Anxiety & Depression Association of America

The proposed study is an open-label trial of Re-Timer® wearable morning bright light therapy for postpartum depression. The study is focused on evaluating the feasibility, acceptability, and implementation context of morning Bright Light Treatment (mBLT) for postpartum depression.

Type: Interventional

Start Date: Jul 2026

open study

The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth. The main questions this study aims to answer are: - Does using the chatbot improve postpartum pelvic floor health knowledge? - Does using the chatbot help reduce feelings of loneliness during the postpartum period? - Does using the chatbot impact pelvic floor symptoms? Researchers will compare standard postpartum care to standard care plus the chatbot. Participants will: Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot. If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period. Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress. The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.

Type: Interventional

Start Date: Jan 2026

open study

Researchers hope to see if the data smartphones collect continuously can be used to predict if patient's depression symptoms will return. They will do this by collecting data from patient's smartphones and comparing it to their depression symptoms. If this method is successful, researchers could develop a smartphone application to help healthcare providers better monitor patient's depression and intervene earlier if symptoms return.

Type: Interventional

Start Date: May 2026

open study

This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.

Type: Interventional

Start Date: Aug 2026

open study

NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Type: Interventional

Start Date: Jun 2025

open study

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Type: Interventional

Start Date: Oct 2024

open study

This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Type: Interventional

Start Date: Jul 2024

open study

In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

Type: Interventional

Start Date: Nov 2024

open study

This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.

Type: Interventional

Start Date: Dec 2025

open study

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Type: Interventional

Start Date: Jun 2022

open study

This study is intended to help develop new MRI imaging techniques for studying mood and anxiety disorders. Researchers believe that depression and anxiety disorders may cause structural and functional changes in the brain. This study will optimize the way MRI scans are collected to look at brain structure and examine how the brain behaves while subjects perform particular tasks. Healthy volunteers and individuals with major depressive disorder may be eligible for this study. Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing. : Individuals will be asked to participate in an MRI study on one of several scanners. The scanner used will measure blood flow in the brain, concentrations of certain chemicals in the brain, or magnetic properties of the brain. The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds. Participants may be asked to return for additional scans. The study also involves neuropsychological tests, which assess cognitive performance. Often, people with mood disorders have subtle changes in performance on these tests that allow researchers to pinpoint where brain abnormalities occur. Before the tests can be used in patients, they must be validated by using healthy subjects. These tests are presented either orally, in written form, or on a computer.

Type: Observational

Start Date: Dec 2006

open study

Aromatherapy's Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience Introduction: Surgery often results in increased levels of anxiety and postoperative pain. Postoperative pain relief is typically treated with opioids. However, evidence shows that treatment with opioids alone is often insufficient to provide adequate levels of pain relief and can contribute to the growing opioid crisis. Alternative pain management strategies that combine narcotic medication with complementary therapies can improve comfort as well as decrease preoperative anxiety. Aromatherapy is an evidence-based complementary therapy used to decrease preoperative anxiety and postoperative pain that has been underutilized in ambulatory surgical centers. This study aimed to evaluate the impact Aromatherapy has as an anxiety and pain management strategy. Subsequently, evidence also supports that improving the patient experience can lead to better surgical outcomes. Study Aim: This study will examine the effect that aromatherapy has on preoperative anxiety, postoperative pain and patient experience Study Question(s): In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect preoperative anxiety? In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect postoperative pain? In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect patient experience? Study Method: Prospective Experimental Randomized Control Clinical Trial Study Duration: 18 months Study Process: The participants will be recruited through their Pre-surgery interview, at which time a brief explanation will be given on aromatherapy, its potential to reduce preoperative anxiety and postoperative pain, and increase the patient experience. The study design and protocol will also be described. Should the participants elect to participate in this study, they will be randomly assigned using a computer program. Upon arrival for surgery, informed consent will be obtained. Anxiety and pain will be assessed for pre- and post- intervention and just before transferring to the operating room (OR). Upon arrival to the Post-Anesthesia Care Unit (PACU), pain will be assessed in 15-minute intervals until discharge. Anxiety will be reassessed at discharge. Experience will be assessed 2 weeks after discharge. Data Analysis: A one-way Multivariate Analysis of Variance (MANOVA) will be used to assess the impact of aromatherapy on pain, anxiety, and satisfaction. Conclusions: This study aims to add to the body of knowledge of how the incorporation of aromatherapy can impact patient outcomes.

Type: Interventional

Start Date: Jul 2026

open study

This study examines whether participating in poetry workshops can improve emotional well-being among patients with chronic digestive symptoms. Many individuals with long-standing digestive conditions experience distress, anxiety, isolation, and difficulty expressing their emotions in clinical settings. These emotional challenges can negatively affect daily life, relationships, and overall health. Poetry writing offers a creative and supportive way for participants to explore their feelings, express their experiences, and build emotional resilience. It also allows individuals to focus on aspects of their identity beyond their illness. The purpose of this research is to evaluate whether poetry workshops can reduce anxiety, lessen feelings of isolation, and strengthen participants' sense of community and well being. 1. Why is this study being done? The purpose of this research study is to offer a creative outlet for patients to explore their identity and story, build resilience, and seek hope. This study is being done because we understand that the psychological discomfort that can come upon hearing a diagnosis can lead to increased anxiety levels, negatively impacting a patient's well-being and relationships. Often healthcare practitioners may merely view a patient through the lens of their diagnosis, neglecting other aspects of their identity and humanity. Through reading various poems, crafting their own poems, and sharing their work with their peers, we hope the workshops offer a comforting opportunity for the participants to explore their identities and creativity.

Type: Interventional

Start Date: Jul 2026

open study

The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder [MDD] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).

Type: Interventional

Start Date: Jul 2026

open study

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are: - Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns? - Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being? This is a single-arm pilot study without comparison group. Participants will: - Participate in the 6-8 week SanaMente peer-led group program. - Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction. - Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Type: Interventional

Start Date: Mar 2026

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 is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

Type: Interventional

Start Date: Jun 2026

open study

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.

Type: Interventional

Start Date: Apr 2025

open study

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Type: Interventional

Start Date: Apr 2025

open study

Osteoarthritis (OA) is a major public health problem, and involvement of the knee is especially disabling. Symptomatic knee OA has an incidence rate between 40 to 1,020 per 100,000 person years1 and is among the most common causes of disability worldwide. Knee arthritis pain and disability are highly comorbid wiht depression (30-50%). Currently available treatments offer only limited relief. The Pilot project aims to establish feasibility of the rTMS neuromodulation of response to Tai Chi and improvement in pain and comorbid depression in patients with knee OA. There are several ways in which the pilot project will improve scientific knowledge, and clinical practice: 1) The sequential stimulation of two targets (M1 and l-DLPFC) has not been systematically examined for the treatment of comorbid MDD and knee OA. We hypothesize that using a multi-target rTMS strategy combining M1 and l-DLPFC- active targets will be well tolerated and more effective to treat comorbid symptoms than single site rTMS to M1+l-DLPFCsham. This hypothesis will be tested in Aim 1 of this proposal by comparing two experimental conditions: A) M1active and l-DLPFCactive; and B) M1active and l-DLPFCsham. 2) Identifying the relationship between improvement in pain and depression to improvement in pro-inflammatory cytokines would be novel. Adding an rTMS as a neuromodulation technique with novel stimulation sites to assist in the reduction of symptoms of pain and depression is another scalable to clinical use opportunity that will provide pilot data for future clinical trials. We will perform a pilot feasibility trial of rTMS for those presenting with knee osteoarthritis related pain and moderate to severe depression in 30 volunteers who are undergoing Tai Chi intervention. Tolerability and safety of rTMS added to Tai Chi will be assessed along with changes in symptoms of pain and depression, in preparation to future R-01 applications.

Type: Interventional

Start Date: Jun 2026

open study

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Type: Interventional

Start Date: May 2025

open study

The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.

Type: Interventional

Start Date: Aug 2026

open study

This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.

Type: Observational [Patient Registry]

Start Date: Jan 2024

open study

The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses. This study has two primary objectives. 1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure. 2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure. 80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: - How well the treatment helps with symptoms of depression (effectiveness), - How comfortable and willing people are to use the treatment (acceptability), and - How well people can deal with any side effects from the treatment (tolerability). The study will also examine factors that may predict which treatment works better for certain patients.

Type: Interventional

Start Date: Jan 2025

open study