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NCT07478744
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.
NCT06934525
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., psychologist, social worker). 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.
NCT07565714
The aim of the study is to examine the effect of imagery rescripting (ImRs) in the context of utilizing large language models (LLMs). Intervention will involve the prior presentation of the most aversive fragment of the memory, the so-called 'hotspot.' This intervention will allow for the replication of the effect described by Dibbets and Arntz (2016), according to which the prior activation of the most emotional element of a memory enhances the effectiveness of ImRs. The study is also significant due to another ongoing study in which a substantial number of participants have already been examined; however, due to the exhaustion of funds, it was not possible to utilize the remainder of the recruited sample. Investigating an additional condition will allow for a more complete utilization of the available participant pool and significantly increase the project's scientific value by comparing the traditional ImRs mechanism with its AI-generated version.
NCT03585010
This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).
NCT07538427
The goal of this clinical trial is to learn whether a music-based intervention can improve mental and physical health and strengthen coping skills among adults living in residential care settings in northern Arizona. The main questions it aims to answer are: Does participation in the music-based intervention reduce stress, anxiety, depression, and pain?, and Does participation increase the use of music as a coping strategy and improve overall well-being? Researchers will compare participants' pre-intervention and post-intervention responses to determine whether the music classes are associated with improvements in health and coping outcomes. Participants will: Attend a 6-week music class held once per week for one hour; participate in active music activities such as drumming and rhythm exercises; complete a brief survey before and after the intervention. Some participants are also invited to complete a short interview about their experiences.
NCT05249543
The primary aim of the pilot study is to investigate the feasibility of conducting a randomized controlled trial (RCT) comparing the effects of transdiagnostic and diagnosis-specific cognitive-behavioral therapy (CBT) for patients with anxiety disorders in routine psychiatric outpatient care in Stockholm, Sweden. It is hypothesized that an RCT is feasible in terms of recruitment, retention, therapist competence and adherence to treatments, and that the treatments are well received by participants.
NCT06124014
The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.
NCT06804525
The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders. To mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study. In a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation. This experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.
NCT05967468
Anxiety and obsessive-compulsive disorders are among the most common in children. Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one method to increase access to care. The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.
NCT06942429
The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question: • Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response? Researchers will compare two care models: * Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed. * Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary. Participants will: * Be randomly assigned to one of the two care models. * Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint. * Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment. * Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.
NCT07430800
Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT sessions, reducing its effectiveness. Socially assistive robots (SARs) help promote adherence to home-based practice in the context of elder care, social skill learning, and physical therapy, but it is unknown how SARs can enhance CBT. The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety. To meet the goals of the proposed work, these studies will determine how SAR personalization based on implicit and explicit feedback can help promote greater CBT compliance and anxiety reduction outcomes for students.
NCT07429578
This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.
NCT06661460
The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial. The primary objective of the study is: 1\. To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS). Secondary objectives of the study are: 1. To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment. 2. To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention. 3. To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome. 4. To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use. Participants will: * Undergo ICBT treatment for anxiety disorders during 12 weeks * Complete questionnaires at multiple time points throughout the study * Participate in follow-ups post-treatment and 3 months post-treatment * A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use
NCT05467683
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?"
NCT07391020
The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.
NCT03113175
The aim of the study Collabri Flex is to: * Develop a Danish model for collaborative care for patients with anxiety in general practice, based on past experience gained in the Collabri Project. * Examine the impact of this model compared with liaison-consultation for people with anxiety in a randomized controlled design from selected endpoints.
NCT02872051
The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark
NCT07382323
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.
NCT06846320
Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT07330648
A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.