Anxiety & Depression Association of America

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Type: Interventional

Start Date: Nov 2024

open study

The overall objective of this in-lab randomized controlled trial is to test the efficacy of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, affective, and cardiac autonomic nervous system responses in children with overweight and obesity who are at risk for type 2 diabetes. The use of continuous glucose monitoring will provide insight into the daily and cumulative metabolic effects of each condition that have thus far not been studied. In-lab studies demonstrating sustained efficacy of this approach in ameliorating negative effects of sedentary behaviors in children are necessary for the optimization of field-based interventions. Given the lack of success of interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in children and its related healthcare costs, this study addresses a critical public health need by testing of novel intervention strategies to reduce obesity-related diseases in children with overweight and obesity.

Type: Interventional

Start Date: Mar 2022

open study

The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are: - Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM - Aim 1: establish that gamified ABM is at least as effective as traditional ABM. - Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy. - Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers. If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression.

Type: Interventional

Start Date: May 2024

open study

In response to large numbers of senior center clients who suffer untreated depression and the dearth of geriatric mental health providers, the investigators have simplified Behavioral Activation to be delivered by lay volunteers ("Do More, Feel Better"; DMFB). The focus of Behavioral Activation is to guide clients to reengage in daily pleasant and rewarding activities, and reduce depressive symptoms. If the investigators can show that the lay delivery model has positive impact in comparison to MSW-delivered Behavioral Activation, the investigators will have identified an effective intervention that can be used by a large untapped workforce of older adult volunteers across the nation.

Type: Interventional

Start Date: Jan 2021

open study

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

Type: Interventional

Start Date: Jan 2025

open study

Growing up in a lower-income family robustly predicts worse mental health in adolescence and early adulthood. How does variability in family income "get under the skin" of the developing child and via what mechanisms does it increase risk for mental illness? Moreover, could supplements to family income at critical developmental periods help to prevent later youth mental illness? To address these questions, we leverage an innovative existing double blind randomized controlled trial of 3-years of substantial income supplements to parents. By experimentally studying the impacts of these income supplements on families and subsequent youth development, we can examine causal pathways from family income to risk for mental illness via family stress and neuroimmune mechanisms in ways never done before. Moreover, by measuring the longer-term impact of 3 years of income supplements to parents on their child's neuroimmune signaling and risk for mental illness, we can examine the policy implications for child development of unconditional cash transfers to parents and identify how and for whom these supplements help. We will test these basic and translational questions in a sample of 1,200 youth with lower-income parents randomly assigned to receive either a substantial monthly income supplement or a minimal monthly supplement for 3 years, starting when youth were between age 5 - 14 years old. We will follow up with youth and their parent 1 - 2 and 3 - 4 years after the intervention and examine whether income supplements predict better youth mental health during adolescence, as well as whether factors like child age and neighborhood quality modulate intervention effects. Additionally, we explore family stress mechanisms through which the intervention may impact child mental health. Finally, we will measure peripheral inflammation (inflammatory biomarkers and classical monocytes) and use MRI to assess threat, reward, and regulatory neural activity and connectivity among 500 of these youth. Our central hypothesis is that income supplements will decrease family and youth stress and improve parenting, which will improve neuroimmune signaling and decrease risk for psychopathology. Moreover, these effects will remain years after termination of the transfers and be strongest among families who received the intervention earlier in the child's life. This research will provide timely, relevant public health knowledge that will help policy makers understand the longer-term brain, immune, and mental health impacts of cash transfers to parents, while also advancing the science of the sociocontextual and neuroimmune pathways through which variability in family income impacts risk for psychopathology.

Type: Interventional

Start Date: Apr 2026

open study

Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.

Type: Interventional

Start Date: Jan 2026

open study

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Type: Interventional

Start Date: Aug 2025

open study

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Type: Interventional

Start Date: Mar 2025

open study

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This randomized controlled trial (RCT) is phase 2 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs). This 2-arm trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.

Type: Interventional

Start Date: Aug 2024

open study

The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.

Type: Interventional

Start Date: Jan 2025

open study

This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).

Type: Observational

Start Date: Jun 2021

open study

Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exercise, and (3) use of a wrist-worn activity monitor for physical activity (PA) feedback and activity goal setting. Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased exercise outcomes (short-term moderate-to-vigorous intensity physical activity and steps/day). The investigators' present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in cardiac rehabilitation (CR) patients and examine whether changes in this target yield successive changes in exercise adherence outcomes.

Type: Interventional

Start Date: May 2022

open study

The purpose of this research is to examine the effects of two different exercise training regimens for managing depression and improving other health indicators among persons with multiple sclerosis (MS). The project will enroll persons with MS and major depressive disorder (MDD) between 18 and 64 years of age. The investigators will enroll a total of 146 participants. This is a Phase-II trial that compares the efficacy of an exercise training program (POWER-MS) compared with a stretching program (FLEX-MS) for immediate and sustained reductions in the severity of depression among persons with MS who have MDD.

Type: Interventional

Start Date: Apr 2023

open study

This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.

Type: Interventional

Start Date: Apr 2026

open study

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend

Type: Interventional

Start Date: May 2026

open study

Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.

Type: Interventional

Start Date: Jan 2026

open study

Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.

Type: Interventional

Start Date: May 2026

open study

PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and observational results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD. This randomized trial will compare dextrose injection with an injection control of normal saline (NS)

Type: Interventional

Start Date: May 2026

open study

This study is evaluating On-Trac (Online Training After Cancer), an online educational intervention to teach adult cancer survivors strategies to address anxiety based on Cognitive-Behavioral Therapy (CBT) and Acceptance Commitment Therapy (ACT) The name of the study intervention is Online Training After Cancer (On-Trac)

Type: Interventional

Start Date: Mar 2026

open study

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Type: Interventional

Start Date: Dec 2025

open study

In this study, investigators are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp. The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. Investigators will check skin comfort, mood, and overall tolerability after each session.

Type: Interventional

Start Date: Dec 2025

open study

In the U.S., legal cannabis is frequently advertised as an effective treatment for mental health problems such as anxiety and depression-particularly online. States that have legalized cannabis have not implemented regulations to address this type of advertising. This project aims to investigate the influence of psychotherapeutic advertising claims (PAC) and mental health warning labels (WL) on online cannabis purchasing behaviors among light-to-moderate cannabis users with symptoms of depression and/or anxiety. The specific aims are to determine whether PAC increases cannabis purchasing intentions and whether a mental health WL can mitigate this effect. A realistic online cannabis shopping experience will be simulated using the digital Platform for Online Evaluation of Marijuana Marketing and Sales (POEMMS). The study will employ a between-subjects experimental design by randomizing 2,000 participants to one of four online stores that vary in PAC and WL content: (1) a control claims (CC)-only store, (2) a PAC store, (3) a WL store, and (4) a PAC + WL store. Participants will browse and select items as if making real purchases. Analyses will examine three primary outcomes to determine the influence of PAC and WL on purchasing behaviors: (1) total milligrams of THC purchased, (2) average potency (%THC) of products, and (3) overall number of products purchased. The long-term objective is to inform evidence-based cannabis policy and regulatory strategies by understanding the impact of cannabis marketing on vulnerable populations. This research is relevant to public health by addressing the potential risks associated with misleading cannabis marketing, which may lead to increased use and exacerbation of mental health symptoms among individuals with depression and anxiety. The project leverages a multidisciplinary team with expertise in addiction, mental health, epidemiology, and digital health technology. The findings have the potential to inform the development of targeted interventions and policies to reduce harms associated with cannabis advertising-ultimately contributing to better health outcomes and more effective regulation.

Type: Interventional

Start Date: Apr 2026

open study

This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.

Type: Interventional

Start Date: Jan 2026

open study