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56 active trials for Mental Disorder

Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use. Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit. Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health. The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

BarcelonaStart: May 2021
App-based Mental Health Promotion in Young European Adults

The ECoWeB Project aims to develop and disseminate a mobile application (App) to provide engaging and personalized tools and psychological skills to promote emotional wellbeing and prevent mental health problems in adolescents and young adults. The project team involves 8 European nations (the United Kingdom, Germany, Belgium, Spain, Greece, the Czech Republic, Denmark, and Switzerland) working together in order to improve mental health care and access for adolescents and young adults: To use technology as a tool to assess and promote emotional well-being. To deliver empirically supported psychological interventions through a smart phone application to address the needs of adolescents and young adults. To improve mental well-being and prevent mental health problems in European adolescents and young adults. The ECoWeb project will consist of 2 RCT's within a longitudinal prospective cohort called ECoWeB-PROMOTE (indicating PROMOTION of well-being and good mental health) and ECoWeB-PREVENT (indicating PREVENTION of general distress, poor mental health and emotional disorders) respectively. These trials share the same recruitment procedure, interventions, outcomes (including self-report measures of well-being, anxiety, and depression) and design. Both are interested in the promotion of well-being and the prevention of general poor mental health in young people. The key difference is whether the participants are deemed to be at higher or lower risk criteria for poor mental health based on their general emotional competence skills, i.e., for those at low risk, do the interventions further enhance well-being, for those at higher risk, do the interventions prevent the worsening of poor mental health, general stress and distress, as well as enhancing well-being. In all cases the recruitment procedure will be the same, but the inclusion and exclusion criteria are different and the primary outcome measures are different hence they are 2 trials, rather than one, all running within the same cohort.

GhentStart: October 2020
Feasibility and Acceptability of Collaborative Care for People With Musculoskeletal and Mental Problems

This study aims to implement a feasibility Randomised Controlled Trial to support patients with musculoskeletal problems and a co-existing mental condition, which the intervention will be the implementation of a Collaborative Care Model. In England, one in six adults suffers from a mental health condition, such as anxiety or depression. Despite these high numbers, mental health conditions are often unrecognised in physical healthcare settings, including patients with musculoskeletal (MSK) conditions. Patients with both a physical and mental health diagnosis are likely more difficult to treat in comparison to those with just a physical health condition. The Collaborative Care Model offers an alternative way of improving musculoskeletal rehabilitation as it takes into consideration both physical and mental health needs. This model involves physical and mental healthcare professionals working together to better identify and manage people with both conditions. Patients are then further supported by a Case Manager who coordinates access to relevant professionals/services following an assessment of both physical and mental health needs. The investigators propose a feasibility study to assess whether the collaborative care model is beneficial to orthopaedic patients in addressing both physical and mental health needs. Patients over 18 years old, with an MSK condition attending therapy services at the Royal National Orthopaedic Hospital with a moderate to severe anxiety or depression score, may be eligible. Following informed consent, they will be randomly allocated to either treatment as usual or the intervention group (the collaborative care model with input from a Case Manager). All participants will participate for 6 months with a follow-up on months 3 and 6.

Stanmore, UKStart: October 2021
Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities

Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system. Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity. The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). We aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.

Chicago, IllinoisStart: May 2021
Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare

Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy. In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy. Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation. Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online). The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.

CologneStart: March 2017
Drinks:Ration - Combat Stress Randomized Controlled Trial

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.

Leatherhead, SurreyStart: October 2020