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Anxiety Disorder clinical trials

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NCT ID: NCT02153944 Completed - Anxiety Disorder Clinical Trials

Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety

Start date: June 16, 2014
Phase: Phase 4
Study type: Interventional

Objective: The overall aim of this protocol is to examine the effect of pharmacological manipulations of affective and cognitive processes on anxiety and task performance. Ultimately, the goal is 1) to provide insight into the relative influence of cognitive and affective states on anxiety, 2) generate theoretical models that can be applied to a better understanding of the interaction between cognition and emotion, 3) develop a better screening approach to candidate anxiolytics, and 4) help formulate novel therapeutic interventions for clinical anxiety. Excessive or inappropriately sustained anxiety and fear lead to the most common group of psychiatric disorders. A number of theoretical models have been proposed to understand the mechanisms engaged in these maladaptive behaviors. Most recent emphasis has focused on the synergistic contribution of cognitive and emotional processes. Our laboratory has been instrumental in delineating aspects of behavioral and neural processes that are associated with fear and anxiety, using psychophysiological and neuroimaging measures of fear and anxiety. Evidence shows that levels of anxiety modulate cognitive performance, such as working memory or perceptual discrimination, and that, conversely, cognitive engagement influences severity of experimentally induced anxiety. The exact contribution of emotional processes vs. cognitive processes to the experience of anxiety is not clear, similarly to the neural mechanisms underlying these interactions. In this protocol, we propose to manipulate pharmacologically separately cognitive and emotional processes to dissociate their contribution to fear/anxiety, while using state-of-the-art measures of anxiety derived from translational work. Indeed, we already developed integrative experimental models of fear and anxiety via the manipulation of predictable and unpredictable shock, respectively. We already employed successfully these models to measure anxiolytic and anxiogenic effects of various compounds such as alprazolam, citalopram, hydrocortisone, and oxytocin in healthy participants. We propose in a first step (step-1) to start with a simple proof-of-concept study, using two pharmacological compounds in a double-blind randomized parallel design, each preferentially acting respectively on the cognitive (methylphenidate) or affective (propranolol) domain, and using a single cognitive process (working memory). In a second step (step-2), we propose to extend this work to the fMRI to examine the cognitive correlates of the effects seen in the step-1 behavioral study, specifically with methylphenidate. Whereas the comparison among three drugs is planned for the electrophysiology study, we plan to study only the drug that improves cognition in the fMRI. The reason we will focus on methylphenidate in step 2 is that our overall goal is to study the effect of improving cognitive functions on anxiety using neuroimaging. To reach this goal, we plan to use different approaches to boost cognitive functions in the coming years, including psychopharmacology, direct current stimulation, mindfulness. Methylphenidate is our first psychopharmacological study towards this objective. Future work will also expand to other compounds and cognitive processes, as well as vary the strategy to induce anxiety. Presently, anxiety will be induced using the threat of shock, while participants perform the task. We will examine in step-1 whether 1) the reduction of induced-anxiety with propranolol improves cognitive performance, and 2) the facilitation of cognitive performance with methylphenidate reduces induced-anxiety. In step-2, we will identify the neural mechanisms underlying the effects of methylphenidate, the drug having beneficial effects on cognitive function. Study population: Medically and psychiatrically healthy adult males and females, aged 18 to 50 years. Design: The study is a double-blind design. For step-1, three groups of healthy participants will come for one experimental session. During this session, they will be asked to perform a working memory task under the threat of shock, i.e., while anticipating unpleasant electric shocks. Each group will receive one drug challenge, either placebo, propranolol (40 g) or methylphenidate (20 mg). For step-2, the study tasks will be conducted in a 3T fMRI scanner. In this step, only methylphenidate and placebo will be compared. Two groups will come for one experimental session, one will receive placebo and the other one will receive methylphenidate (20 mg). In a follow-up study for the step-2 fMRI the two groups will come for one experimental fMRI session one will receive methylphenidate (60 mg). Outcome measures: In step-1, the primary outcome measures are the startle reflex and performance on the working memory task. In step-2, the primary outcome measures are the startle reflex and the cerebral fMRI blood-oxygen-level ...

NCT ID: NCT02145429 Completed - Depression Clinical Trials

Preventing Depression in Late Life: A Model for Low and Middle Income Countries

Start date: September 2013
Phase: N/A
Study type: Interventional

This study is being conducted in GOA India. The study addresses specific issues of depression prevention in older adults living in low- and middle income countries (LMICs), by developing risk-reduction strategies through the use of lay health counselors. We will be training Lay Health Counselors (LHC's) to deliver simple behaviorally oriented interventions, designed to enhance the ability to relax, to improve active coping via better problem solving, and to increase protective factors such as good quality sleep. Lay Health Counselors are inhabitants of Goa. The aim of phase 1 is to create a depression and anxiety prevention intervention for use by lay health counselors. We will test the feasibility and acceptability of Problem Solving Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The products of phase 1 will be a prevention and counseling manual to standardize the implementation of the interventions for further testing in a randomized prevention trial (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population. In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing and retaining participants; implement the experimental intervention and enhanced usual care; identify "real world", barriers and develop strategies for addressing them; and assess the fidelity of the interventions.

NCT ID: NCT02119975 Completed - Major Depression Clinical Trials

A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals

Start date: August 2011
Phase: N/A
Study type: Interventional

Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.

NCT ID: NCT02119923 Completed - Major Depression Clinical Trials

Tackling Depression and Anxiety: A Working Memory Intervention

Start date: April 2011
Phase: N/A
Study type: Interventional

Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination. Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks. Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only result in a reduction of anxiety symptoms in the depression group. These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.

NCT ID: NCT02096783 Completed - Cervical Cancer Clinical Trials

Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

Start date: September 2014
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

NCT ID: NCT02084979 Completed - Anxiety Disorder Clinical Trials

A Controlled Trial of Patient Centered Telepsychiatry Interventions

Start date: April 2014
Phase: N/A
Study type: Interventional

This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

NCT ID: NCT01929720 Completed - Depression Clinical Trials

Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors

FOCUS
Start date: August 2011
Phase: N/A
Study type: Interventional

This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.

NCT ID: NCT01926613 Completed - Schizophrenia Clinical Trials

Thinking Skills for Work in Severe Mental Illness

TSW
Start date: April 2006
Phase: N/A
Study type: Interventional

The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.

NCT ID: NCT01778478 Completed - Depression Clinical Trials

A Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults

Start date: January 26, 2013
Phase:
Study type: Observational

Background: - An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Both the child and a parent are asked questions about the child s behaviors and symptoms that might indicate such problems. Researchers want to see if the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two groups of young adults, including healthy volunteers and people with cancer, and their parents will participate in this study. Objectives: - To see if the K-SADS-PL interview used for children and teens can also be used for young adults. - To see whether information provided by parents will affect the rate of mental health problems found. Eligibility: - Individuals aged 18-25 years who have cancer and are participating in research studies at the National Institutes of Health. - Healthy volunteers aged 18-25 years. - A parent of a young adult who is participating in this study. Design: - This study requires one study visit that includes an interview and self-report questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will also be required. - Young adult participants will be given the K-SADS-PL interview and four questionnaires that ask about mood, anxiety, distress, parental contact, and development during childhood. The K-SADS-PL interview will be video recorded or audio recorded. - Parents will also be given the K-SADS-PL interview. This interview can be done in person or by phone, and will also be recorded. - No treatment will be provided as part of this study.

NCT ID: NCT01764789 Completed - Depression Clinical Trials

Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

Start date: October 2010
Phase: N/A
Study type: Interventional

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.