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55 Mental Health Intervention Trials Near You
Power is an online platform that helps thousands of Mental Health Intervention patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBRIGHT Coaching Program for Developmental Disabilities
Montréal, Quebec
Children with, or at elevated risk for, brain-based developmental disabilities can experience lifelong consequences and challenges throughout their development. In particular, preschool years (3-6 years of age) can be stressful as families wait to get services and care for their child. Nationally and internationally, service delivery models during this critical period are not standardized, and differ within and across provinces and across patient conditions, leading to long wait times, service gaps and duplications.
This study has two main hypotheses:
1. A standardized approach to "coaching" (i.e. coach + online education tools + peer support network) is feasible in the real-life context, and acceptable to caregivers and can be delivered across multiple sites in urban/suburban/rural settings.
2. A standardized approach to "coaching" enhances parental health (parents' empowerment and sense of competence, quality of life, and minimizes parenting stress), family health care experience (care coordination experience and process of care) at similar health care cost (economic analysis), when compared to usual and locally available care.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 54
Key Eligibility Criteria
Disqualifiers:Not Listed
306 Participants Needed
Avatar Therapy for Cannabis Use Disorder
Montréal, Quebec
This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
32 Participants Needed
Occupational Intervention for ADHD
Montréal, Quebec
An adaptation of the Minds@Work intervention to improve quality of life at work for adults living with attention deficit disorder with/without hyperactivity (ADHD), following a group format.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Receiving Psychosocial Services
60 Participants Needed
COMPASS+ for Perinatal Mental Health
Providence, Rhode Island
The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings. The goal of this study is to adapt the CCM to the perinatal care context, including community co-designed adaptations to enhance health equity (COMPASS+). The main objectives of the study are to:
1. Evaluate the effect of COMPASS+ on depression symptom outcomes. Specifically we will evaluate population-level depression symptom trajectories and the prevalence of suicidal ideation among. We will also measure rates of depression response and remission for those who have elevated screen scores (i.e., PHQ9 ≥ 10)
2. Adapt, optimize, and evaluate COMPASS+ implementation strategies to the unique context of perinatal care and evaluate implementation outcomes. The RE-AIM framework will be used to evaluate implementation outcomes (acceptability, appropriateness, feasibility, and fidelity). We hypothesize that variability in effectiveness outcomes will be attributable to variability in fidelity to the implementation strategies or in implementation outcomes.
3. Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Age < 18
14820 Participants Needed
The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Severe Illness, Others
150 Participants Needed
Behavioral Intervention for Alcohol Use Disorder
North Little Rock, Arkansas
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Others
140 Participants Needed
Cognitive Processing Therapy for PTSD
Little Rock, Arkansas
Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release.
The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook
This study will:
* test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared to trauma-focused self-help,
* evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and
* measure the cost of the therapies and support strategies to help plan for future expansion.
Incarcerated participants (N = 640; 50% female) will be enrolled from \~10 prisons in \~5 states, ensuring variability in population and setting characteristics. They will:
* take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison)
* complete CPT group therapy or self-help therapy
* provide urine samples 3 months and 6 months after leaving prison
Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = \~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Early Release, Scheduling Conflicts, Others
640 Participants Needed
Stepped Care for Post-Traumatic Stress Disorder
Boston, Massachusetts
Posttraumatic stress disorder (PTSD) prevalence can be as high as 50% in low income and racially diverse primary care clinics, wherein only 13% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable, less burdensome to systems of care, and highly acceptable to diverse patients and care settings. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Current Therapy, Acute Suicide Risk, Others
Must Be Taking:Psychotropic
428 Participants Needed
Web-Based Therapy for PTSD
Boston, Massachusetts
Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services.
Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care.
The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Declines Participation
80 Participants Needed
Somatic Psychoeducational Intervention for Workplace Stress
Jacksonville, Florida
The goal of this clinical trial is to explore possible benefits and mechanisms through which the Somatic Psychoeducational Intervention can improve health and wellness. The main goals of the study are:
* To understand how the participants are doing with regard to their mindfulness, coping behaviors, emotional, physical, and work health, and autonomic reactivity (the degree participants physiologically respond).
* To examine regulation of the oxytocinergic system
* To investigate whether pre-intervention measures relate to the overall functioning
* To determine the 1-week and 1-month post-intervention effects of the Intervention(s)
* To identify individual characteristics that influence the effectiveness of the intervention at the 1-week and 1-month post-intervention assessments.
Participants will:
* complete the online pre-assessment measures regarding how they are doing emotionally and with respect to their work situation.
* listen to 15-minutes of calming music and provide pre and post-music salivary samples
* complete pre-intervention, post-intervention, 1-week post-intervention, and 1-month post-intervention assessments that involve completion of online measures and collection of saliva samples.
* participate in the intervention (which involves 4 hours; the 1-hour classes will be administered over four weeks).
Researchers will compare the Intervention Group A (in-person) to Intervention Group B (virtual) to see if the Intervention Group A experiences greater improvements in their health and wellness.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
30 Participants Needed
BEAM Program for Parental Mental Health
Winnipeg, Manitoba
Children are highly sensitive to adversity during their first five years of life, with exposure to chronic parental mental illness (MI) consistently linked to socio-emotional impairments and mental health problems in children. Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress, with parental MI reported at three times the pre-pandemic rates. This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children. In response, the investigators developed the Building Emotional Awareness and Mental Health (BEAM) program, an innovative mobile health (mHealth) solution for parents of young children. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. This trial involves an effectiveness-implementation hybrid design with co-primary aims of (1) determining BEAM's effectiveness in improving child mental health and developmental outcomes, and (2) evaluating the implementation of BEAM in the community through metrics such as feasibility, acceptability, and uptake. The secondary aim of this trial is to measure BEAM's effectiveness in improving long-term biopsychosocial family outcomes using administrative data. A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming.
This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app, with access to an online social support forum and check ins with a peer coach. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4).
Beginning in 2025, the trial offers participants the option to invite one parenting partner to join them in the program. A parenting partner is defined as a co-parent (e.g., the child's mother, father, or step-parent) or another primary caregiver (e.g., a grandparent, cousin, uncle, or aunt). Each participant may invite one such individual, hereafter referred to as a "co-parent." Co-parents will have access to the BEAM intervention and all its features, with the exception of peer coaching. Co-parents will be eligible to complete the same outcome measures at the same timepoints as participants. Three differences that will separate co-parents from participants are: (1) co-parents will not be asked to complete the ASQ:2-SE or ASQ-3 secondary outcome measures; (2) co-parents will not have access to peer coaching, and (3) co-parents will not be required to be experiencing moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger. (Please see Eligibility \> Eligibility Criteria for the less restrictive inclusion and exclusion criteria for co-parents.) Co-parents will not be counted toward the trial sample size of n=400, and will not be included in primary analyses. Instead, co-parent data will be used in sub-studies to address exploratory research questions.
The BEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related child functioning concerns. The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program, in a next step of testing BEAM's readiness for nationwide scaling.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Outside Manitoba, Child Not 2-5, Others
400 Participants Needed
Mobile App for Family Mental Health
Miami, Florida
The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6+
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Homicidal Ideation, Child Abuse, Others
357 Participants Needed
eHealth Familias Unidas for Depression and Anxiety
Miami, Florida
The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 16
Key Eligibility Criteria
Disqualifiers:Moving Out Of South Florida
468 Participants Needed
Cognitive Training for Mild Cognitive Impairment
Dartmouth, Nova Scotia
The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Neurological Conditions, Alcohol Abuse, Others
40 Participants Needed
Executive Functioning Interventions for Autism
Aurora, Colorado
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 99
Key Eligibility Criteria
Disqualifiers:Autism, Others
672 Participants Needed
Online Sleep Course for Insomnia
Regina, Saskatchewan
This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the Sleep Course, within a routine online therapy clinic (the Online Therapy Unit). The Sleep Course will specifically be offered to clients with self-reported sleep difficulties (i.e., falling or staying asleep or waking early) and daytime distress and or impairment. This study aims to replicate the effectiveness and acceptability of the previously evaluated Sleep Course when delivered in Australia. The investigators will also assess uptake and completion rates within the clinic as well as demographic and clinical characteristics of individuals enrolled in the Sleep Course.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Disorder, Severe Substance Use, Others
56 Participants Needed
Internet-Based Mental Health Program for Cystic Fibrosis
Regina, Saskatchewan
The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for children and adolescents with cystic fibrosis (CF) and their healthy siblings. The main questions it aims to answer are:
* Does the program improve the mental health such as depression and anxiety symptoms?
* Does the program improve overall quality of life?
* Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals?
Participants will:
* Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program
* Complete the online mental health program
* Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program
Participants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Severe Cognitive Impairment, Major Comorbid Illness
120 Participants Needed
Self-Help Program for Emotional Distress Due to Infertility
Regina, Saskatchewan
Now affecting one in six couples in Canada, infertility is defined as a lack of conception after 12 or more months of regular, unprotected sexual intercourse. Infertility can result from a number of causes; however, women are responsible for accommodating rigid treatment regimens and carry a disproportionate share of the psychological burden associated with infertility. Thirty to forty percent of women presenting for the evaluation of infertility experiencing clinically significant depression or anxiety. Yet access to infertility-specific mental health resources is extremely limited in Canada; current psychological interventions are not specialized to this population and are largely ineffective at reducing distress. Therefore, there is an enormous need to increase the efficacy and accessibility of mental health resources for this population.
To address this need, the 7-week Coping with Infertility (CWI) program was developed in collaboration with women with lived experience with infertility. The CWI program aims to reduce distress related to infertility and was recently tested in a small pilot study, where it was found to be very effective in reducing depression and anxiety and improving quality of life among individuals struggling to get pregnant. The goal of this clinical study is to test the CWI program in adult women experiencing infertility. The main questions it aims to answer are if the CWI program is effective at improving mental health and well-being in women experiencing infertility, and if demographic or lifestyle factors moderate the effect of the treatment. For seven weeks, participants will receive the CWI program and complete online questionnaires and interviews to assess the program's effects on infertility-related distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will then complete these questionnaires biweekly for 16 weeks following the program. Researchers will compare the CWI program to a waitlist/treatment as usual control condition to see if the program reduces psychological distress above and beyond women's ordinary coping strategies. If the program is effective in improving psychological well-being in this clinical study, the researchers will make the program widely and freely available to women throughout Canada and the world.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Under 18
170 Participants Needed
Pharmacist Care for Mental Health
Edmonton, Alberta
This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Abuse, Bipolar, Others
94 Participants Needed
Prenatal Yoga App for Pregnancy
San Diego, California
The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:
1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?
2. How does mental and physical health change after using the Down Dog app for 12-weeks?
3. What cultural adaptations to the Down Dog app are needed?
The study lasts for 12 weeks and participants are asked to:
* do prenatal yoga with the app for at least 20 min/day, three days/week, from home
* wear a Garmin Vivosmart 5 watch daily
* complete four online surveys
* complete an optional virtual interview
This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 46
Sex:Female
Key Eligibility Criteria
Disqualifiers:High-risk Pregnancy, Severe Psychiatric Disorder, Others
50 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"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 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
"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
"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
Collaborative Life Skills Tool for ADHD
San Diego, California
The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:7+
Key Eligibility Criteria
Disqualifiers:Visual Impairment, Hearing Impairment, Language Delay, Psychosis, Others
216 Participants Needed
Collaborative Life Skills for ADHD
San Diego, California
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Early Phase 1
Age:7+
Key Eligibility Criteria
Disqualifiers:Visual, Hearing, Language, Psychosis, Others
350 Participants Needed
Church-Based Interventions for Reducing Mental Health Stigma
Santa Monica, California
This study is a cluster randomized controlled trial of a Latino church-based intervention in Los Angeles and Riverside Counties. This study aims to leverage the collective resources of Latino religious congregations and the National Alliance on Mental Illness to test the effectiveness of a multi-component intervention directed at reducing stigma, increasing mental health literacy, and improving access to mental health services.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-congregant
1713 Participants Needed
Family Check-Up Online for Child Mental Health
Eugene, Oregon
The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English/Spanish Reader, Other Study
1270 Participants Needed
Counseling Program for Black Women with HIV
Miami, Florida
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Psychosis, Others
Must Be Taking:Antiretroviral Therapy
250 Participants Needed
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Frequently Asked Questions
How much do Mental Health Intervention 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 Intervention 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 Intervention 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 Intervention 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 Intervention 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 Intervention clinical trials?
Most recently, we added SBIRT for Alcohol and Substance Use Disorders, Cognitive Processing Therapy for PTSD and Stepped Care for Post-Traumatic Stress Disorder to the Power online platform.
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