Generalized Anxiety Disorder

Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and obsessive-compulsive disorder, which is why researchers describe it as a transdiagnostic feature. A type of therapy called Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has been shown to reduce anxiety in previous trials. What remains to be known is how uncertainty changes when targeted directly, and whether the same mechanism applies across diagnoses. IU has mostly been measured using questionnaires, which indicate whether people find uncertainty difficult, but not what is actually happening when they encounter it. Recent research suggests that IU is not a single trait but a set of differences in how people estimate different kinds of uncertainty. Therefore, in addition to standard questionnaires, computer-based tasks will be used to explore an "uncertainty fingerprint" for each participant, capturing different aspects of uncertainty processing in a way that self-report measures cannot. In this study, the investigators are comparing CBT-IU, adapted to work across disorders, against Applied Relaxation. Applied relaxation is a well-established therapy that teaches people to notice and release physical tension but does not focus on uncertainty. Adults with high IU and anxiety symptoms (regardless of formal diagnosis) will be randomly allocated to one of the two 12-session group therapies. The investigators will measure anxiety and IU using standard questionnaires as the primary outcomes. Additionally, cognitive tasks will be used to measure the uncertainty fingerprint before therapy, immediately after, and three months later. The aim is to test whether reductions in IU are specific to CBT-IU rather than shared with an equally credible therapy that does not target uncertainty. Going beyond self-reports, the trial will then begin to resolve which specific aspects of uncertainty processing change, so that future treatments can be more precisely targeted and better matched to each person.

The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).

The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which emotional regulation processes and common factor of the intervention itself are involved in the therapeutic improvement. The investigators will compare the interventions of four groups: ultra-brief group treatment (1), brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group. The main questions the study aims to answer are: * Will the brief and ultra-brief treatment formats works better than the relaxation-based control group? * Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar? * Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance? * Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

The purpose of this study is to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

This open-label, single-group, non-randomized interventional study will evaluate longitudinal changes in anxiety symptoms, sleep quality, psychological well-being, treatment adherence, tolerability, and safety in adults with clinician-confirmed generalized anxiety disorder. Participants will receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at a protocol dose of 0.5 mL approximately every 12 hours for 8 weeks. Follow-up will continue through Week 12. The study has no placebo or concurrent comparator group. The primary outcome is change in the Generalized Anxiety Disorder 7-item scale (GAD-7) total score from baseline to Week 8. Findings will be descriptive and hypothesis-generating; the design cannot establish that any observed change was caused by the product.

A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.

This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Participants will be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC). Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. The primary objective is to compare changes in anxiety symptom severity, measured using the Hamilton Anxiety Rating Scale (HAM-A), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, quality of life, sleep quality, cognitive function, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.

This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of the study is to explore the lived experiences of the students concerned in order to identify what they perceive as the various aspects of student precarity (housing, transport, isolation, financial difficulties, etc.) and the links they perceive between these and their psychological distress. This study will deepen our understanding of these factors by exploring students' lived experiences, and will bring to light elements not identified by quantitative studies.

The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom. Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health. The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.

The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

This is a single dose study to investigate the efficacy, safety, tolerability and the PK, of SYT-510 in participants who meet diagnostic criteria of GAD. This study represents an evaluation of the effects of SYT-510 in participants meeting DSM-5 GAD diagnostic criteria. As a single dose study, it is designed to evaluate the efficacy of SYT-510 on neurobiological and behavioral markers associated with anxiety and will inform the design of future clinical trials in anxiety disorders. By integrating efficacy / PD, safety, tolerability, and PK measures within the same study framework, the study enables the translational value of the program, ensuring a more comprehensive understanding of SYT-510 effects in patients with generalized anxiety disorders. The plan is to evaluate a single dose of SYT-510 as compared with its matching placebo in a two-way crossover design, separated by a washout period of 7 to 14 days.

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services. Our study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback. The study hypotheses include: * Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF * Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF * PFC activation will positively correlate with CR ability

TRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.

Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients. This randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries. The main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care. This will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.