Track topics on Twitter Track topics that are important to you
The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized clinical trial examining the feasibility of completing a larger scale efficacy study of a novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth with anxiety disorders. The primary objective is to establish the feasibility of a blinded randomized controlled trial of ANM for childhood anxiety disorders.
The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized clinical trial examining the feasibility of completing a larger scale efficacy study of a novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth with anxiety disorders. Phase I involves a randomized controlled trial comparing active acoustic neuromodulation to a non-active acoustic stimuli (Placebo or PBO) in youth ages 7-17 years with at least one of the following primary DSM-5 diagnoses: separation anxiety disorder (SAD), social anxiety disorder and generalized anxiety disorder (GAD).
Additionally, this study will include up to ten healthy volunteer participants in order for study staff to be appropriately trained to administer the EEG. Furthermore, three pilot cases will be completed at the start of data collection to ensure effective delivery of all study procedures and maintenance of blind during the acute study phase. Phase II is a 3-month treatment maintenance period for Phase I responders. Phase I non-responders to PBO will be offered active open treatment. Assessments will include those that will likely be used in a larger efficacy trial including parent on child report, and child self report, and blinded independent evaluator ratings of the primary outcomes. In addition, in an effort to assess over all feasibility, monthly recruitment rate, number of consents signed, subjects randomized, rate of adherence to the treatment protocol, safety of the intervention and control conditions, patient and family acceptability of the treatment and assessment protocols will be evaluated. Study Phases Entry Gates: 30 subjects ages 7-17 years will be enrolled, using a multiple gating procedure designed to ensure that subjects enrolled evidence a stable, pervasive anxiety diagnosis at the start of treatment.
- Gate A is a 20-minute semi-scripted telephone screening procedure to elicit preliminary inclusion/exclusion information and to provide additional information to the caller.
- Gate B is a screening assessment that determines "caseness".
After completing informed consent participants and their parents will complete standard questionnaires and will be interviewed to establish that the child meets all inclusion and no exclusion criteria and are medically safe to complete the study (clearance from the pediatrician and pregnancy test for menstruating females). This visit will be videotaped and will last approximately 2.5 hours.
-Gate C is a baseline assessment of anxiety severity and randomization visit and takes approximately 2.5 hours and will be videotaped. All subjects will be recruited and screened and enrolled by investigators at the Weill Cornell Medical College.
Phase I: Phase I is a 6-week randomized (1:1) controlled comparison of ANM and PBO. Subjects will come in for 20-minute treatment sessions approximately every other day for 2 weeks (5 days in 2 weeks). At each study treatment visit the study coordinator will collect a brief interim history of anxiety symptoms and adverse events prior to treatment. Formal outcome assessment by the blind independent evaluator (IE) will be collected at week 6.
Phase II: Phase II is a 17 week treatment maintenance phase (from week 7 to 24). At this stage, ALL PARTICIPANTS will begin active treatment. Active responders from phase 1 will be monitored for the durability of the treatment response. Non-responders to the active treatments will be given a second chance to elicit a response. Non-responders to control treatment will have a full course of the active treatment. Control treatment responders will be given the chance to respond to active treatment. At each study visit the coordinator will collect an interim history and adverse events. Formal outcome assessment by a blind independent evaluator will occur at weeks 12 and 24
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Separation Anxiety Disorder
Acoustic Neuromodulation (ANM)
Weill Cornell Medical College
Weill Medical College of Cornell University
Published on BioPortfolio: 2015-10-13T11:08:22-0400
The purpose of this study is to determine whether a specific family based cognitive behavioral treatment program is effective in the treatment of children with separation anxiety disorder.
The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disor...
The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disor...
The objective of this study is to investigate the feasibility of cervical TEN stimulation (TENS) delivered to the back of the neck to decrease anxiety and sleep issues in young adults with...
The study is an open trial to evaluate a web-based intervention. The intervention focuses on supporting parents to help their children to overcome problems with anxiety. The children who a...
Anxiety disorders are common among children and adolescents; almost one-third of this population has an anxiety disorder. The most common anxiety disorders in this population are specific phobia (19.3...
Due to the co-occurrence of symptoms of anxiety disorders and obsessive-compulsive disorders, and the hypothesis about common etiopathological factors, we performed a research addressing the occurrenc...
Anxiety disorders in childhood might be associated with an increased risk of substance use disorders. Incident substance use-related diagnoses were quantified in the 2 years after youth were newly dia...
We examined the accuracy of the anxiety not otherwise specified (anxiety NOS) diagnosis in 61 patients, using data from older Veterans screened for a large trial of cognitive behavioral therapy for la...
The Contrast Avoidance Model postulates that individuals with generalized anxiety disorder (GAD) fear a sharp spike in negative emotion, and thus, prefer to worry to maintain their negative affect rat...
Anxiety experienced by an individual upon separation from a person or object of particular significance to him.
Anxiety disorder characterized by the persistent and irrational fear, anxiety, or avoidance of social or performance situations.
Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. Some are also effective as anticonvulsants, muscle relaxants, or anesthesia adjuvants. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here.
A self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a diagnostic tool containing modules on multiple mental health disorders including anxiety, alcohol, eating, and somatoform modules. The Patient Health Questionnaire (PHQ-9) is designed specifically for mood/depression scoring each of the 9 DSM-IV criteria based on the mood module from the original PRIME-MD. The Generalized Anxiety Disorder scale (GAD-7) scores 7 common anxiety symptoms.
A personality disorder characterized by a pervasive and excessive need to be taken care of that leads to submissive and clinging behavior and fears of separation, beginning by early adulthood and present in a variety of contexts. (From DSM-IV, 1994)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...