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Depression clinical trials

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NCT ID: NCT05700760 Not yet recruiting - Clinical trials for Postpartum Depression

The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

ROSES-II
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents ~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

NCT ID: NCT05699525 Not yet recruiting - Depression Clinical Trials

Personalized Mobile Cognitive Behavioral Therapy Application

Start date: January 2023
Phase: N/A
Study type: Interventional

This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional magnetic resonance imaging (MRI) and electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.

NCT ID: NCT05699226 Not yet recruiting - Depression Clinical Trials

Amplitude Titration to Improve ECT Clinical Outcomes

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT: H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2). H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency

NCT ID: NCT05698589 Not yet recruiting - Depression Clinical Trials

COMpassion for Psychiatric Disorders And Self-Stigma

COMPASS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma. In this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.

NCT ID: NCT05698394 Active, not recruiting - Clinical trials for Postpartum Depression

Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

Start date: June 19, 2020
Phase: Phase 4
Study type: Interventional

Postpartum depression refers to the depression after childbirth, which is a common mental disorder in women. The pathogenesis of postpartum depression is not fully understood, and may be related to a variety of factors. Prenatal depression is an important risk factor for postpartum depression. Our recent multicenter randomized controlled trial, "Effect of Low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous infusion of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The preliminary results showed that it reduced the incidence of postpartum depression at 42 days. Since there were no studies on the effect of intravenous esketamine infusion after delivery on long-term postpartum depression, this study is a long-term follow-up of the previous randomized trial. We aim to explore the effect of low-dose intravenous esketamine after delivery on the incidence of 2-year maternal depression after delivery in women with prenatal depressive symptoms.

NCT ID: NCT05698381 Recruiting - Depression Clinical Trials

Daily Vinegar Ingestion and Metabolic Health

Start date: February 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.

NCT ID: NCT05697835 Not yet recruiting - Depression Clinical Trials

Perioperative Mental Health in Orthopedic Surgery

CPMH
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.

NCT ID: NCT05697627 Not yet recruiting - Depression Clinical Trials

Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Start date: January 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to determine how cognitive control training (CCT) changes behavior in youth with subclinical depressive symptoms. This research will show what types of behavior changes are important for CCT to help reduce depressive symptoms. In the future, we will use this information to try to improve how we prevent the development of depression, so that it can help more patients.

NCT ID: NCT05697172 Recruiting - Clinical trials for Major Depressive Disorder

Low Intensity Ultrasound Neuromodulation of Repetitive Negative Thinking In Depression

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The investigators propose to use low-intensity transcranial focused ultrasound (LIFU), a novel neuromodulation method, to probe the causal involvement of individually defined components of an anteromedial brain circuit in the processing of self-referential thoughts, and the production of repetitive negative thinking (RNT), a prominent transdiagnostic manifestation with adverse clinical consequences. The investigators hypothesize that real vs. sham low-intensity sonication of individually-defined anteromedial structures connecting medial orbitofrontal and anterior cingulate cortices with ventral striatum and anterior thalamus will show reduced initiation or maintenance of RNT as measured by (1) Brief State Rumination Inventory (BSRI) scores and distress associated to repetitive negative thoughts, and (2) improvement of the affective valence associated to self-referential adjectives, and that these changes will be associated with decreased connectivity between structures mentioned above. The present early feasibility study is an initial step that aims to determine its feasibility and help with the planning of a larger study addressed at actual hypothesis testing.

NCT ID: NCT05697094 Not yet recruiting - Depression Clinical Trials

Impact of Meditation on Reducing Stress in Glaucoma Patients During COVID-19 Pandemic

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Visually impaired seniors are susceptible to having lower Quality of Life (QOL)1-4. The current situation-specific stressors including the fear of contracting COVID-19, prolonged periods of self-isolation, reduced mobility, greater dependence on caregivers or family members, reduced or no social interactions, inability to visit clinics for non-emergency treatments and surgeries, and financial uncertainty may further deteriorate the QOL of seniors with eye diseases. In this study, patients with moderate glaucoma aged 65 and above will be randomized to Art of Meditation (AOM) plus Treatment as usual (TAU) or TAU alone to assess the changes in Health-related quality of life (HRQoL). Patients in the AOM group will be taught a meditation technique by trained instructors while the patients in the TAU group continue to receive standard of care. It is hypothesized that it's feasible to assess the effects of AOM in a sample of glaucoma patients during COVID-19 pandemic, and that glaucoma patients will experience enhanced QOL, reduced depression and anxiety, and improved sleep quality by participating in the AOM intervention.