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Depression clinical trials

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NCT ID: NCT06468020 Not yet recruiting - Gamification Clinical Trials

The Gather: Town Gaming Intervention for Depression Management

Start date: December 2024
Phase: N/A
Study type: Interventional

Aim This study aims to explore the experience of depression among pregnant adolescents in Thailand and assess the effectiveness of the Gather.town gaming intervention for relieving depressive symptoms. Methods The study will adopt an exploratory sequential mixed-methods design. It comprises two phases: a qualitative and a quantitative sub-study to answer the research questions. Phase one is a qualitative sub-study to gain a comprehensive understanding of the experiences of pregnant adolescents with depression and their perceptions of interventions for relieving depressive symptoms. This sub-study will conduct in-depth interviews and content analysis with 20 pregnant adolescents selected through purposive sampling from an antenatal care clinic. The interview results will be used to develop the Gather.town gaming intervention for depression management. Phase two is a quantitative sub-study conducted through a quasi-experimental design with 64 participants, divided into an intervention group of 32 and a control group of 32. Convenience and snowball sampling will be performed. The effect of the oGBL intervention will be evaluated on the primary outcome of depression symptoms/levels and secondary outcomes including knowledge of depression, coping skills, perceived social support, and help-seeking attitudes. Initial feedback from users on the Gather.town gaming intervention will also be examined. Data will be collected using self-report questionnaires and open-ended questions. Assessments will be conducted at four time points: baseline, after the intervention, and at the 1-month and 3-month follow-ups. Descriptive statistics, Chi-square tests, and ANCOVA will be used for data analysis. Finally, data from the qualitative and quantitative sub-studies will be merged to interpret the effects of the Gather.town gaming intervention for depression management among Thai pregnant adolescents.

NCT ID: NCT06467695 Not yet recruiting - Parkinson Disease Clinical Trials

Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

LVESDIPP
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

NCT ID: NCT06464445 Not yet recruiting - Neuromodulation Clinical Trials

Optimization of iTBS for Depression

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression. Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied. The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.

NCT ID: NCT06462638 Not yet recruiting - Preterm Birth Clinical Trials

COntact RElationship in Neonatal Intensive Care Unit

CORE in NICU
Start date: November 1, 2024
Phase:
Study type: Observational

The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice. The study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse. These behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and/or anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents/nurses who interact with them through voice and touch. The research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.

NCT ID: NCT06462196 Not yet recruiting - Clinical trials for Major Depressive Disorder

Natural History of Depression, Bipolar Disorder and Suicide Risk

Start date: June 26, 2024
Phase:
Study type: Observational

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....

NCT ID: NCT06461637 Not yet recruiting - Depression, Anxiety Clinical Trials

Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers

Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trials is to assess the effectiveness of the stepped care approach in treating common mental disorders among foreign domestic helpers in Hong Kong and improve their access to evidence-based psychological treatments. Participants will be required to complete an online consent form. Then, around 240 eligible participants aged 18-65 years with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) and/or anxiety (Generalized Anxiety Disorder-7 [GAD-7] ≥ 8) will be randomly assigned to the intervention and control group in a ratio of 1:1. Participants assigned in the intervention group will recieved the stepped-care mental health intervention while those assigned to the control group will receive care-as-usual. Assessments of depression, anxiety, and insomnia symptoms, as well as work and social adjustment, quality of life, and treatment credibility and acceptability will be conducted at baseline, week 7 (after Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up). An assessment of barriers to accessing care will also be collected before treatment.

NCT ID: NCT06458192 Not yet recruiting - Depression Clinical Trials

Adaptive Messaging to Support Depression Self-Management

Start date: June 2024
Phase: N/A
Study type: Interventional

This is a pilot randomized controlled trial of an adaptive 8-week text messaging intervention for depression self-management. Among 100 individuals with elevated depression symptoms, we will compare the effects of 8 weeks of the adaptive text messaging intervention (n=40) to 8 weeks of a non-adaptive text messaging intervention (n=40), and 8 weeks of a psychoeducation-only intervention (n=20). We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained. Both messaging arms will receive 8 weeks of daily text messaging. Messages will prompt learning and applying cognitive and behavioral self-management strategies. Whereas the non-adaptive messaging system will randomly select daily messaging styles (representing a variety of self-management strategies and message tones), the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement. Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm (if applicable). The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information. We will recruit participants through digital methods (e.g., advertising on social media platforms like Facebook and Instagram). Administration of study measures will occur at baseline, weeks 4 and 8, and 3-month and 6-month follow-up. The primary outcomes is depression symptom severity (PHQ-9). Secondary outcomes are: anxiety severity (GAD-7) and suicidality (DSI-SS). Using an Intention to Treat paradigm, we will test our hypothesis that: H1: Relative to the psychoeducation-only control, messaging interventions will reduce depression (H1a) and anxiety and suicidal ideation (H1b). H2: Relative to non-adaptive messaging, adaptive messaging will reduce depression (H1a) and anxiety and suicidality (H2b). H3: Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement.

NCT ID: NCT06456307 Not yet recruiting - Depression, Anxiety Clinical Trials

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

IPMH
Start date: January 2025
Phase: N/A
Study type: Interventional

Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.

NCT ID: NCT06455527 Not yet recruiting - Depression Clinical Trials

Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (RS) tDCS protocol. Enrolled participants will complete 10 days of 30-minute tDCS (2.0, DLPFC left anodal) using the RS-tDCS protocol. During each daily session, standard HR and impedance-based HR (i-HR), obtained from the tDCS headset, will be collected to identify a possible marker of response to tDCS in depression. Participants will be randomized 2:1 to active vs. sham tDCS.

NCT ID: NCT06455293 Not yet recruiting - Depression Clinical Trials

Psilocybin Therapy for Depression in Parkinson's Disease

PDP2
Start date: July 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.