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121 Psychological Distress Trials Near You
Power is an online platform that helps thousands of Psychological Distress 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 PowerPositive Audio Suggestions for Critical Illness-Related Stress
Rochester, Minnesota
The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Dementia, Psychotic Disorders, Hearing Impairment, Others
300 Participants Needed
Childbirth Support for Pregnancy in Incarceration
Little Rock, Arkansas
The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Under 18 Years
10 Participants Needed
Simulated Emergency Department Stress for Stress Management
Little Rock, Arkansas
Stress is important for health. As emergency departments (EDs) are often stressful places, a better understanding of the human stress response is important for understanding how and why patients respond as they do when they come to the ED. Since the investigators cannot take up space in the ED for research, the investigators will instead recruit 20 methamphetamine-using participants who are not currently in treatment and 10 healthy adult matched participants to a simulated ED room in the University of Arkansas for Medical Sciences (UAMS) Simulation Center. The investigators will have participants perform a stressor task involving public speaking and a simple arithmetic task. The investigators will see if this experiment can be made to be like being in an actual ED by varying what participants speak about in the task. By doing this, the investigators hope to find out several important things: 1) Is a stressor task feasible and acceptable to participants? 2) What does the stress response -- as measured by cortisol and alpha-amylase -- look like in these participants? 3) Does varying what participants talk about make the experiment seem more like an actual ED? 4) Do participants under stress show even mild symptoms of agitation as measured by clinical scales? If so, how often?
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 55
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Endocrine, Neurologic, Others
Must Not Be Taking:Daily Medication
30 Participants Needed
Narrative Medicine for Parents of Children With Urogenital Conditions
Boston, Massachusetts
The goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias).
The main questions it aims to answer are:
* Does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions?
* What are parents' perspectives on group-based writing interventions for future support programs?
Participants will:
* Complete a short anxiety questionnaire (the General Anxiety Disorder-7 scale) at the beginning of the study
* Receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition
* Complete 5 journal entries over several weeks, writing about their experiences and feelings
* Complete the same anxiety questionnaire again after finishing the journal entries
* Participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Disorder, Others
20 Participants Needed
AttentivU for Stress Management in Space Missions
Cambridge, Massachusetts
Crews of future long-duration exploration missions will have to cope with a wide range of stressors that present significant challenges for maintaining optimal performance. Crews will have to operate under conditions of high workload, reduced sleep and circadian dysregulation, limited sensory stimulation, confinement and extended separation from family and friends, and communication delays isolating them from real-time interaction with ground support, which may be particularly critical in the event of emergencies. These factors present significant risks to optimal cognitive/behavioral functioning and performance, across individuals and teams, and such challenges will only increase in criticality as human exploration moves beyond Earth's orbit to targets such as the Moon and Mars. To help mitigate these risks, Massachusetts General Hospital, along with collaborators at the Massachusetts Institute of Technology, will investigate a novel, personalized and scalable, closed-loop platform technology for on-board behavioral health management-one which adapts the local working environment to optimize performance based on biosensor feedback.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric Disorders, Others
80 Participants Needed
Resiliency & Burnout Interventions for Behavioral Health Staff
Boston, Massachusetts
The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are:
* Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors?
* Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents?
* What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC?
Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews.
Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Temp Staff, Per Diem Workers, Others
900 Participants Needed
JoyPop App for Mental Health in Students
Thunder Bay, Ontario
Students within post-secondary education settings are experiencing increasing stress, distress, and mental health difficulties. Many post-secondary education settings have identified student mental health and wellbeing as a priority and yet are struggling to adequately meet the needs of students. This has led to exploring whether technology can be used to help promote mental health and wellbeing among students. The JoyPop app is one mobile mental health app with a growing evidence base. It was developed to support improved emotion regulation - a key challenge among students struggling with distress and mental health difficulties. Using a randomized controlled trial (RCT) design, the primary objective of this research is to determine the effectiveness of the JoyPop app in improving emotion regulation among post-secondary students when compared to no intervention. The secondary objectives are to: (1) Assess change in mental health, wellbeing, and resilience between students in each condition to better understand the app's broader impact; (2) Conduct an economic analysis to determine whether receiving the app reduces other health service use and associated costs; (4) Assess students' perspective on the quality of the JoyPop app.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 25
Key Eligibility Criteria
Disqualifiers:Non-student, Under 18, Over 25, Others
120 Participants Needed
Cranberry Juice for Cognitive Symptoms
Gainesville, Florida
This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological stress, and stress response in healthy men and women between the ages of 30 and 55 who engage in multitasking. The trial will utilize a randomized, double-blinded, placebo-controlled design. It is worth noting that studies have shown that over half of middle-aged Americans experience stress, which can lead to cognitive decline and depression. Previous clinical trials have indicated that consuming polyphenol-rich foods can have positive effects on cognitive function in humans. However, no study to date has examined the long-term effects of cranberry juice consumption on cognitive performance, mental stress, and stress response specifically in individuals engaged in multitasking. Based on this gap in knowledge, the investigators hypothesize the following: (1) chronic consumption of cranberry juice will improve cognitive and motor accuracy, as well as mental and psychological stress responses in young adults subjected to intense multitasking. (2) cranberry juice consumption will alleviate the negative consequences of frequent intense multitasking, such as fatigue, mood fluctuations, cognitive impairment, and memory issues. Additionally, it is expected to have a positive impact on stress biomarkers and neurotransmitter levels. By conducting this clinical trial, the investigators aim to shed light on the potential benefits of cranberry juice consumption in improving cognitive performance, mitigating mental stress, and positively influencing stress responses in individuals who engage in intense multitasking.
Trial Details
Trial Status:Recruiting
Age:30 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
126 Participants Needed
RISE Program for Physician Burnout
Orlando, Florida
The purpose of this study is to determine whether the RISE for Physicians program has a significant impact on physicians' burnout, resilience, insight, self-compassion, empowerment, and professional and personal mental health and well-being.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Resident Physician, Advanced Practice Provider, Executive Leader
36 Participants Needed
Weaving Healthy Families Program for Substance Use and Domestic Violence
New Orleans, Louisiana
Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among Native Americans (NA), making the long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse and violence in NA families by testing an efficacious, sustainable, culturally-relevant and family-centered intervention for cross-national dissemination. The central hypothesis is that the sustainable and community-based Weaving Healthy Families program, will reduce and postpone AOD use among NA adults and youth, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. The expected outcomes of the proposed research are an efficacious, culturally relevant, and sustainable community based program to promote health and wellness that will address the factors that drive health disparities and promote individual, family, and community resilience.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:5+
Key Eligibility Criteria
Disqualifiers:Current Protective Order, IPV Record
1000 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
Stress Inoculation Training for Stress
Houston, Texas
The purpose of this study is to demonstrate the feasibility of augmenting existing/traditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Psychotic Disorder, Bipolar, Substance Abuse, Others
120 Participants Needed
This trial tests a smartphone app designed to help unpaid caregivers of Alzheimer's patients manage their emotions better. The app teaches techniques to view stressful situations more objectively and imagine better outcomes, aiming to reduce stress and improve overall well-being.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Psychotherapy, Visual Impairment, Cognitive Impairment, Others
270 Participants Needed
Group Therapy for PTSD After Combat
Temple, Texas
This trial aims to help combat veterans with PTSD from morally injurious events by using group therapy. Veterans will talk about their experiences with others who understand, helping them make sense of their feelings and improve their mental health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Suicidal Ideation, Cognitive Impairment
12 Participants Needed
Security Force Assistance Brigades (SFABs) are specialized United States Army units formed to train, advise, assist, enable and accompany operations with allied and partner nations. Security Force Assistance Brigades are composed of roughly 800 senior military personnel, primarily commissioned and non-commissioned officers selected from regular Army units across a wide range of military specialties. Because of the high operational tempo (OPTEMPO) of these units, individual resiliency is of utmost importance in maintaining readiness to successfully execute critical, high-stress missions. Acceptance and Commitment Training (ACT) is an evidence-based intervention with strong potential to enhance resiliency by bolstering psychological flexibility along with other factors which have been demonstrated to optimize individual and group performance. This project will compare an Acceptance and Commitment Training-based resiliency-enhancement training program as compared to training as usual in 600 3rd Security Force Assistance Brigades soldiers stationed at Fort Hood in Killeen, Texas. Assessment measures related to resilience will be administered before and after training as well as before and after deployment. Assessments will be conducted at baseline, and every 4 months thereafter for a total of 16-months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
600 Participants Needed
Storytelling Through Music for Burnout
Austin, Texas
Homelessness is a complex social issue and requires a dedicated workforce of helping professionals, including nurses and social workers. Secondary traumatic stress is common in this workforce and contributes to poor professional quality of life, burnout, and job turnover. These factors undermine the health and well-being of homeless service providers and threaten the stability of this critical workforce. The purpose of this study is to evaluate "Storytelling Through Music," an innovative 6-week, multi-dimensional intervention, to improve well-being among homeless service providers.
No Placebo Group
Trial Details
Trial Status:Completed
Key Eligibility Criteria
Disqualifiers:Not Listed
14 Participants Needed
TF-CBT for Adolescent Post-Traumatic Stress Disorder
San Antonio, Texas
Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Psychosis, Bipolar, Autism, Others
Must Not Be Taking:Psychiatric Medications
180 Participants Needed
Peer Support Intervention for COVID-19 Related Mental Health Issues
Albuquerque, New Mexico
This study tests the effectiveness of a community-based peer advocacy, mutual learning, and social support intervention (Refugee and Immigrant Well-being Project) to reduce several negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx and Black populations: psychological distress, financial problems, and daily stressors. In partnership with five community-based organizations that focus on mental health, legal, education, and youth issues with Latinx immigrants and African refugees, we will also be able to examine the effects of people's involvement with community-based organizations and local and state policy changes on their mental health, economic stability, stressors, and social support. This is important not only for Latinx and Black populations and the large number of immigrants and refugees in the United States and worldwide, but also because the intervention model and what we learn from this study have the potential to alleviate mental health disparities experienced by other marginalized populations who face unequal access to social and material resources, disproportionate exposure to trauma and stress, and worse consequences of the COVID-19 pandemic.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Cognitive Problems, Severe Mental Illness
1212 Participants Needed
Chronic health conditions (CHC) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the United States. Long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. With the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, ACT may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. Previous web-based ACT interventions for CHCs have focused on building ACT skills for a narrow subset of CHCs (e.g., breast cancer, diabetes, tinnitus). While there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in CHCs, shared challenges in illness management and coping, and clear evidence that ACT works effectively across CHCs to improve quality of life. Thus, our goal of this research project is to evaluate a new 6 session, online, self-guided ACT program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. The specific aims are:
1. To evaluate the feasibility of an initial prototype of ACT program for adults with CHC's as indicated by recruitment, retention, and adherence rates.
2. To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion.
3. To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback.
4. To test the efficacy of the program on improving quality of life among adults with CHC's.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
101 Participants Needed
Psychological Stress Task for Cardiometabolic Conditions
Browning, Montana
Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension
400 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
"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
"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
"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
"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
Primal Reflex Release Technique for Stress
Moscow, Idaho
Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Not Listed
30 Participants Needed
Race-Based Stress Trauma and Empowerment Program for Racism-Related Stress
San Diego, California
The existence of racially/ethnically based health disparities is well established, both within the civilian community and among Service Members and Veterans. Experiences of discrimination are acute and chronic stressors that substantially contribute to greater emotional distress, poorer health behavior, lower healthcare utilization and increased allostatic load, all of which undermine well-being, functioning and Whole Health. An innovative clinical program, the Race-Based Stress/Trauma and Empowerment (RBSTE) group, was developed to help Veterans of Color to build coping resources and empowerment. Although qualitative data suggest the promise of this intervention, systematic evaluation is lacking. The proposed feasibility project will lay the groundwork for a future randomized controlled trial to evaluate RBSTE as compared to a control group in terms of Whole Health, functioning and mental/physical wellness. The project thus begins a program of research to address the health implications of systemic racism.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
32 Participants Needed
RISE Program for Pregnancy-Related Depression and Anxiety
Los Angeles, California
Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychosis, Perinatal Loss, Others
150 Participants Needed
Botox for Stress
Beverly Hills, California
The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period.
Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis.
Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment.
The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve:
* vital signs and Body Mass Index (BMI) measurements
* basic/interval history and physical
* 2 Perceived Stress Scale (PSS) questionnaires
* injection of 64 units of either BOTOX® or sterile salt solution
* stay for 60-minutes after treatment for monitoring and to complete study tasks
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychiatric Diagnosis, Metabolic Disorders, Others
Must Not Be Taking:Neuromuscular Medications
20 Participants Needed
Stress Management for Food Insecurity
Los Angeles, California
This study will use a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 50% men). These participants will then, in counterbalanced order, be exposed to a gold-standard laboratory stressor and a control condition, one month apart. Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Mood Disorders, Schizophrenia, PTSD, Others
Must Not Be Taking:Steroids, Hormonal Contraceptives
400 Participants Needed
Nerve Fiber Stimulation for Alcoholism
Seattle, Washington
CT fibers are found in the skin of most mammals and project to the insular cortex. Stimulation of CT fibers by light touch causes a release of oxytocin and is associated with feelings of comfort and wellbeing. Peripheral TRPV-1 channels are important in pain transmission and modulation of the stress response likely through the central release of oxytocin and are stimulated by heat. In Phase 1 investigators will test stimulation of TRPV1 channels and CT fibers in human subjects to correlate the lab findings with subjective human responses and test whether stimulation of CT fibers and TRPV-1 channels reduce anxiety and stress in subjects who suffer from AUD. Aim 1 and 2. We will define the optimal parameters for CT fiber stimulation for force, temperature, and body location. We will perform similar testing for peripheral thermal stimulation (TRPV-1) using our commercially available heating pods. Parameters tested will include the optimal body location, number of heating pods (2-4) and temperature of pods. In Aim 3 investigators will simultaneously apply both CT fiber and thermal stimulation in a proof of concept study. The experimental group will receive active CT fiber and thermal stimulation and the control group non-physiologic placebo stimulation. Subjects with a history of AUD will be randomized into control versus experimental groups and undergo stress using a validated mental calculation stressors. Stress, cravings, and anxiety will be measured using standardized assessments, and investigators will measure salivary oxytocin and cortisol levels, potentially biomarkers.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
36 Participants Needed
Psilocybin for Post-Traumatic Stress Disorder and Alcoholism
Seattle, Washington
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety, efficacy, and durability of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 18-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe and effective treatment for participants.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Schizophrenia, Bipolar, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Stimulants, Psychedelics
40 Participants Needed
Web Application for Sibling Stress Support
Springfield, Oregon
Most of the over 32.7 million people in the U.S. who have special health, developmental, and mental health concerns have typically developing (TD) brothers and sisters who share high levels of involvement in their sibling's lives. Disability and health agencies lack effective tools to support the information and support needs of TD siblings and their families, in particular for ethnic minority and rural families. The aims of this proposal are to complete development and evaluation of the dual language SIBTime app, designed to build parents' and children's knowledge, skills, and engaging family routines to nurture TD siblings' (ages 3-6) social-emotional health and well-being.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
160 Participants Needed
Mindfulness-Based Interventions + CCT for Traumatic Stress
Palo Alto, California
In the last four years alone, residents of Puerto Rico have experienced a slew of natural disasters including Hurricane Maria in 2017, earthquakes in 2019 and 2020, the continued COVID-19 pandemic from 2020-2022, and most recently Hurricane Fiona. This series of distressing events can lead to an increased need for mental health resources and trauma treatment. Furthermore, the unique single-district structure of the Puerto Rican education system allows for the efficient dissemination of potential interventions and treatment to all students.
The purpose of this study is to examine two treatment conditions for educators and school-aged children in Puerto Rico experiencing burnout, fatigue, and high stress: delivery of a mindfulness-based educator curriculum and, for children who report Post Traumatic Stress Disorder (PTSD) symptomatology, delivery of the mindfulness curriculum with the additional intervention of Cue-Centered Therapy (CCT). The study has two aims: 1) To assess the efficacy of the mindfulness curriculum and of CCT in a population of students, counselors, and teachers, characterized by high stress over the last few years of natural disasters and pandemic challenges and 2) To identify genetic contributions to resilience by analyzing gene expression in students before and after the intervention.
The overarching goals of the investigators' research collaboration are to improve educators' psychological well-being and children's socioemotional development when faced with high stress and adversity and to improve mental health clinicians' competence and confidence in treating children exposed to trauma by training them in CCT. The investigators' research will identify critical biopsychosocial components responsible for the cognitive, behavioral, and emotional improvement and effective implementation strategies in a large but geographically dispersed school district. The knowledge base that will result from this study will inform the implementation of trauma-informed care in school settings and with populations experiencing stress and adversity, and contribute to the investigators' understanding of the underlying biology of these interventions to provide a rationale for further development and dissemination.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 17
Key Eligibility Criteria
Disqualifiers:Current Trauma Therapy, Low IQ, Substance Dependence, Autism, Schizophrenia, Others
80800 Participants Needed
Diabetes Prevention Program for Obesity
San Francisco, California
This is an research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Myocardial Infarction, Others
15 Participants Needed
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Frequently Asked Questions
How much do Psychological Distress 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 Psychological Distress 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 Psychological Distress 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 Psychological Distress 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 Psychological Distress 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 Psychological Distress clinical trials?
Most recently, we added Stress Inoculation Training for Stress, Mind-Body Conditioning for Student Burnout and Psilocybin-Assisted Therapy for Intergenerational Trauma to the Power online platform.
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