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Anxiety Disorders clinical trials

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NCT ID: NCT06296030 Withdrawn - Anxiety Clinical Trials

Culturally Tailored ACT for Black Trauma

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated. Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed: Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants. Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks. The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.

NCT ID: NCT06110728 Withdrawn - Depression Clinical Trials

Augmentation of Standard Psychotherapy With a Habit Change App

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to document the efficacy of using a habit change application (app) as an adjunct to standard psychotherapy among individuals with diabetes receiving mental health treatment for depression, anxiety, or substance use disorders. The main questions it aims to answer are: Question 1: When behavioral health treatment is augmented with a habit change app for between visit care, does the use of this tool improve mental and behavioral health outcomes? Question 2: Are there certain populations who benefit more from using a habit change app? Question 3: Does use of a habit change app impact healthcare utilization and costs? Exploratory Research Question: Does use of a habit change app impact physical health outcomes, including A1c levels, blood pressure, and weight? Participants selected to receive the habit change app will be asked to track goals that they set for themselves in adjunct to their current behavioral health treatment; those selected for treatment as usual will have no additional steps to take. Researchers will compare the groups to see if there are different outcomes in symptom reports and healthcare utilization.

NCT ID: NCT05670990 Withdrawn - Depression Clinical Trials

Equine Assisted Services in Children and Adolescents With Mental Illness

EASiCAM
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Due to an increasing amount of children and adolescents are suffering from mental illnesses i Sweden. Early preventive psychological interventions are important to avoid a long-time use of medicines. Animal assisted therapy and especially equine assisted services (EAS) has shown to be a good complementary method to decrease anxiety and/or depression in children and adolescents. The main aim is to study the effect of a specific EAS program regarding symptoms of mental illness and in long-term follow-up of future healthcare consumption. We will conduct interviews with both participants and their parents besides the questionnaires at follow-ups (12 weeks, and 1 year) The intervention will be EAS at a farm following a detailed program, the staff at the farm are specially trained with a certification to practice EAS. Each session will last for about 60 minutes, once a week. Participants will get information of the study by the child and youth psychiatry in the region of Skane, and from student´s health team at elementary schools. Those who want ti participate will contact the study coordinator for full information and informed consent. The EAS model has been used in treatment of adult with mental illness for many years, and the result are very positive. This project provides an opportunity to evaluate the effect of EAS to promote health and prevent severe manifest mental illness among children and adolescents. There are no previous studies of the long-term effect of EAS regarding health consumption.

NCT ID: NCT05429788 Withdrawn - Clinical trials for Social Anxiety Disorder

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

Start date: May 18, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of RLS103 (cannabidiol [CBD] inhaled dry powder) to relieve the anxiety induced by a public speaking challenge in adults with social anxiety disorder (SAD). Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects will enter a screening phase lasting up to 3 weeks and including history, physical examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will undergo a public speaking test after screening tests are performed and eligibility is confirmed. One week after the completion of the public speaking test, subjects will come back for a follow-up visit that will involve a repeat of the safety and psychiatric assessments conducted during screening.

NCT ID: NCT05380115 Withdrawn - Clinical trials for Generalized Anxiety Disorder

Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

Start date: July 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to assess the acceptability and feasibility of the implementation strategy and fidelity of cognitive-behavioral therapy (CBT) for older adults with Generalized Anxiety Disorder.

NCT ID: NCT05344625 Withdrawn - Anxiety Disorders Clinical Trials

Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress

KAPTIVATED
Start date: October 31, 2023
Phase: Early Phase 1
Study type: Interventional

The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress.

NCT ID: NCT05194449 Withdrawn - Dental Anxiety Clinical Trials

Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Dental pain and anxiety are usually managed by local anesthetics and sedatives, but patient anxiety and fear of pain remain common and adversely affect oral health behavior and outcomes. The long-term goal is to provide a validated behavioral alternative/adjunct for managing dental anxiety and pain through a commercial Comfort Talk® (Cft) app. Such an application should benefit the patients undergoing the >300 million dental procedures per year in the US alone. In Phase I (Clinical Trials Identifier NCT03328208), the investigators designed such an app based on short Comfort Talk® scripts and snippets that, when spoken live by trained personnel in our prior large-scale clinical trials, reduced pain, anxiety, and drug use during invasive procedures, and when used practice-wide, improved patient attendance, throughput, and economics. In Phase I, the Cft app significantly reduced pain and anxiety in the dental waiting room. In Phase II, the investigators propose to further assess its impact. We hypothesize that: - The Cft app reduces pain and anxiety in the waiting room - The Cft app improves the patient experience and cooperation during dental treatment - The Cft app improves operations and economics of dental practices - Heart rate tracings are helpful in identifying outcome-critical app elements 150 patients scheduled for root canals or dental implants will receive in randomized sequence the Cft app or a placebo white noise app in the dentistry waiting room of Cambridge Health Alliance. Anxiety and pain will be measured subjectively on validated scales (0-no anxiety/no pain at all; 10-worst anxiety/pain possible) before listening and throughout the visit. Heart rate (HR) and ECG will be continuously recorded to assess adverse events and, in the absence of a validated biomarker for pain and anxiety, serve as an exploratory physiologic indicator of distress. Usage patterns of the Cft and the placebo apps will be established electronically through time-stamped background capture, de-identified, and uploaded to a database along with the corresponding HR recordings and overlayed with the patient's subjective ratings and procedure steps to identify outcome-critical elements of the app. We will record chair-time, staff-time, use of anesthetics and sedatives, if applicable, and patient and staff satisfaction, supplemented by bulk data acquired from other practices that use a co-branded version of the app, to determine the economic impact of the Cft app.

NCT ID: NCT04989972 Withdrawn - Clinical trials for Anxiety and Depression

Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults

Start date: September 15, 2022
Phase: Phase 2
Study type: Interventional

To investigate the efficacy of a 16 week treatment with PSIL428 patient reported anxiety levels in otherwise healthy individuals suffering from depression and or anxiety symptoms.

NCT ID: NCT04965272 Withdrawn - Clinical trials for Generalized Anxiety Disorder

A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone

CAR aGAD Ph 2
Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

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 adverse events and the change in disease activity with cariprazine when added to ADTs compared with placebo in adult participants with GAD who have had an inadequate response to 1 or more prior ADTs alone. Cariprazine is an approved drug being developed for the treatment of GAD. The participants are placed into 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 1072 participants age 18-65 with GAD and an inadequate response to ADT alone will be enrolled in the study in the United States. After a 2-week screening period, participants will receive daily oral capsules of cariprazine of varying doses or placebo for 6 weeks, followed by a 4-week safety follow-up period for a total study duration of 10 weeks. 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.

NCT ID: NCT04839718 Withdrawn - Depression Clinical Trials

Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program

ADAPT
Start date: April 1, 2019
Phase:
Study type: Observational

Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.