Anxiety & Depression Association of America

This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

Type: Observational

Start Date: Sep 2024

open study

The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main question it aims to answer are: Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? Researchers will compare brain scans and rumination scores before, during, and immediately after TMS. Participants will: Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task

Type: Interventional

Start Date: Jan 2024

open study

This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety. This is a randomized research study and subjects will be randomized into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups: 1. Swedish massage therapy twice per week for 6 weeks. 2. Light touch therapy twice per week for 6 weeks. The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder. Subjects will undergo two fMRI scanning sessions (one before and one after) twice per week for 6 weeks of touch intervention. Subjects will also be asked to complete questionnaires on anxiety, stress and depression.

Type: Interventional

Start Date: May 2024

open study

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Type: Interventional

Start Date: Sep 2024

open study

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.

Type: Interventional

Start Date: Oct 2024

open study

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.

Type: Interventional

Start Date: Apr 2024

open study

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

Type: Interventional

Start Date: Jan 2025

open study

This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.

Type: Interventional

Start Date: Feb 2024

open study

This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations

Type: Interventional

Start Date: Jun 2023

open study

This research study is being done to investigate if the GH Method exercise program positively affects body composition, improves physical abilities and can improve the overall sense of wellbeing (e.g. depression, PTSD, etc.) in U.S. Veterans. Subjects will be asked to complete 94 total visits (four (4) study testing visits and 90 exercise visits). Enrolled subjects will be tested for fitness, strength, and health risk factors at UIC 4 times and will complete 90 exercise training visits at the GH FITLab over the next 18 months. Subjects will also be asked to complete questionnaires about depression, post-traumatic stress symptoms and thoughts about harming oneself.

Type: Interventional

Start Date: Oct 2021

open study

We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following specific aims: Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability of bezafibrate added to anti-manic medication for bipolar depression, especially with regard to worsening manic symptoms and suicidal ideation. We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to FDA-approved anti-manic medication in 30 participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the Framingham Cardiovascular Risk Score. Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of bezafibrate added to anti-manic medication for acute bipolar I major depressive episodes. Hypothesis: The bezafibrate group will have a statistically significant decrease in the Montgomery Asberg Rating Scale (MADRS) Scores over 8 weeks. The results of this proof-of concept phase IIa study will help us to plan a placebo-controlled randomized trial. In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR agonist, bezafibrate, for 30 patients with an acute bipolar I major depressive episode. The study may have a profound impact on the development of a novel treatment consistent with the mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge, will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.

Type: Interventional

Start Date: Jan 2018

open study

This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.

Type: Interventional

Start Date: Jul 2025

open study

This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.

Type: Interventional

Start Date: Aug 2025

open study

The goal of this trial is to compare the impact of two outreach strategies (high touch vs. standard outreach) on a collaborative care program delivered via telehealth to patients with lung cancer.

Type: Interventional

Start Date: Aug 2025

open study

The goal of this randomized clinical trial is to learn if tai chi/qigong decreases depressive symptoms among older people living with HIV compared to a health education class. The main questions it aims to answer are: Does tai chi/qigong reduce depressive symptoms among older people living with HIV more than a health education class? What are the behavioral, psychological, and biological mechanisms in which tai chi/qigong affects depressive symptoms? Does tai chi/qigong affect depressive symptoms among older people living with HIV differently for men compared to women? Researchers will compare a 12-week, twice a week remotely delivered tai chi/qigong intervention to a health education class of the same duration to determine if it improves depressive symptoms among older people living with HIV. Participants will: Attend either a tai chi/qigong class twice a week for 12 weeks or a health education class of the same duration delivered via Zoom. Each class will be 45-60 minutes in length. Participate in 3 separate interviewer-administered interviews: at the time of enrollment, 3 months after the last class, and 9 months after the last class. Keep a tracking log of their home practice of tai chi/qigong (only participants in the intervention group). Use a biosensor (an earlobe sensor or chest strap) to measure their heart variability. Go to their local lab (e.g., Quest or Labcorp) for blood draw at the time of enrollment and at 9 month post intervention (this will only be a subset of participants).

Type: Interventional

Start Date: Aug 2025

open study

The purpose of the study is to conduct an initial test of the efficacy of Emotional Resolution (EmRes) therapy to reduce anxiety in healthcare workers. The investigators hypothesize EmRes will reduce levels of anxiety in participants compared to an active control group engaged in mindfulness-based gratitude.

Type: Interventional

Start Date: Oct 2024

open study

The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.

Type: Interventional

Start Date: Jun 2023

open study

Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this randomized trial is to conduct a fully powered effectiveness trial of video-delivered PROTECT (Tele-PROTECT) compared to a video-delivered depression education (DepEd) control condition to be delivered to 140 English- and Spanish-speaking NYC elder abuse victims. Investigators hypothesize three main aims: 1. Effectiveness Aim: Tele-PROTECT participants will have significantly greater and clinically meaningful reductions in depression when compared to the DepEd control; 2. Abuse Impact Aim: Tele-PROTECT participants will demonstrate greater safety related empowerment compared to DepEd control, which can help participants take steps to reduce risk; 3. Implementation Aim: Stakeholders' views of the factors impacting the implementation of Tele-PROTECT based on characteristics of the intervention, agency setting, and population served will contribute to a national dissemination of Tele-PROTECT Participants will - Receive 9 weeks of tele health psychotherapy delivered by a Master's level mental health clinician from the Weill Cornell Medicine research team. Participants will be assigned to "Tele-PROTECT" or "DepEd" psychotherapy randomly. - Participate in one baseline assessment and four follow-up assessments at weeks 3, 6, 9, and 12 administered by a trained member of the research team.

Type: Interventional

Start Date: Sep 2023

open study

This research is being done to find if there are changes with voice and speech during episodes of mania.

Type: Interventional

Start Date: Apr 2023

open study

Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Rumination is known to be associated with the default mode network (DMN) region activity. Implementing the Dependency Network Analysis (DEPNA), a recently developed method by the research team to quantify the connectivity influence of network nodes, found that rumination was significantly associated with lower connectivity influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This study implements the first real-time fMRI neurofeedback (Rt-fMRI-NF) network-based protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD to reduce rumination levels. This will allow for more accurate explicit brain connections modulation than the standard single brain region activity; creating a larger opportunity for target clinical neuromodulation treatment in individuals with MDD.

Type: Interventional

Start Date: Jul 2023

open study

This is a three-armed clinical trial examining the effect of 5-hydroxytryptophan and creatine monohydrate as augmenting agents for the treatment of depression. Subjects will be randomized between 5-HTP 100mg BID + creatine 5g daily, 5-HTP 200mg BID + creatine 10g daily, vs double placebo, for 8 weeks. The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosphorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels.

Type: Interventional

Start Date: Sep 2023

open study

The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).

Type: Interventional

Start Date: Jul 2025

open study

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

Type: Interventional

Start Date: Sep 2023

open study