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Depression clinical trials

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NCT ID: NCT04109716 Active, not recruiting - Depressive Symptoms Clinical Trials

School Adolescent Mood Project: Efficacy of IPT-AST in Schools

SAM
Start date: August 15, 2019
Phase: N/A
Study type: Interventional

This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b) examine moderators and mediators of intervention effects, and c) assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of IPT-AST.

NCT ID: NCT04106466 Active, not recruiting - Clinical trials for Major Depressive Disorder

DBS for TRD With the Medtronic Summit RC+S

Start date: January 21, 2020
Phase: N/A
Study type: Interventional

Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care. By using an experimental prototype DBS device called the Summit RC+S (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS. The study team will recruit 10 patients with TRD and implant them with the Summit RC+S system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and periodic EEGs (scalp brainwave recordings). A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the device will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 10 years, which is the expected life of the battery that powers the device. All participants are required to live in the New York metropolitan area for the first two years of the study.

NCT ID: NCT04089085 Active, not recruiting - Childhood Asthma Clinical Trials

STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.

NCT ID: NCT04084795 Active, not recruiting - Anxiety Clinical Trials

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Start date: September 25, 2019
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is Multifocal transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 45 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to MtCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.

NCT ID: NCT04072185 Active, not recruiting - Depression Clinical Trials

PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

Background: Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly of our society. This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these situations, since sometimes pharmacological options are limited in these patients. Physical activity (AF) and social relationships in the elderly are linked to physical and mental health. Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way, however, few studies have evaluated their effectiveness in our territory. - Objectives: To evaluate whether a 4 month AF group program and the visit to know socio-cultural entities improve the emotional, social and quality of life situation in a sample of people over 64 years of age with anxiety, depression, social isolation or solitude And measure whether adherence to AF and the linkage to sociocultural entities is maintained after the intervention has taken place. - Methodology: Design: Multicentre, randomized, two-group clinical trial, of 1 year follow-up. Study population: Patients over 64 years of age assigned to primary care teams (EAP) from different locations: Sant Joan de Vilatorrada, Súria and Manresa 2. Inclusion criteria: To meet criteria of depression or anxiety at the time of the study, score> 12 on the Beck Depression Scale and / or score> 10 on the GAD-7 Scale (General Anxiety Disorder) and that Present a score <32 on the steps of DUKE-UNC-11. A randomization of between 44 and 56 patients will be performed at each participant EAP. Half will be allocated to the control group (GC) and half to the intervention group (GI). The intervention group will participate in a group AF program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection. . Main measures: Response to the intervention or clinical remission of depression (Escalera de Beck), and / or anxiety (Escala GAD-7), improvement of social support (DUKE-UNC) and quality of life (EuroQol) . Secondary measures: Adherence to the AF (VREM questionnaire (Spanish Reduced Version of the Minnesota Free Time Questionnaire in Minnesota)), and linkage to sociocultural entities once the intervention has been completed. The assessments will be made at 0, 4, 8 and 12 months.

NCT ID: NCT04070417 Active, not recruiting - Depression Clinical Trials

Lifestyle Medicine for Depression 2019

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This study will examine the feasibility and efficacy of lifestyle medicine for the enhancement of psychological wellness in adult. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, sleep and socialisation. These components are weaved with psychological elements such as stress management, cognitive restructuring, motivational interviewing, and goal setting strategies that are led by clinical psychologists. While lifestyle medicine has been recognised for centuries a a mean to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. Nevertheless, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g. diet, physical activities, and sleep) on mood and stress management. With a well-researched lifestyle medicine programme adopted from Australia, the research team of the Chinese University of Hong Kong has customised the intervention protocol to fit the Chinese culture. The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on depression from a holistic body-mind perspective.

NCT ID: NCT04018391 Active, not recruiting - Depression Clinical Trials

Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

Start date: July 12, 2019
Phase: N/A
Study type: Interventional

A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.

NCT ID: NCT04011163 Active, not recruiting - Pain Clinical Trials

Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain

VPIA
Start date: March 31, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

To meet the unmet need of better and safer pain relief for acute pain in the post-operative setting, a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia ("VPIA") Delivery System, with novel and intelligent software algorithms and specialised hardware was developed. In the previous project, the investigators have shown that this system has the potential to increase the safety and patient satisfaction with intravenous opioid analgesia. However, opportunities to develop more robust vital signs monitoring with the goal of ensuring continual and effective analgesia are identified. The primary aim of this proposal is to advance the development of technology (through new features and functionality) and perform clinical evaluation of the VPIA system with a larger sample size to show improvements in patient's satisfaction (pain relief) and robustness of system in terms of vital signs integration. Novel technology using adaptive vital signs controller, integrated with an infusion pump and single finger probe vital signs monitor system will be developed with the aim for commercialisation.

NCT ID: NCT04010643 Active, not recruiting - Depression Clinical Trials

Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy

OPTM
Start date: October 24, 2018
Phase: N/A
Study type: Interventional

To evaluate the clinical efficacy of online cognitive behavioural therapy supplemented with online neurocognitive remediation therapy to improve mood and cognition, decrease relapse rates and optimise work and occupational functioning.

NCT ID: NCT04007666 Active, not recruiting - Depression Clinical Trials

Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that address the needs of the criminal justice system. The proposed research will be conducted as part of Dr. Zielinski's Mentored Patient-Oriented Research Career Development Award (K23), which aims to: 1) advance knowledge on implementation of a gold-standard psychotherapy for trauma, Cognitive Processing Therapy (CPT), in the prison setting and 2) examine whether prison-delivered CPT reduces drug use, psychiatric symptoms, and recidivism compared to a control condition (a coping-focused therapy). These foci have been selected because severe trauma exposure, substance use, and justice-involvement overwhelmingly co-occur in prison populations. The three specific aims in this research are: 1) Use formative evaluation to identify factors that may influence implementation and uptake of CPT in prisons, 2) Adapt CPT for incarcerated drug users and develop a facilitation-based implementation guide to support its uptake, and 3) conduct a participant-randomized Hybrid II trial to assess effectiveness and implementation outcomes of CPT with incarcerated drug users. Participants will include people who have been incarcerated (pre- and post-release from incarceration) and prison stakeholders who will be purposively sampled based on their role in implementation of CPT and other programs. Anticipated enrollment across all three Aims is 244 adult men and women.