Anxiety & Depression Association of America

Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.

Type: Interventional

Start Date: Aug 2023

open study

Thought-Action-Fusion (TAF) is a cognitive bias that posits (1) having unwanted thoughts is morally equivalent to acting upon the thoughts (TAF-Moral; e.g., "Thinking about harming a child is as immoral as actually harming a child") and (2) having unwanted thoughts will increase the likelihood of the thoughts happening in real life (TAF-Likelihood; e.g., "My mother will get into a car accident, because I thought about it"). Given its central role in the development and maintenance of OCD, TAF has emerged as a potential treatment target for obsessive-compulsive disorder (OCD). Previous research has demonstrated that TAF is indeed a malleable construct. This study aims to examine the effects of a multi-session, personalized cognitive bias modification (CBM) for thought-action-fusion (TAF) on improving obsessive-compulsive (OC) symptoms in a college sample.

Type: Interventional

Start Date: Apr 2024

open study

Researchers aim to test a brief culturally-responsive young adult orientation program for community mental health services. They will conduct a 24-month randomized trial with 80 young adults from racial and ethnic minority groups in a community-based mental health clinic.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical trial is to conduct a randomized controlled trial to enhance the capacity of pediatric primary care providers to assist their patients who struggle with anxiety. The study aims to refine and assess the feasibility of the Anxiety Action Plan (AxAP), a brief intervention to reduce pediatric anxiety, delivered by primary care providers (PCPs) in community pediatric primary care clinics. The goal of the AxAP is to enhance the capacity of PCPs to identify and intervene with anxious youth, which will enhance access to care in general and especially in locations with few mental health specialists. PCPs participating in this study will attend a training, administer the intervention to enrolled youth assigned to the MAPP condition, participate in coaching sessions, and fill out study questionnaires. Families participating in this study will complete evaluations with the study team, receive the intervention from their PCP (if assigned to the MAPP condition), and fill out study questionnaires. Researchers will compare the MAPP intervention to Enhanced Usual Care (EUC; consisting of videos, handouts, and other resources for anxiety reduction) to see the differences, if any, in child outcomes.

Type: Interventional

Start Date: Nov 2023

open study

The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question[s] it aims to answer are: - the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain - the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.

Type: Interventional

Start Date: Apr 2024

open study

A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).

Type: Interventional

Start Date: Dec 2023

open study

Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.

Type: Interventional

Start Date: Sep 2023

open study

Deficits in motivation and pleasure are common in depression, and thought to be caused by alterations in the ways in which the brain anticipates, evaluates, and adaptively uses reward-related information. However, reward processing is a complex, multi-circuit phenomenon, and the precise neural mechanisms that contribute to the absence or reduction of pleasure and motivation are not well understood. Variation in the clinical presentation of depression has long been a rule rather than an exception, including individual variation in symptoms, severity, and treatment response. This heterogeneity complicates understanding of depression and thwarts progress toward disease classification and treatment planning. Discovery of depression-specific biomarkers that account for neurobiological variation that presumably underlies distinct clinical manifestations is critical to this larger effort.

Type: Observational

Start Date: Jun 2021

open study

Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs. By studying methods to non-invasively target neural circuitry involved in reward responsivity, information generated by this project will improve understanding of the circuit alterations that underlie motivation and pleasure deficits in depression, and could also lead to the development of biologically-based markers of neurostimulation-based treatment response.

Type: Interventional

Start Date: Oct 2021

open study

The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD (Post Traumatic Stress Disorder) as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

Type: Interventional

Start Date: Apr 2024

open study

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Type: Interventional

Start Date: May 2024

open study

Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are: 1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD? 2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment? Participants will be asked to: - Undergo ERG recordings before and after a single dose of sertraline. - Provide relevant clinical information related to PTSD symptoms and treatment history. Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording.

Type: Interventional

Start Date: Feb 2024

open study

This study aims to test whether aerobic exercise performed after fear extinction learning improves cognitive, physiological, and neural indices of extinction recall in a sample of trauma-exposed men and women with and without posttraumatic stress disorder (PTSD). Participants will complete a clinical intake visit (Day 0), followed by a three-day fear conditioning (day 1), fear extinction + activity (day 2), and fear extinction recall (day 3) protocol.

Type: Interventional

Start Date: Jan 2024

open study

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

Type: Interventional

Start Date: Nov 2021

open study

Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.

Type: Interventional

Start Date: Nov 2018

open study

Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD. Objective: To understand how nicotine affects symptoms of depression and related brain function. Eligibility: People aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products. Design: Participants will have 2 or 3 study visits over 1 year. Participants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs. Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan. For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours. Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan. They will have a blood test after each scan.

Type: Interventional

Start Date: Feb 2023

open study

This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.

Type: Observational

Start Date: May 2026

open study

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of ~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.

Type: Interventional

Start Date: May 2026

open study

The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them. The main questions this study aims to answer are: - Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)? - Is the program usable and acceptable/appropriate/feasible to implement in this setting? - Do parents show improvements in mental health and coping-related outcomes after participating in the program? - What are the experiences and perspectives of parents and therapists regarding the program? Parents as participants will: - Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics. - Complete online questionnaires before starting and after completing the program. - Take part in one online interview about their experiences and perspectives on the program. Occupational therapists as participants will: - Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist. - Complete brief online questionnaires before starting and after delivering the program. - Take part in one online interview about their experiences and perspectives on the program.

Type: Interventional

Start Date: Mar 2026

open study

The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.

Type: Observational

Start Date: Jan 2026

open study

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Type: Interventional

Start Date: Nov 2025

open study

This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.

Type: Interventional

Start Date: Jul 2025

open study

This research study aims to understand how people with depression respond to the medication pramipexole and to determine whether clinical response differs depending on the function of specific circuits in the brain. The investigators hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition. Eligible participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. The ultimate goal is to offer people experiencing depression a medication that is alternative to ones that may not have worked in the past and to apply the knowledge the investigators gain from investigating the brain circuits involved in depression to help personalize treatment. The investigators invite anyone who has recently experienced symptoms of depression to participate. A prior diagnosis of depression is not required.

Type: Interventional

Start Date: Jan 2026

open study

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Type: Interventional

Start Date: Jul 2025

open study

A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).

Type: Interventional

Start Date: Apr 2026

open study