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NCT ID: NCT03140124 Terminated - Anxiety Disorders Clinical Trials

Enhancing Therapy Process With Movement Strategies

Start date: November 3, 2015
Phase: N/A
Study type: Interventional

Several studies have noted the benefits of exercise programs in improving both mood and anxiety symptoms. Additionally, single bouts of exercise have been shown to improve mood and anxiety. Business applications report ancillary benefits of exercise as well. For example, individuals spontaneously report better ability to approach stimuli and cope with emotional experiences if doing it while exercising. The current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions. In this study, patient participants will complete a therapy session while using an exercise machine and a separate therapy session while using a worry stone (control). Both patient participants and therapist participants will make ratings of a variety of items, including ability to discuss emotional topics and comfort in experiencing emotions. Investigators hypothesize that patients will report better ability to discuss emotional topics and more comfort in experiencing emotions following the exercise condition as opposed to the worry stone condition. Investigators also hypothesize that therapist ratings will similarly indicate that patients were better able to discuss emotional topics and experience emotional content during exercise sessions.

NCT ID: NCT03135990 Terminated - Clinical trials for Social Anxiety Disorder

Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth

Start date: August 14, 2018
Phase: N/A
Study type: Interventional

Anxiety disorders are the most common mental health diagnosis in the US and are associated with avoidance that causes functional impairments and decreases quality of life. Social anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset being in adolescence. The frontline treatment for social anxiety disorder is cognitive behavioral therapy with exposure. However, a significant number of adolescent patients do not get better after completing cognitive behavioral therapy or experience relapse. This could be explained by findings in both mice and humans suggesting that cue-based extinction learning occurs less readily in adolescents than in children and adults. Studies using mouse-models have overcome this age disparity by enhancing contextual cues when fear extinction learning takes place. Providing realistic learning contexts for exposure could be the key to enhancing treatment effects in adolescents. This is often challenging for a variety of reasons, including difficulty realistically mimicking anxiety-provoking social situations due to limited resources, clinician training, time, or motivation. Virtual reality environments could provide contextual exposures for social anxiety. This pilot study will test the feasibility of integrating virtual reality technology in exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and assessing feasibility of virtual reality technology with this population. We will also pilot a fear conditioning and extinction learning paradigm to explore the relationship between extinction learning and efficacy of virtual reality exposure therapy, using physiological assessment indicators to mark changes in fear response. These markers will also be used prior to the initiation of the therapy to assess the degree to which virtual reality environments invoke a true fear response, comparing the 12 participants with social phobia to 12 age matched, non-anxious control participants. The aims of this study are threefold: to assess feasibility of using virtual reality in treatment of social anxiety in youth, to examine whether virtual reality invokes arousal similar to anxiety and test the physiological assessment protocol, and to evaluate whether exposure using virtual reality environments reduces symptoms of social anxiety and related functional impairment.

NCT ID: NCT03116165 Terminated - Clinical trials for Post Traumatic Stress Disorder

Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder

Start date: April 18, 2017
Phase: N/A
Study type: Interventional

This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.

NCT ID: NCT03095170 Terminated - Clinical trials for Mild Cognitive Impairment

Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

PEACEOFMND
Start date: March 23, 2017
Phase: N/A
Study type: Interventional

Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.

NCT ID: NCT03093025 Terminated - Clinical trials for Major Depressive Disorder

A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder

Start date: July 3, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).

NCT ID: NCT03078270 Terminated - Anxiety Clinical Trials

A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

The goal of this study is to see whether Botox is an effective treatment for social anxiety disorder (SAD). Participants will complete two short surveys on depression and anxiety symptoms, receive a one-time injection of Botox, and complete the depression and anxiety survey 4 weeks after injection and again at 8 weeks after injection.

NCT ID: NCT03068676 Terminated - Depression Clinical Trials

Internet-delivered Treatments for Depression and Anxiety in Primary Care (SUMMA)

Start date: February 8, 2017
Phase: N/A
Study type: Interventional

The current study is an open feasibility trial with the aim of providing a description of the factors associated with the implementation of an iCBT platform into an existing treatment framework in a primary care setting. The trial will examine the factors surrounding implementation, such as the experience of primary care practitioners and the online supporters, the recruitment process, and attitudes towards the overall implementation of the interventions. Patients presenting to the primary care setting will be screened using standard depression and anxiety measures, and where appropriate, will be referred to an iCBT intervention for either depression or anxiety, with support from trained staff. Analyses will be conducted on outcome measures to examine changes in symptom severity as patients progress through the intervention. Patient satisfaction data will also be collected to establish patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at Ohio Family Practice Center]

NCT ID: NCT03047577 Terminated - Clinical trials for Alcohol Use Disorder

Brief Intervention for ICU Patients With Alcohol Use Disorders

ICU-BI
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

Patients non-electively admitted to intensive care units (ICUs) will be screened for eligibility. The investigators will include adult patients with risk level alcohol use, defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained from the patient in the end or shortly after the ICU treatment, when they have regained sufficient cognitive function. 600 patients will be randomized to receive either routine treatment or a brief intervention (BI). The BI includes a 20 minute discussion with pre-educated study personnel, option to discussion with a social worker and written material. Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an interview by a study team member blinded for the intervention arm at 6 months 2) A letter of a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded. An interim analysis by an external reviewer will be performed after the primary outcome has been recorded for 200 patients,

NCT ID: NCT02998606 Terminated - Esophagus Disorder Clinical Trials

Movantik for Opioid-Related Esophageal Disorders

Start date: January 2017
Phase: Phase 2
Study type: Interventional

To date, few studies have assessed the effect of opioids on esophageal motility, mostly assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a large retrospective study assessing the effect of opioids on esophageal motility found that esophageal motor dysfunction are common in chronic opioid users whether studied on opioids and off opioids. In addition, current opioid users also had significantly higher integrated relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli 2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose, MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is associated with preservation of centrally mediated analgesia. This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient population. The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced esophageal motility disorders

NCT ID: NCT02994433 Terminated - Clinical trials for Depressive Disorder, Major

NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits

Start date: January 27, 2017
Phase: Phase 1
Study type: Interventional

Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This application proposes to take the next important step in understanding how nitrous oxide exerts its effects in the human brain by using state-of-the-art brain neuroimaging (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy volunteers and comparing the results to a group of TRMD patients. This study involves exposing 20 non-depressed healthy participants and 20 TRMD participants to nitrous oxide and a placebo gas, to compare their brain images before and after each of the inhalation sessions. Sessions will be separated by at least one month to prevent treatment effects from carrying over into the following session. All willing and eligible subjects will undergo up to six functional connectivity MRI scans, and two inhalation sessions. Functional imaging in the brain will allow us to trace the interconnections between various parts of the brain, including those involved with emotion and depression. Other procedures will involve screening materials to ensure safety of the participants before beginning the study (i.e. no MRI scan contraindications) and that subjects meet eligibility criteria to being in the targeted age range, depression/non-depressed state, neurological disorder history, and no medication exclusions.