Efficacy, Safety, and Tolerability of a Single Administration of COMP360 in Participants With TRD...
Treatment Resistant DepressionEfficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients...
DepressionAnxiety1 moreAnxiety and depression are associated with work disability, lower participation rate in cardiac rehabilitation and unfavourable life style changes following a coronary heart disease (CHD) event. The prevalence of clinically significant symptoms of depression and anxiety in CHD patients has been estimated to 30-50%. Furthermore, depression and anxiety are associated with a significant increased risk of subsequent major adverse cardiovascular events and mortality in CHD patients. Psychological interventions for anxiety and depression in CHD patients have demonstrated small and uncertain effects of symptoms, and no effect on cardiovascular outcomes. Therefore, testing the effectiveness of specific psychological interventions that may affect central mechanisms for cardiovascular outcomes, has been requested. The Attention training (ATT) Study is a randomized controlled trial comparing group-attention training to wait-list control in 64 patients who experience significant anxiety and depression after a CHD event. It will also be explored whether reduction in psychological symptoms is correlated with changes in biological markers with a potential link to cardiovascular outcomes.
Treatment for Rehabilitation of Action Cognition in Depression
DepressionThe present research study investigates the effects of a brief dynamic imagery intervention added to a short behavioral activation treatment on the treatment acceptability, feasibility, and primary efficacy for individuals with depression. Behavioral activation treatment is a standard treatment for depression. To enhance behavioral activation treatment acceptance and efficacy, a dynamic imagery intervention was added to augment the motor component of imagery and memories. Two types of treatment were compared: (1) behavioral activation treatment and (2) behavioral activation treatment plus dynamic imagery. The behavioral activation treatment is a short 8-session intervention based on a dynamic imagery procedure for enhancing the recruitment of motor activation in cognitive processing. 110 participants will be randomized into two groups. Half will be randomized to standard behavioral activation treatment and a half to behavioral activation treatment plus imagery treatment. Participants complete the assessment before, during (weekly), and after treatment. Follow-up will be measured at 3 months after the end of the treatment.
Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients...
DepressionSo far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health...
Anxiety Disorders and SymptomsDepressive SymptomsDigital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Depressive DisorderMajorThe purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD
Post-stroke DepressionHealthyIntroduction: Post-stroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life. Antidepressants are the first-line treatment for PSD, but many reported side effects remain. Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD. This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression. It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms, neuro-patho-physiological behaviors, quality of life and central response in PSD. Methods: In this randomized, controlled, assessors-blinded trial, sixty-four patients with PSD will be randomly allocated into the experiment group (n=32) or control group(n=32) . The experiment group will receive electro-acupuncture and MRI-navigated rTMS, and the control group will receive MRI-navigated rTMS treatment, in 12-20 sessions over 4 weeks. In addition, ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention. The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items (HAMD-24) scores at week 4. The primary analysis of central mechanism mainly involves cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity based on fMRI at 0-wk and 4-wk. Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential test(MEP), National Institutes of Health Stroke Scale(NIHSS), EuroQol Five Dimensions Questionnaire(EQ-5D) Scale, Modified Barthel Index(MBI) Scale and Short Form-Health Scale of Traditional Chinese Medicine(SF-HSTCM). Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation (cost-effectiveness analysis) to assess acceptability and economic practicality of the treatment in study. Outcomes are assessed at baseline and post intervention. Discussion: Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD, and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD.
Multi-factor Model Constraction for Early Warning and Diagnosis of MDD
Major Depressive DisorderBipolar Disorder1 moreCurrent research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to Major Depressive Disorder(MDD). As reported, physical exercise, Ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. In addition, imaging studies have found changes in the structure and functional connectivity of the brain. Therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder
Clinical Investigation of Wysa
Mental Health IssueAnxiety1 moreMental health concerns are a large burden for individuals, healthcare systems, and the economy. Over a million people are referred to UK mental health services each year, but more than half only receive one session of workbook-based support. Many others have to wait over 12 weeks for assessment and treatment. Wysa is a digital health app with over 3 million users that uses an artificial intelligence (AI) chatbot and a series of self-care exercises to provide mental health support and to help people develop strategies to manage their mental health and improve their resilience. This project aims to examine the impact of using Wysa on patients' symptoms of anxiety and depression during the referral process for standard UK mental health services. Patients will be given access to Wysa at the point of referral to the Improving Access to Psychological Therapies (IAPT) programme and can begin to explore the self-support tools, while they are on the waitlist for assessment and treatment. The investigators will gather a group of patients and members of the public to contribute to the recruitment of patients for the study, the methods we use to evaluate Wysa, and to provide insights on how best to share the results of our study with the general public. The investigators will use the standard IAPT measures of anxiety and depression to look at the effect of using Wysa patients' mental well-being. These questionnaires will be provided through the app and the results will be compared with a waitlist control group. The investigators will examine whether Wysa can identify people who are experiencing severe mental health difficulties so that they can be provided with additional support. Users' levels of engagement with Wysa will be assessed and some participants will be randomly selected to do an interview so the investigators can get a better understanding of what people liked and disliked about using the app and why. Finally, the investigators will be evaluating the cost-effectiveness of Wysa compared with usual care. The investigators expect that the study will show that Wysa helps reduce symptoms of anxiety and depression in people who are on the waiting list for IAPT. If the study shows this positive impact, this will provide evidence to support the use of Wysa to improve the accessibility of mental health support in clinical pathways. The investigators will be publishing the results of our study in academic journals as well as in more generally accessible platforms.
Effectiveness of Individual and Multimedia Versions of Super Skills for Life in Children
Depressive DisorderDepressive Symptoms4 moreSuper Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies. The aim of the study is to investigate the comparative effectiveness of SSL in its traditional and multimedia version on internalizing and externalizing symptoms in Spanish children between 8 and 12 years of age.