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75 active trials for Depression, Anxiety

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

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:

Start: April 2021

Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications

The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.

Start: August 2020

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

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.

Start: August 2020

Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.

Start: November 2019

Mental Health and Academic Performance in COVID-19

This study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. Additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their perception of academic performance.

Start: April 2020

Pain in Patients With Crohn Disease (PAINCD)

Abdominal pain is a common symptom in patients with Crohn disease (CD). Pain is multifactorial, may result from inflammation but persists in many patients during remission. The aim of our study is to determine the epidemiology of pain in CD patients and define the characteristics of pain : localisation, temporal and sensorial characteristics, neuropathic component, impact on quality of life and mood.

Start: October 2020

Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders

The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams. Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge. Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created. These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers. In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.

Start: September 2020

PCBH With the Addition of Self-help CBT

The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients. Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated. This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines. PCBH has the potential to increase the quality of care for patients with mental health problems. This study is the first to step towards answering the question if the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implemented treatments can increase them.

Start: February 2019

Quality Assurance of Cognitive-behavioral Therapy

The study examines associations between competence in cognitive-behavioral therapy (CBT) and adherence to evidence-based generic CBT in therapists and treatment outcome in patients with depression or an anxiety disorder in psychiatric outpatient care.

Start: August 2018

Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19

Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus. Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found. The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation). The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.

Start: March 2020

Self-help Lifestyle Medicine for Depression and Anxiety

This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.

Start: February 2020

T.E.A.M. Feasibility and Efficacy Study 2.0

T.E.A.M. psychotherapy was developed by one of the founders of cognitive therapy, David Burns and builds on traditional CBT with an emphasis on T = Testing, E = Empathy, A = Agenda Setting (assessing and building motivation) and M = Methods (including cognitive and behavioral methods). Because TEAM therapy is a data-driven therapy, its delivery hinges on the use of symptom measures and measures of the therapeutic alliance at every session with every patient. These measures are now available for collection thru computerized forms, making their collection and review considerably more accessible and efficient for the patient and therapist. The following hypotheses will be tested: TEAM psychotherapy using computerized measurement collection is safe and feasible. TEAM psychotherapy using computerized measurement collection shows evidence of efficacy by exploratory non inferiority testing compared to benchmark studies with similar psychotherapeutic modalities Evidence for efficacy is strong enough to justify pursuit of an experimental randomized controlled clinical trial of TEAM therapy for major depressive disorder versus treatment as usual.

Start: April 2019

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.

Start: November 2017

School Health Implementation Network: Eastern Mediterranean

Background An estimated 10-20% of children globally are affected by a mental health problem. Child mental health has been identified as a priority issue by the World Health Organization's Eastern Mediterranean Regional Office (WHO EMRO). Following consultations with international and regional experts and stakeholders, WHO EMRO developed an evidence-based School Mental Health Program (SMHP), endorsed by WHO EMRO member countries, including Pakistan. The federal and provincial health departments in Pakistan made recommendations for a phased implementation of the SMHP in a pilot district. In the formative phase of this program, a number of implementation challenges were identified by the stakeholders. Broadly, these included the need to operationalize and adapt the existing components of the intervention to the local context and to develop sustainable mechanisms for delivery of quality training and supervision. Informed by the results of a formative phase investigations, the SHINE scale-up research team adapted the SMHP (henceforth called Conventional SMHP or cSMHP) to address these implementation challenges. The enhanced version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to cSMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's wellbeing, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings. Objectives The primary objective of the study is to evaluate the effectiveness of eSMHP in reducing socio-emotional difficulties in school-going children, aged 8-13, compared to cSMHP in Gujar Khan, a rural sub-district of Rawalpindi, Pakistan. The secondary objectives are to compare the cost-effectiveness, acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability of scaled-up implementation of eSMHP and cSMHP. It is hypothesized that eSMHP will prove to be both more effective and more scalable than cSMHP. Study population The research is embedded within the phased district level implementation of the cSMHP in Rawalpindi, Pakistan. The study population will consist of children of both genders, aged 8-13 (n=960) with socio-emotional difficulties, studying in rural public schools of sub-district Gujar Khan in Rawalpindi. Design The proposed study design is a cluster randomized controlled trial (cRCT), embedded within the conventional implementation of the SMHP. Following relevant ethics committees and regulatory approvals, 80 eligible schools, stratified by gender, will be randomized into intervention and control arms with a 1:1 allocation ratio. Following informed consent from the parent/ primary caregiver, children will be screened for socio-emotional difficulties using Strengths and Difficulties Questionnaire (SDQ). 960 children scoring > 12 on the teacher-rated SDQ total difficulty scores and > 14 on the parent-rated SDQ total difficulty scores will be recruited and equally randomized into intervention and control arms (480 in each arm). Teachers in the intervention arm will receive training in eSMHP, whereas teachers in the active control will be trained in cSMHP. Trained teachers will deliver the program to children in their respective arms. Outcome measures Primary Outcome: The primary outcome is reduction in socio-emotional total difficulties scores, measured with the parent-rated SDQ, 9 months after commencing intervention delivery. Secondary Outcomes: Implementation data on acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability outcomes will be collected from children, parents/primary caregivers, head teachers and teachers. In addition, data will be collected on self-reported Psychological Outcome Profiles (PSYCHLOPS)-KIDS to measure progress on psycho-social problems and wellbeing; annual academic performance; classroom absenteeism, stigmatizing experiences and parent-teacher interaction. Data on teachers' sense of efficacy and subjective well-being, and on the schools' psychosocial environment profile will be collected. All secondary outcome data will be collected at baseline and 9 months after commencing intervention delivery. Outcomes will be analyzed on an intention to treat basis. The role of various factors as potential mediators and moderators eSMHP effectiveness will be explored. Cost-effectiveness evaluation of SMHP shall be evaluated in terms of costs associated with implementation of eSMHP compared with cSMHP.

Start: October 2019

Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents

The current study will evaluate and compare the effectiveness of cognitive-behavioral and psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with depression and/or anxiety disorder will be randomly assigned to a treatment or a control condition. The intervention´s short-term effectiveness and sustainability as well as cost-effectiveness will be examined over a 5 year period for each participant.

Start: December 2017