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Mental Health Issue clinical trials

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NCT ID: NCT04806542 Completed - Mental Health Issue Clinical Trials

Two-year Follow-up of a Mindfulness-based Intervention in Children.

Start date: January 29, 2016
Phase: N/A
Study type: Interventional

The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up. Methods The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.

NCT ID: NCT04786080 Completed - Mental Health Issue Clinical Trials

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

SPARKLE
Start date: May 19, 2021
Phase: N/A
Study type: Interventional

Throughout the COVID-19 pandemic, reduced access to childcare, money- and health-related worries and extended confinement and social isolation have placed great pressure on many families. There is evidence that many parents in the UK have struggled to manage their children's behaviour. For instance, Co-SPACE, an ongoing UK-wide study led by the University of Oxford, found a significant increase in parents reporting behavioural problems in children and an increase in family-related stress in response to various local and national lockdowns. Co-SPACE has also found up to 70% of parents reported wanting additional support. The SPARKLE (Supporting Parents and Kids through Lockdown Experiences) study aims to address this pressing need. SPARKLE is a rapid-deployment randomised controlled trial evaluating whether a digital public health parenting intervention can help parents to manage their children's behaviour problems, as impacted by the COVID-19 UK pandemic and lockdowns. We aim to evaluate whether the negative effects of the pandemic can by reversed by providing parenting advice digitally, using a specially-designed app, Parent Positive. The Parent Positive app will provide advice to parents through animations, delivering messages carefully selected by parents and experts in the field. The messages will be supplemented with practical parenting resources and an opportunity to network with other parents for peer support. The animations are light-hearted, humorous and non-judgmental and are delivered by eight high-profile celebrities who are also parents. The SPARKLE study will involve 616 Co-SPACE parents, half of whom will receive access to the Parent Positive app and half who won't.

NCT ID: NCT04749264 Completed - Mental Health Issue Clinical Trials

The Influence of Mindfulness Meditation Retreat on Attention to Internal Experience

Start date: August 1, 2020
Phase:
Study type: Observational

Although attention is thought to have a definitive functional role in mindfulness meditation training and its salutary mechanisms of action, extant empirical evidence is mixed and limited. In the proposed study, we propose to test whether 6 to 7-days mindfulness meditation retreats (N=90), relative to a wait-list control condition (N=45), will impact internal attentional processes or attention to internal experience (e.g., thoughts and bodily sensations); and whether these internal attentional change processes predict salutary outcomes of mindfulness meditation retreats. Participants will complete tasks designed to measure attention to internal experience before and then immediately following the retreat, as well as self-report measures of salutary outcomes before and 2-weeks post-retreat. Matched controls will complete the tasks at parallel time-points in the lab.

NCT ID: NCT04672486 Completed - Stress Clinical Trials

PRIDE - Pilot Trial of an Online Digital Problem-solving Intervention for School-going Adolescents in Goa, India

Start date: January 28, 2021
Phase: N/A
Study type: Interventional

This study is part of a Wellcome Trust-funded research programme in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). The programme aims to develop and evaluate a trans-diagnostic, stepped-care intervention targeting common mental health problems in school-going adolescents in India. The study is planned in the context of school closures and other COVID-19 mitigation strategies in India. We will undertake a pilot randomized controlled trial with the specific aims to - assess the acceptability and feasibility of an online problem-solving intervention - obtain effect size estimates for the online problem-solving intervention when compared to a usual care control condition - assess process variables related to intervention and research procedures and thereby assist with planning for a future large-scale trial.

NCT ID: NCT04650906 Completed - Mental Health Issue Clinical Trials

A Feasibility Study for Evaluating the Effectiveness of Mindhelper - a National Youth Mental Health Promotion Website

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The feasibility study will investigate the potential of online recruitment for a randomized trial of the effectiveness of Mindhelper. Recruiting participants for intervention studies is increasingly difficult, as there are many commercials and research projects competing for people's attention. Thus, participation rates in research projects are generally declining. The widespread access to the internet, especially among adolescents, offers a new and attractive alternative strategy to recruit participants for intervention studies. The feasibility study will inform us whether it is possible to recruit young people with mental health problems who are not familiar with Mindhelper and then randomize them to use or not to use the website (block randomization). Furthermore, it is necessary to know whether it is possible to follow the two groups over time and assess relevant outcomes. We aim to answer the following questions: - Is it possible to identify and recruit young persons (15-25 years of age) in need of mental health promotion via social networking sites such as Facebook.dk? - How quickly is it possible to recruit people for the study through networking sites? - Is it possible to ensure that the intervention group uses the Mindhelper website (>75%) and minimize the likelihood that the control group uses it (<25%)? - Is it possible to follow the two groups to obtain information at first follow-up at one week (T2)? The results will inform the study design of the effectiveness study. If the feasibility study shows (i) that it is possible to recruit and randomize young people with mental health problems within a specified period, (ii) that both groups will follow their randomization into either the intervention or control group, and (iii) that it is possible to follow both groups to obtain follow-up data, then the main study will be conducted as an online recruited randomized effectiveness study (online RCT). If the feasibility study shows that the conditions are not ideal for achieving these goals, we will conduct a longitudinal panel study of Mindhelper users comparing different types of users.

NCT ID: NCT04646616 Completed - Covid19 Clinical Trials

CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia.

CRISOL Contigo
Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Latinos have been one of the racial/ethnic groups most impacted by the COVID-19 pandemic, and evidence of effective strategies to curb the pandemic, reduce disparities, and mitigate its impact is lacking and very urgent. The goal of this competitive revision is to expand an ongoing academic-community partnership to adapt, implement, and evaluate a multi-level intervention to mitigate the multi-dimensional toll of COVID19 among Latino immigrant communities in Philadelphia.

NCT ID: NCT04518631 Completed - Mental Health Issue Clinical Trials

Effects of Mindfulness Training on Emotional Care

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

Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to investigate 1) the effects of mindfulness training on teachers' well-being (i.e. general health, positive affect, life satisfaction, stress, negative affect), and 2) the mechanisms underlying the effectiveness of mindfulness (i.e. emotional care strategies including anchoring, decentering, and acceptance). Participants will be randomized to either intervention (8-week .b Foundations/ .begin course) or waiting-list control condition. They will complete survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention.

NCT ID: NCT04498975 Completed - Mental Health Issue Clinical Trials

Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients

Start date: June 1, 2018
Phase:
Study type: Observational

Hopelessness is associated with 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Compounding this issue is often the symptom of hopelessness. The links among hopelessness, PA and mortality and morbidity for patients with IHD remain largely unknown, especially in rural and minority IHD patients. The purpose of this study is to delineate differences in hopelessness between urban and rural patients with IHD, as well as between racial minority, including Hispanic and Native American, and White patients with IHD. Potential mediation of urbanicity and race/ethnicity by social connectedness, a key variable in rural settings, will also be examined. A 6-month longitudinal study will be conducted at Sanford Heart Hospital and Avera Health in Sioux Falls, South Dakota. Hopelessness will be measured using the State-Trait Hopelessness Scale. The results of this study have potential to transform nursing practice by providing a better understanding of hopelessness in IHD patients and informing future exercise rehabilitation studies and interventions in rural and minority populations.

NCT ID: NCT04495543 Completed - Depression Clinical Trials

Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'

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

Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. The results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.

NCT ID: NCT04494594 Completed - Mental Health Issue Clinical Trials

Drinks:Ration - Combat Stress Randomized Controlled Trial

Drinks:Ration
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. The main objective of this participant blinded (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting. Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app which includes interactive features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides Government guidance on alcohol consumption. The trial will be conducted in a veteran population who have sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term benefits of the intervention and reported as a secondary outcome. The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022.