Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
AlcoholismGeneralized Anxiety Disorder3 moreThe purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.
Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia
Phobic DisordersAnxiety1 moreThis study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the type of learning that is promoted by exposure therapy, a main component of CBT. This study will test whether DCS can improve the effectiveness of CBT for social anxiety. All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT, participants will be randomly assigned (similar to a coin toss) to receive either DCS or a placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions. The pill is taken only on the 12 therapy days. Prior to receiving treatment, participants will be asked to: participate in interviews to assess diagnosis and how they are doing including mood, degree of nervousness and behavior have a physical examination, a urine test, and an electrocardiogram (EKG) undergo tests involving problem-solving and memory prepare and present a speech to a "virtual audience" using virtual reality goggles undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months. If a participant does not wish to take medication, study clinicians will help him/her locate psychological care in the community. Participants will be asked to complete a follow-up assessment 3 months after their last CBT session.
St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
Anxiety DisordersMental HealthThis study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD). Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
Anxiety DisorderThe purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
Treatment for Anxiety in Children
Obsessive-Compulsive DisorderAnxiety Disorders3 moreThe purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine. Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to behavioral therapies alone. These disorders may respond to fluvoxamine. A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this double-blind phase (neither the child/parents nor the doctor know which treatment is being given), the child will have the option of continuing treatment during a 4-month open-label extension period (both the child/parents and the doctor know which the child is receiving). A child may be eligible for this study if he/she: Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).
Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems
Anxiety DisordersSocial Anxiety Disorder4 moreTo investigate the efficacy and mechanisms of change of an Internet-delivered transdiagnostic REBT intervention for adolescents with internalizing problems.
CBT With VR Based Exposure for Social Anxiety Disorder
Social AnxietySocial Anxiety Disorder (SAD) is classified as a phobic (anxious) disorder in which the patient experiences anxiety in social interactions, during which he or she might be judged or socially evaluated by others. SAD has an estimated lifetime prevalence of 3-13%, but remains under-treated. The recommended psychological treatment for SAD is is the exposure technique imbedded in Cognitive Behavioral Therapy (CBT). Traditionally exposure has taken place either in vivo or through imaginary exposure. In vivo has shown to be most effective, but it is costly and time-consuming and situational elements, such as the reaction of others, are difficult to control. Recently, researchers and clinicians have started to use Virtual Reality (VR) to overcome such difficulties. Compared to traditional methods VR-based Exposure has several advantages mainly based on increased control. Meta-analyzes have found superior effect of CBT with VR-based Exposure compared to imaginary exposure, and similar effects when compared to in vivo exposure, with a recent study finding superior effect of VR-based Exposure compared to in vivo. The current evidence thus supports the clinical efficacy of CBT with VR-based Exposure. However, the meta-analyzes include a total of only six randomized controlled trials (RCTs) and only four of these compare CBT with VR-based Exposure to both an in vivo and a control group. The aims of the current study are to develop a complete program of CBT with VR exposure based on 360° videos for adults suffering from SAD, and to evaluate the treatment effect on SAD symptoms. The study is designed as a three arm RCT comparing 1) a group receiving CBT with VR-based Exposure, 2) a group receiving CBT with in vivo exposure and 3) a group receiving VR relaxation. CBT with VR-based Exposure, will include 360° videos with three different scenarios In Vivo Exposure Therapy consists of role-playing and guided exposure either inside or outside the therapist's office. VR Relaxation Therapy consists of a VR scenario of swimming with dolphins. Treatment will last 10 weeks and there will be a 6 months follow-up. . It is hypothesized that CBT with VR-based Exposure will reduce symptoms of SAD CBT with VR-based Exposure will be more effective than both CBT with in vivo exposure and VR relaxation therapy at the end of treatment An effect on symptom reduction will sustain at the 6 months follow-up
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Social Anxiety DisorderThis Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge. Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.
VR Mind and VR Mind+ Intervention
Social PhobiaThe aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic...
DepressionUnipolar2 moreTransdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have been proven just as effective as traditional diagnosis specific CBT manuals. The investigators have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) to make it applicable as group therapy in Danish Mental Health Service and a naturalistic trial of this manual has shown promising results. As the use of one manual instead of several diagnosis specific manuals in regional clinics could simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT with diagnosis specific group CBT. Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each intervention arm, recruited from three Danish regional Mental Health Service Clinics. 31st July 2018 suppl: Inclusion number expanded to 170 in each arm due to unexpected large drop-out.