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Depression, Anxiety clinical trials

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NCT ID: NCT05493865 Not yet recruiting - Depression, Anxiety Clinical Trials

Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems

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

Depression and anxiety are common mental health problems among adolescents worldwide. In Hong Kong, one in every four secondary school students reports clinical-level depression or anxiety symptoms. Extant research has found that a fixed mindset on intelligence and emotions and failure-is-debilitating belief are closely related to more depression and anxiety symptoms, hopelessness and suicidality. At the same time, recent research also points to the importance of parental mindset. Parents are the primary social support of adolescents; parental belief systems can strongly influence children's affect, behaviour and mental health. However, the effects of parent-child mindset interventions on a child's internalising problems have not yet been empirically examined. As emerging evidence has shown the promise of single-session interventions on reducing and preventing youth internalising problems, this project develops and examines a parent and child single-session intervention on mindsets of intelligence, failure and emotion (PC-SMILE) - to tackle depression and anxiety in young people and promote parental well-being. Using a two-arm randomised controlled trial, the proposed study will examine the effectiveness of PC-SMILE on reducing depression and anxiety symptoms among children, reducing parental anxiety, enhancing perceived control and parent-child relationships. A total of 366 parent-child dyads will be recruited from eight secondary schools and randomly assigned to either the PC-SMILE intervention group or the no-intervention waitlist control group. The PC-SMILE is approximately 45 minutes in length. Parent and child mental health and family relationship will be assessed at three time points: baseline before intervention (T1), within two weeks post-intervention (T2) and three months post-intervention (T3). A pilot test (n = 9) has supported the feasibility and acceptability of the PC-SMILE intervention. We hypothesise that the PC-SMILE intervention will significantly improve child depression and anxiety and parent anxiety (primary outcome) and significantly improve secondary outcomes, including child perceived control over emotion, children's and parents' hopelessness, psychological wellbeing, and parent-child relationships. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis. The project brings together experts in mindset research, family therapy, statistics, youth depression, and psychiatry. The Principal Investigator's strong connection with schools ensures the feasibility of the study. This study will not only provide evidence on parent-child growth mindset intervention for adolescent internalising problems but can also serve as a scalable and accessible intervention for improving the well-being of young people and their parents.

NCT ID: NCT05475535 Not yet recruiting - Stress Clinical Trials

Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.

NCT ID: NCT05348174 Not yet recruiting - Depression, Anxiety Clinical Trials

Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Introduction Patients with advanced cancer often experience high levels of debilitating pain and pain-related psychological distress. Although there is increasing evidence that non-pharmacological strategies are needed to treat their pain, pharmacologic modalities remain the preferred strategy. Guided imagery is a form of focused relaxation that helps create harmony between the mind and body and has been shown to significantly improve cancer pain. This study presents Virtual Reality Assisted Guided Imagery (VRAGI) as an alternative pain treatment modality. The investigators of this study will conduct a randomized control trial to test its efficacy, feasibility, and safety in the home setting, for patients with advanced cancer. Methods and Analysis The study will recruit 80 participants from Prisma Health, a tertiary level health care center based in Greenville, South Carolina, USA using a stringent set of inclusion and exclusion criteria. The prospective 6-week, 2x2 randomized controlled trial will randomize participants to four groups: (1) VRAGI, (2) Laptop Assisted Guided Imagery (AGI), (3) VR (no guided imagery or other audio), and (4) laptop (no guided imagery or other audio). Participants allocated to VR groups will be trained to use a head-mounted display (HMD) that immerses them in 3D audio-video content. The non-VR group will use a laptop displaying 2D video content. Content includes relaxing natural scenes across three calendar seasons (spring, summer, fall). Investigators will collect measures pre, during, and post intervention including patient reported outcomes (PROs) of pain, anxiety, depression, fatigue. Additionally, investigators will assess the feasibility, acceptability and safety of VRAGI use in a home setting. Trial Registration Number #Pro00114598 Strengths and Limitations - This study uses a novel design that combines the use of immersive Virtual Reality (VR) technology with guided imagery processes to treat chronic pain in advanced cancer patients. - Investigators propose a reproducible intervention that can be self-administered in a home setting, thus eliminating the need for trained personnel, transportation modalities, or healthcare facilities. - VR content will be preloaded onto HMDs, thus eliminating the need for access to the internet and decreasing the variability of the intervention. - Investigators will collect patient reported outcomes (PROs) on pain, anxiety, depression, fatigue, and opioid use, but not continuous user feedback or biofeedback. - This study focuses on patients < 65 years of age with advanced cancer. This allows the study to focus on a large group of patients but may limit the overall generalizability of the findings.

NCT ID: NCT05276479 Not yet recruiting - Stress Clinical Trials

Dietary Plant Hormone and Mental Health

Start date: April 1, 2022
Phase:
Study type: Observational

The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects.

NCT ID: NCT05242003 Not yet recruiting - COVID-19 Clinical Trials

Assessing the Safety and Efficacy of MYMD1 to Treat Depression in Patients With Post-Acute Sequelae of Coronavirus Disease-2019 (PASC)

Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, Double-Blind, Randomized, Placebo-Controlled Study to evaluate the effects of the drug MYMD1, a novel Immuno-Metabolic Regulator, for its antidepressant and antianxiety properties, in addition to its anti-inflammatory effects, in patients with Post-Acute Sequelae of Coronavirus Disease-2019. The investigators' hope is that this drug will help treat the depressive and anxiety symptoms in post-COVID-19 patients and any post-COVID-19 inflammatory complications. The total duration of the study will be a maximum of 40 days-involving enrollment (1 day), an active treatment phase (10 days) during which participants will either receive 300mg of MYMD1, 600mg of MYMD1, or a placebo, and a remote monitoring phase (28 days).

NCT ID: NCT04914104 Not yet recruiting - Stress Clinical Trials

Accessible Support in Surgical Training During a Pandemic Study

ASSIST
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The COVID-19 pandemic has fundamentally changed the surgical trainee experience by exacerbating the difficulty of this notoriously stressful training, while limiting access to traditional avenues of mental health support. The investigators propose the application of a mobile app-based mindfulness program to address stress and burnout in the surgical training. The proposed study is a prospective randomized, observer-blinded study including surgical trainees at the University of Ottawa in their first and second years of training. The intervention group will receive free access to the mobile app Headspace and will be encouraged to access the app three times a week for 15 minutes.

NCT ID: NCT04909749 Not yet recruiting - Depression, Anxiety Clinical Trials

CDDOM Oneome Rightmed Depression Study

Start date: June 2021
Phase: N/A
Study type: Interventional

In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care. Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population.

NCT ID: NCT04559360 Not yet recruiting - Depression, Anxiety Clinical Trials

Development, Feasibility and Effectiveness of a Digital Support Platform for Mental Health in Primary Care (PRESTO).

PRESTO
Start date: December 2021
Phase: N/A
Study type: Interventional

The prevalence of mental health disorders in Primary Care (PC) largely exceeds the limited resources available. The main aim of this project is to develop a comprehensive machine learning (ML) digital support platform (PRESTO) to approach people with mental health symptoms in PC. PRESTO will offer a transdiagnostic triage of those cases needing specialized care while most of the mild and moderate cases with anxiety and depressive symptoms will be allocated through ML models to either: 1.a periodic follow-up, 2.symptoms monitoring and brief psychological intervention with a smartphone app, or 3.a specific psychopharmacological treatment. To reach this objective, first, a ML predictive severity model will be build based on all the cases referred to the PC mental health support programme during the last 5 years retrieved from electronic health records from 5 PC centres(PCC) in Barcelona. Simultaneously, a smartphone app (PRESTOapp) monitoring symptoms and delivering a psychological intervention for non-severe anxious and depressive symptomatology will be developed and tested in a feasibility study and in a randomized clinical trial. Finally, the ML models obtained from the first phase of the project and the data from the PRESTOapp study will be integrated in a comprehensive self-learning web platform which will triage and assign to each case a specific intervention based on the predicted outcome. The effectiveness of PRESTO to reduce waiting times in receiving appropriate and specific care of mental health problems will be tested by means of a stepped-wedge randomized controlled trial in 5 PCCs in Barcelona. Here we register a Randomized controlled clinical trial with PRESTOapp 2.0 detailed afterwards:

NCT ID: NCT04524039 Not yet recruiting - Multiple Sclerosis Clinical Trials

iTBS Study for Depression in Patients With Multiple Sclerosis

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Depression not only reduces the response to treatment, delays the recovery of neurological function and social ability, but also significantly increases the risk of disability in patients with MS. Transcranial magnetic stimulation (TMS) is a non-invasive method of brain stimulation that is based on electromagnetic induction. Intermittent theta burst stimulation (TBS), a newer form of rTMS, delivers 600 pulses in just 3 min, versus 37.5 min for conventional rTMS, but it has been shown to produce similar effects in patient with treatment-resistant depression. To observe the effect and safety of iTBS on patients with MS and depression, we design a double-blind, randomized controlled study. Results of this research will inform on the efficiency of the TMS for the treatment of depression in MS patients, which will reduce the risk of disability and improve the quality of life.

NCT ID: NCT04518839 Not yet recruiting - Quality of Life Clinical Trials

The Comparison of Cognition, Depression and Anxiety, and Quality of Life After Hip Fracture Surgery Under General or Regional Anesthesia

Start date: August 2020
Phase:
Study type: Observational

Postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. There is also increased incidence of depression and anxiety. Both affect the recovery after surgery, slow it down and reduce the quality of life. Patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. Patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.