Anxiety & Depression Association of America

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

Type: Interventional

Start Date: Jan 2025

open study

This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial. The main questions this trial aims to answer are: - Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents? - Is SAINT® a feasible option as a first-line treatment for adolescent depression? Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment. Adolescent participants will: - Remain antidepressant-free throughout the study period of 6-7 weeks. - Receive an MRI of their head for precision targeting - Receive 5 days of aiTBS (SAINT®)

Type: Interventional

Start Date: Jan 2025

open study

This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory. Using the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio

Type: Interventional

Start Date: Apr 2023

open study

This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.

Type: Interventional

Start Date: Mar 2020

open study

Multiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).

Type: Observational

Start Date: Oct 2023

open study

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.

Type: Interventional

Start Date: Mar 2020

open study

The primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Type: Interventional

Start Date: Jul 2024

open study

Using a randomized controlled trial design, the investigators will examine the effects of music engagement through choir training on the hearing, communication, and psychosocial well-being of older adults, particularly those at heightened risk of developing dementia.

Type: Interventional

Start Date: Oct 2024

open study

Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.

Type: Interventional

Start Date: Nov 2023

open study

This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.

Type: Interventional

Start Date: Jun 2023

open study

The purpose of this study is to investigate the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in inducing anti-depressant responses in individuals with treatment-resistant depression of bipolar II disorder. This is a double-blind, randomized, sham-controlled trial that targets a single location on the left dorsolateral prefrontal cortex (LDLPFC) using the MagPro rTMS system.

Type: Interventional

Start Date: Dec 2022

open study

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. The screening and ability to interact online with a clinician anonymously are hypothesized to increase willingness to come for counseling in person. Suicide risk factors are expected to be lower once the distressed medical trainee or faculty member receives treatment.

Type: Interventional

Start Date: Jan 2014

open study

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

Type: Interventional

Start Date: Aug 2023

open study

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.

Type: Interventional

Start Date: Jul 2019

open study

- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users - Assess creatine's effect on methamphetamine use - Assess the safety of creatine in male methamphetamine users with depression

Type: Interventional

Start Date: Nov 2015

open study

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Type: Interventional

Start Date: Apr 2026

open study

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

Type: Interventional

Start Date: May 2026

open study

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Type: Interventional

Start Date: Apr 2026

open study

The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.

Type: Interventional

Start Date: May 2026

open study

The purpose of the study is to evaluate a trauma informed digital multicomponent intervention design to improve health and safety outcomes for women with lifetime exposures to violence and co-occurring PTSD and/or depression symptoms

Type: Interventional

Start Date: Nov 2025

open study

The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. The investigators hypothesize that transcranial photobiomodulation (tPBM) can be used in conjunction with attention bias assessment and modification to reduce anxiety symptoms in individuals with sub-clinical anxiety.

Type: Interventional

Start Date: Sep 2025

open study

The study will compare the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder or dysthymia.

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

Type: Interventional

Start Date: Feb 2026

open study

There has been much interest in the potential role of social media (SM) use in driving a current mental health crisis among teens, with a dire need for evidence that goes beyond self-report. One important avenue is to understand the role of the brain in driving the effects of SM use on emotional health and vice versa. However, there is almost no research addressing these questions, largely due to a lack of tasks that can probe the neural correlates of modern SM use. The goal of this clinical trial is to develop and validate a new developmentally-appropriate and ecologically-valid functional magnetic resonance imaging (fMRI) and eyetracking task, the TeenBrainOnline (TBO) Task, that is more realistic and similar to modern SM platforms. Participants will be 50 teens (ages 13-17) with depressive symptoms who will complete the final version of TBO task during fMRI with eye-tracking, an older Chatroom Interact (CHAT-I) Task, daily surveys of SM use, and measures of depressive symptoms. Our goal is to show that the task works by: - Demonstrating that it activates expected regions of the brain and visual attention biases toward feedback cues. - Showing that brain and eyetracking (visual attention) activity on the task explain variability in depressive symptoms at baseline and three months later, and work better than similar indices from an older task. - Showing that brain and eyetracking (visual attention) activity on the task are associated with real-world measures of social media use collected during daily surveys. Specifically, The investigators expect that teens whose brain and eyetracking activity suggests they are more sensitive to feedback on SM will report a social evaluation orientation toward social media use in daily life, such as engaging a lot in social comparison, worrying about missing out, and caring about getting a lot of likes and comments. Participants will be asked to: - complete a 10-15 minute screening call to determine eligibility for the study - complete one 90 minute virtual study visit to complete questionnaires and prepare for the MRI visit (visit 1) - submit 24 photos to our study specific social media site - complete an (in person) MRI scan visit (~4 hours), which consists of 2 tasks where they will interact with peers (visit 2) - complete ~5 minute smartphone surveys 3 times a day for 16 days, asking about their daily experiences online and emotional reactions. - complete 2 online questionnaires asynchronously 3 months after their scan date

Type: Interventional

Start Date: Mar 2025

open study

In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all affiliated with MUSC and within 2-hours driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable feasibility, safety, and efficacy lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option, both in our state and across the US.

Type: Interventional

Start Date: May 2025

open study