1,576 Clinical Trials for Various Conditions
This study evaluates the feasibility and acceptability of a prototype for NST-SPARK (version 1.5). This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia. NST-SPARK uses a game AR activity to recapitulate the beginning activation and engagement phase of each CT-R session as per standardized practices for this therapeutic modality.
CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity. 1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation. 2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale. 3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices.
To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students.
The purpose of this study is to assess the feasibility of combining IV ketamine, a rapid acting antidepressant, with a course of Mindfulness-Based Cognitive Therapy (MBCT), for the initial and maintenance treatment of depression.
Mindfulness-Based Cognitive Therapy (MBCT) combines meditation practices from Mindfulness-Based Stress Reduction (MBSR) with cognitive behavioral therapy to improve mental health. Although there is evidence that MBCT provides a variety of mental health benefits, it is particularly designed to prevent depression relapse, which occurs in 80% of people with a history of two episodes of depression. MBCT reduces depression relapse rates by 30%, on average after an eight-week course, and has lower relapse rates than continuing antidepressant medication. However, it is unknown what should be done following the program to optimize its long-term benefit. The investigators plan to conduct a pilot study in preparation for larger-scale clinical trial to determine the most effective maintenance approaches once MBCT has ended. The investigators gathered stakeholder input from MBCT graduates and MBCT teachers to inform the development of maintenance programs for MBCT. From this the investigators formulated several components of a maintenance program for MBCT. This includes providing a booster course for people who have already completed the MBCT program. This will be delivered as a 4-week course, meeting weekly, followed by monthly sessions to help participants build self-efficacy and agency with regard to creating their own plan for relapse prevention. This booster course is adapted from a 12-week program developed by Dr. Willem Kuyken at the Oxford Centre for Mindfulness. The team is planning the following sessions: 1 Deepening mindfulness with a focus on interoceptive awareness. 2) Hedonic system: Appreciating the light within. This would focus on positive emotion. 3) Responding not reacting 4) Two themes: taking care of ourselves, taking care of others. Integrating lessons into daily life with regards to sleep, diet, healthy relationships, behavioral activation. The study will also provide monthly follow-up sessions. The current study is a pilot study aimed at refining the intervention, providing initial data on acceptability and feasibility, and preliminary use of outcome measures in the context of the proposed study design.
To evaluate the usability, feasibility, and acceptability of VRCT iteratively on 36 AD/ADRD individuals with mild to moderate CI.
This phase IIb trial studies the effect of a biobehavioral/cognitive (ABC) treatment on stress, depression, and anxiety in patients with stage IV lung cancer. Advanced lung cancer and stress or depression are associated with increased inflammation and decreased immunity. ABC is a combination of biobehavioral intervention, which studies the interaction between behavioral and biological processes, and cognitive therapy for the treatment for anxiety and depressive disorders. Giving ABC during lung cancer treatment may reduce stress, depression, and anxiety, and improve patients' quality of life and health.
This study is evaluating the effectiveness of recovery oriented cognitive therapy (CT-R) for patients with schizophrenia/schizoaffective disorder. To evaluate CT-R, the investigators are conducting a randomized controlled trial with patients from community mental health centers. Participants will be randomized to the CT-R condition, in which the participants will receive approximately 9 months of CT-R as an adjunctive treatment to current medical treatment, or to the continued usual care control condition. The primary outcome measure (positive, negative, and general psychopathology symptoms) as well as secondary measures (quality of life, self-esteem, social anhedonia, recovery, dysfunctional attitudes, resilience, internalized stigma, and hopelessness) will be measured at baseline, 4-5 months after the first therapy appointment, approximately 9 months after the first therapy appointment, and approximately 15 months after the baseline appointment.
The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.
Chronic spinal cord injury (SCI) pain is complex and difficult to treat. For individuals with SCI, pain often begins early in the course of their SCI and continues longitudinally. Unfortunately, SCI-related pain is frequently not responsive to medical treatment and medical treatments that are available and commonly used, such as opioids, have negative side-effects and risk of addiction. Nonpharmacological (non-medication) interventions to reduce chronic pain show promise both for individuals with SCI as well as other chronic pain conditions. Research on psychological interventions for chronic pain over the past two decades has consistently found these interventions to be more effective than no treatment, standard care, pain education, or relaxation training alone. However, many of these interventions are designed and implemented in outpatient settings after chronic pain has already developed. The development of early, effective, and preventative interventions to reduce the development of chronic pain has the potential to vastly improve quality of life for individuals with SCI. Having demonstrated the feasibility and acceptance of this treatment in an earlier study, the purpose of this randomized clinical trial is to compare the treatment of Hypnosis Enhanced Cognitive (HYPCT) therapy to Pain Education (ED) for reducing acute and chronic pain for individuals with new spinal cord injuries. The main goals of the study are to: * Aim 1: Test the effectiveness of HYPCT during inpatient rehabilitation for SCI compared to a ED for reducing current pain intensity. * Aim 2: Determine the post-intervention impact of HYPCT sessions compared to ED on average pain intensity. Participants will be asked to: * Complete 4 surveys over seven months * Complete pre and post treatment pain assessments for each of 4 treatment/control sessions Participants will be assigned to one of two groups for treatment and receive either: * 4 Hypnotic Cognitive therapy sessions or * 4 Pain Education sessions
The goal of this pilot study is to evaluate a bundle of implementation strategies at three Veteran Affairs Medical Centers (VAMCs) to facilitate the referral and adoption of a telehealth based, cognitive behavioral therapy program delivered by Health Psychologists for Veterans with chronic migraine to inform a future fully-powered hybrid type 2 effectiveness-implementation design. Veteran patients will be randomized to either the telehealth delivered CBT or usual care. Headache symptoms and severity will be reported using a VA text messaging application.
This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress. The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy. The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).
The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex) for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).
This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's disease.
This study will examine the effects of psychotherapy as treatment for PTSD. This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will receive 8 weeks of group therapy in MBCT or MRT. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide a saliva sample. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.
This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.
Chronic pain is prevalent and disabling in people with spinal cord injury (SCI). Medications alone often do not cure the pain. Pilot research suggests that training in the combination of self-hypnosis and cognitive therapy (HCT) can reduce chronic SCI-related pain. Thus far, people have learned HCT only through in-person training sessions plus home practice. The investigators think that training in HCT could be as effective if the training is done via videoconferencing. The purpose of this study is to find out whether people who are trained in HCT via videoconferencing achieve significant pain relief and other benefits compared to people who receive usual medical care (UC) for pain. Bettering our understanding of videoconferencing-delivered HYPNOCT can greatly increase treatment accessibility for individuals with SCI. Aim 1: To compare the efficacy of HYPNOCT vs. UC in adults with SCI and chronic pain. Investigators will compare the effect of the intervention on patient-reported average daily pain as measured by a 0-10 numerical rating scale. Aim 2: To examine sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) as potential effect modifiers. Hypotheses Primary study hypothesis Hypothesis 1a: There will be a significantly greater reduction in average daily pain intensity from baseline to the end of treatment in the HYPNOCT group compared to the UC group. Secondary study hypotheses Hypothesis 1b: Compared to the UC group, participants in the HYPNOCT group will show greater improvement in pain interference, depression, sleep quality, subjective disability, health-related quality of life, community participation, pain catastrophizing, pain acceptance, and global improvement. Hypothesis 2: The investigators will examine whether sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) exert a modifying effect upon outcomes.
The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. This study examines emotion regulation as a potential mechanism of action, at both the behavioral and neurobiological level, that carries forward to the postpartum period. A secondary mechanism of action to be explored is cognitive control. This study will also consider other potential influences on treatment response and psychiatric outcomes, including perinatal stress and depressive symptoms. The study population is pregnant women age 21-45.
Electrical activity in the brain known as "gamma" brainwaves help connect and process information throughout the brain. These gamma waves are diminished in Alzheimer's disease. New research in Alzheimer's disease mouse models shows that exposure to light flickering at the rate of 40 flashes per second or 40Hz increased gamma brainwaves and led to clearing of beta amyloid plaques in the brain, a key abnormality in Alzheimer's disease. This project will test the ability of a novel iPad App (AlzLife https://www.alz.life/) that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.
Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: * Brain MRI. Participants will lie on a table in a scanner. * Questions about their medical history and psychology symptoms * Tests of mood and thinking * Tests of brain activity. Participants may do tasks during these tests: * A cone with magnetic detectors is put on the head. * A cap with electrodes is put on the scalp. * TMS. A brief electrical current passes through a wire coil on the scalp. * A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. * There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. * Participants will receive rTMS and another therapy by computer. * For rTMS, repeated pulses will pass through the coil. * This is followed by up to 3 additional visits, when: * Participants will repeat Phase 1 tests * Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.
Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically combines mindfulness training and cognitive behavioral therapy and can increase resiliency. In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT resiliency program specifically for ICU nurses. For this aim, the investigators will engage multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot clinical trial to determine acceptability of the MBCT resiliency program and the control intervention. In this aim, the investigators will also identify the most feasible randomization level to minimize contamination between the control and intervention groups. Collectively, this proposal will pave the way for a properly designed large multi-center trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS symptoms; and allow nurses to more effectively care for patients in the challenging ICU environment.
The goals of this study are: 1) to investigate the efficacy of combining ketamine with intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to explore the relationship between any ketamine-induced changes in learning and memory and duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the study.
The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes in major depressive disorder (MDD) and cognitive therapy (CT).
This application seeks renewed support for MH59803, "Dopaminergic substrates of startle gating across species," to extend a clear path of "bench-to-bedside" progress towards a critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more effective treatments for this devastating disorder. MH59803 has investigated the neural regulation of laboratory-based measures of deficient information processing in SZ/SZA patients, using rodents and healthy human subjects (HS) to explicate the biology of these deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In its first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2 years of support, MH59803 studies moved "from bench-to-bedside," focusing on dopamine (DA) agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in cross-species studies. These studies detected biological markers that predict PPI-enhancing and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training in SZ/SZA patients. If confirmed in the present application, these predictions could help transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus reflects a logical progression of studies at systems and molecular levels, translated first to HS, and now to potentially transformative therapeutic models in SZ/SZA patients.
The current study will examine the use of a mobile electronic application used to deliver cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them to complete. The goal of this study is to determine if a) patients are able to use and adhere to a cognitive rehabilitation program delivered to their mobile device and b) to determine if patients can improve their language, attention, and memory by completing cognitive rehabilitation tasks assigned to them.
Pregnant women with histories of depression are at high risk of depressive relapse during the perinatal period, and options for relapse prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women. This study is the first phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD). It is being conducted in a collaboration between the University of Colorado, Emory University, and Kaiser Permanente at Colorado and Georgia.
Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women. This study is the second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).
This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from baseline to completion of treatment at 8 weeks in terms of depression severity using the Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of inflammation, over the same time period.
The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in individuals suffering from major depressive disorder (MDD).
This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT) for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a history of mood disorders. MBCT is a short-term group psychotherapy that has shown effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and cognitive-behavioral techniques.