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668 active trials for Depression

Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor

Background: Psychological distress affects many people diagnosed with a primary malignant brain tumor (PBT). Distress can include negative feelings such as anger, fear, or sadness. Researchers want to see if a type of therapy called CALM can help. It promotes well-being in people who have cancer that cannot be cured. Objective: To find out if the CALM therapy can help people with a PBT suffering from distress. Eligibility: English-speaking adults ages 18 and older who have a PBT and are taking part in NIH protocol #16C0151. Design: This study will not take place in person. It will be done by smartphone, computer, or tablet. Participants will fill out 7 surveys. The surveys will take 40 to 60 minutes to complete. They are all electronic. They will ask about physical and emotional symptoms, depression, feelings about death and dying, feelings about close relationships, and general well-being. Participants will be assigned to a CALM therapist. They will have 3 to 6 individual therapy sessions in 6 months. Each session will last 45 to 60 minutes. Sessions may be audio recorded. If needed, participants may have extra sessions. CALM includes symptom management and discussions of meaning, purpose, and mortality. Participants may have a family member take part in at least one CALM session with them. After the third CALM session, participants will be asked questions about CALM. After 3 and 6 months, participants will complete the 7 surveys again. Participation will last about 6 months.

Start: June 2021

Safe Mothers, Safe Children Initiative

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.

Start: May 2021

Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen

People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future.

Start: June 2021

Compassion Meditation vs. Health Education for Veterans

Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. CP with psychological comorbidity is associated with increased healthcare costs, medication use, risk of suicide and rates of disability and reduced quality of life. Current empirically supported treatments do not always lead to substantial improvements (up to 50% of patients drop out or are do not respond to treatment). This project was designed to evaluate the efficacy of a novel intervention for addressing these challenges. Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of among Veterans with CP conditions and psychological comorbidity.

Start: July 2021

Personalized Exercise Therapy and Self-management for Patients With Multimorbidity

Chronic conditions such as knee or hip osteoarthritis (OA), chronic obstructive pulmonary disease (COPD), heart failure (HF), coronary heart disease (CHD), hypertension, type 2 diabetes mellitus (T2DM) and depression are among the leading causes of global disability and affect hundreds of millions of people around the world. In recent years, multimorbidity, commonly defined as the co-occurrence of at least two chronic conditions, has also gained interest due to its substantial impact on the person and society. Despite the significant burden of multimorbidity, little is known about how to treat this effectively. A 2016 Cochrane systematic review found that interventions targeting populations with specific combinations of conditions and addressing specific problems such as functional difficulties may be more effective. Exercise therapy is a treatment addressing functional limitations that is a safe and effective treatment of at least 26 chronic conditions, including OA, HF, CHD, hypertension, T2DM, COPD and depression. Furthermore, self-management is increasingly recognized as an essential component of interventions to improve outcomes in patients living with multimorbidity and to support the long-term adherence to exercise. A new systematic review found that exercise seems effective in people with multimorbidity (the conditions included in the current study), however highlighting the need for further high-quality RCTs. The aim of this randomized controlled trial (RCT) is to investigate the effects of a personalized exercise therapy and self-management program in addition to usual care on self-reported, objectively measured and physiological outcomes in people with multimorbidity (i.e. at least two of the following conditions: OA (knee or hip), heart condition (HF or CHD), hypertension, T2DM, COPD and depression). The primary endpoint is 12 months, but 12-week and 6-month follow-ups are included as well and a 12-month health economic evaluation of the program will be conducted. Prior to the RCT, a feasibility trial of 20 people with multimorbidity, all undergoing the personalized exercise therapy and self-management program, will be conducted using the same methods as in the RCT, but primarily focusing on feasibility outcomes (recruitment, retention, adherence to treatment, burden of outcomes, improvements in outcomes, adverse events). This will start recruitment in Feb 2021 and end August 2021. The MOBILIZE project has received funding from several foundations, including the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation program (grant agreement No 801790).

Start: August 2021

Scaling Up Science-based Mental Health Interventions in Latin America

Conduct systematic, multi-site mental health implementation research in both rural and urban primary care settings with a broad group of stakeholders in the US and Latin America.

Start: February 2018

Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population

Internet-Based Interventions are increasingly relevant as an alternative for reducing the gap in treatment of metal disorders such as depression, especially in resource-limited regions. In this study the investigators will try to evaluate the effectiveness of an Internet-Based Intervention culturally adapted to the Ecuadorian population for treatment of depression.

Start: October 2020

A Virtual Navigation Intervention to Reduce Behavioral Health Admissions From Rural Emergency Departments

This research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a BH-VPN program among patients with a telepsychiatric consult. The outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

Start: October 2019

Brief, High-dose rTMS for Depression

High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.

Start: June 2021

Latinx Teen Depression Treatment Study

The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.

Start: April 2021

A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.

Start: April 2021

RCT of Adjunctive Curcumin and the Meru Health Program

This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.

Start: February 2021

Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.

Start: July 2021

Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial

The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) pragmatic clinical trial will test the population-level implementation of validated approaches to detect and effectively manage sleep disturbance, pain, anxiety, depression, energy deficit/fatigue, and functional decline among patients with all types and stages of cancer using a cluster-randomized, stepped wedge design.

Start: March 2019

Angiotensin Agents and Reduction of Prescription of Antidepressant Drugs

A retrospective cohort study will be performed by analyzing data obtained from the Southern Metropolitan Territorial Management's database, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in three groups ("ARBs" group; "ACEIs" group; "Non-ARBs and Non-ACEIs" group). Afterwards, a subgroup analysis will be carried out to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs. The primary outcome is to provide evidence of whether the usage of angiotensin agents associates with a reduced antidepressant drugs prescription. As secondary outcomes, the investigators will estimate, on each of these groups, how many patients are receiving treatment with both an antihypertensive and an antidepressant drug; how many patients receiving both treatments had the antidepressant drug withdrawn; and how many patients receiving an antihypertensive drug, but no antidepressant drug, had started treatment with an antidepressant drug.

Start: March 2021

Meru Health Program Versus Waitlist Control for Adults With Depression

This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression. The Meru Health Program (MHP) is a 12-week mobile mental health intervention delivered via Smartphone app that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback [HRVB], nutritional psychiatry, sleep training) that is overseen by a licensed clinical therapist.

Start: August 2020

Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.

Start: November 2018

Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2

Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

Start: March 2021

Treatment of Early Childhood Depression

Depression often occurs in early childhood. Moreover, later depression is frequently preceded by early childhood Depression (ECD). However, at present, there is a lack of evidence-based tratestments (EBTs) for ECD, posing a core research desideratum highlighted by both the American and German practice parameters for ECD. The current study seeks to redress this research gap, by evaluating the feasibility and dose-dependent effectiveness of manualized short-term psychoanalytic child psychotherapy (PaCT) compared to waitlist in a randomized controlled trial (RCT) among clinically referred 3 to 8-year-olds with ECD. Comprising 20-25 sessions in alternating settings (child-only, caregiver(s)-child, caregiver(s)-only), PaCT focuses on internal conflicts and representations underlying depressive disorders. PaCT targets the child-therapist relationship, using interpretative, play and mentalization-based techniques, aiming to elicit the interpersonal meaning of the child's symptoms within the child-caregiver relationship(s).

Start: February 2020

Depression Screening in Black Churches

The overall aim of this study is to employ Community Health Workers (CHWs) to screen for depression in 30 Black churches and compare the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) (Intervention arm) to Referral As Usual (Control arm) on treatment engagement for depression. The investigators will assess patient-level outcomes (Mental-Health Related Quality of Life and depressive symptoms) at 3- and 6-months post-screening and conduct a mixed-methods process evaluation to assess multi-level facilitators and barriers of screening uptake.

Start: June 2021