychotherapy for Mental Health after Amputation
Toronto, Ontario
People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poorer quality of life. To proactively address the mental health needs of this population, St. John's Rehab recruited two psychiatrists to provide mental health support to their inpatient population groups. Because there are limits to mental health resources and because group therapy facilitates patients learning from each other, the investigators plan to test an innovative psychological group therapy program designed for limb loss inpatients to address mental health challenges, and to better prepare them to integrate back into the community. Our designed psychosocial group therapy is led by a psychiatrist and an occupational therapist who create a structured process for inpatients to discuss their challenges and identify coping strategies that will help them transition back into the community. The investigators will recruit 130 inpatients with limb loss, with 65 taking part in a weekly psychosocial group therapy program and 65 receiving treatment as usual. The investigators will evaluate if anxiety and depression significantly decreases in our treatment group compared to those who received treatment as usual. The findings of this work will provide needed evidence for the clinical feasibility and utility of a rehabilitation inpatient group therapy program, which can serve as a useful model for other limb loss sites across Canada.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
130 Participants Needed
Virtual Reality for Pre-procedure Anxiety Before ECT
Toronto, Ontario
This trial uses VR to help patients scheduled for ECT by showing them a virtual experience of the procedure. This aims to reduce their anxiety and improve their understanding of ECT. By making patients more familiar with the process, the study hopes to lower their fear and increase the success rate of the treatment. Virtual reality (VR) has been used successfully to treat anxiety disorders and improve patient understanding of medical procedures.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
64 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
XPro1595 for Alzheimer's Disease
Toronto, Ontario
The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Substance Abuse, Others
Must Not Be Taking:Cannabis
201 Participants Needed
Patient Empowerment Program for Prostate Cancer
Toronto, Ontario
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Recent Myocardial Infarction, Stroke, Others
500 Participants Needed
School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being.
The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning.
Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (\~Oct-Dec) or the winter (\~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 18
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Others
3204 Participants Needed
Nocebo Education for ADHD Awareness
Toronto, Ontario
This project has two aims. First, the research team will confirm whether providing a mental health awareness workshop poses unintended harms by raising the rate of self-diagnosis (as opposed to a neutral workshop) and causing worsening symptoms in previously healthy young adults over a period of one week. The study will focus on determining this in the context of ADHD, as it includes broad symptoms that overlap with normal experience, is commonly overdiagnosed, and is included in many awareness campaigns for neurodiversity and mental health.
Second, the study will test whether nocebo effect education, or in other words, learning about the nocebo effects, during mental health awareness sessions "inoculates" against them. Simply learning about the role negative expectations play in creating side effects has been shown to reduce nocebo side effects of medications; perhaps, the same applies to mental health.
Researchers will compare the outcome of the ADHD workshop with that of the same workshop but with nocebo information included; both experimental conditions will also be compared to an active control condition. Participants are hypothesised to report the following pattern of symptoms:
ADHD information \> ADHD + nocebo education \> Control
During the study participants will:
1. Randomize the participants to one of the three workshop conditions to watch
2. Report self-diagnosis score immediately after the workshop and 1 week later.
3. Report symptoms 1 week later.
No Placebo Group
Trial Details
Trial Status:Completed
Age:18 - 25
Key Eligibility Criteria
Disqualifiers:Not Listed
215 Participants Needed
Exercise for Multiple Sclerosis
Toronto, Ontario
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population.
Participants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity.
The primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention.
Approximately 40 participants will be enrolled from four sites in Canada and the United States.
Primary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:11 - 25
Key Eligibility Criteria
Disqualifiers:Non-specific White Matter, Motor Disability, Cardiac Risk, Others
40 Participants Needed
Digital Dialectical Behavioural Therapy for High Risk
Toronto, Ontario
This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:16 - 29
Key Eligibility Criteria
Disqualifiers:Psychotic Disorder, Intellectual Disability, Others
60 Participants Needed
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.
The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.
The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 43
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychosis, Schizophrenia, Others
100 Participants Needed
MRI and MRS Brain Scans for Brain Mapping in Healthy Subjects
Bethesda, Maryland
Background:
- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.
Objectives:
- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.
Eligibility:
- Healthy individuals between 18 and 65 years of age.
Design:
* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center.
* Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing.
* During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Axis 1 Diagnosis, HIV, Neurological Illness, Others
300 Participants Needed
Lemborexant for Insomnia and Depression
Toronto, Ontario
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:
* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?
* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?
Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.
Participants will:
* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)
* Complete clinical assessments and in-person study visits
* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)
* Use a wearable device which will be used to collect and monitor physiological data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Abuse, Bipolar, Others
Must Not Be Taking:Sleep Aids, Antidepressants
30 Participants Needed
Restricted Social Media for Adolescent Mental Health
Washington, District of Columbia
The mental health of adolescents in the United States has seen a steep decline since 2011, roughly coinciding with the increasing popularity of social media and smartphones. But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? In this study, the investigators will conduct the first field experiment in 11-14-year-olds to examine whether, how, and for whom social media harms mental health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 14
Key Eligibility Criteria
Disqualifiers:Severe Developmental Problems, Severe Mental Illness, Suicidal Ideation
500 Participants Needed
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Frequently Asked Questions
How much do Mental Health clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Mental Health clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Mental Health trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Mental Health is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Mental Health medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Mental Health clinical trials?
Most recently, we added Social Media Intervention for Opioid Abuse, Engagement Navigator Service for Depression and Weyera Intervention for Mental Health Issues to the Power online platform.
What do the "Power Preferred" and "SuperSite" badges mean?
We recognize research clinics with these awards when they are especially responsive to patients who apply through the Power online platform. SuperSite clinics are research sites recognized for a high standard of rapid and thorough follow-up with patient applicants. Meanwhile, Power Preferred clinics are the top 20 across the entire Power platform, recognized for their absolute top patient experience.
Which clinics have received Power Preferred and SuperSite awards recruiting for Mental Health trials?
The Mental Health clinics currently recognized as SuperSites are: AMR Baber Research in Naperville, Illinois Ocean Medical Research in Toms River, New Jersey
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