ERP to Improve Functioning in Veterans With OCD
NCT05240924 · Obsessive Compulsive Disorder (OCD), Comorbid Post-Traumatic Stress Disorder and OCD
RecruitingObsessive compulsive disorder (OCD) is a debilitating psychiatric illness impacting work, social, and family functioning. Exposure and Response Prevention (ERP) is the sole evidence-based psychotherapy for OCD; however, no randomized controlled trials (RCTs) have examined the effectiveness of ERP among Veterans or individuals with both OCD and posttraumatic stress disorder (PTSD). This 4-year Hybrid Type I trial will compare outcomes of ERP to those of a control condition among Veterans with OCD. Primary and secondary aims will examine whether Veterans' functioning, quality of life, and OCD symptoms differ between the ERP and control in the full sample of Veterans with OCD, and in the half of the sample with both OCD and PTSD. The tertiary aim is to conduct a mixed-methods formative evaluation of the implementation potential of ERP in VA mental health settings.
PhaseNA
TypeInterventional
Age18 Years
WhereEast Orange, New Jersey, United States + 17 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.
PhaseNA
TypeInterventional
Age18 Years – 50 Years
WhereHouston, Texas, United States
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use
RecruitingIndividual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
NCT05893485 · Music Therapy, Preterm Premature Rupture of Membrane (PPROM)
RecruitingTo evaluate the effects of music therapy in the care of antepartum mothers admitted for long-term hospitalization due to the high-risk status of their pregnancy. The investigators speculate that mothers who receive music therapy will be more successful in forming positive coping habits, bonding with their infant, and increasing the length of incubation during their pregnancy. Furthermore, there is no research that correlates music therapy applied to stress reduction, increased coping, and increased caregiver-infant bonding prior to birth within one protocol. However, there is a significant amount of research supporting music therapy efficacy with neonatal intensive care unit infants and caregiver bonding post-partum as well as improved physiological signs of stress in infants in the post-partum period.
PhaseNA
TypeInterventional
Age18 Years – 64 Years
WhereHouston, Texas, United States
SponsorChristina Chianis Reed
▾Tap for detailsClick for full details — eligibility, all locations, contacts TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
RecruitingThis clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.
PhasePhase 2
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
NCT06537128 · Autism Spectrum Disorder, Autism,
Anxiety RecruitingAnxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.
PhaseNA
TypeInterventional
Age11 Years – 17 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
RecruitingThe SEQUOIA-1 study evaluates the effectiveness of Artificial Intelligence (AI) in measuring depression and anxiety severity in adults. Investigators from Deliberate Solutions, Inc. and Baylor College of Medicine are conducting this study to determine whether AI can provide reliable clinical assessments of mood and anxiety disorders. In clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings. To address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. The primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments. During the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer. All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians. The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereHouston, Texas, United States
SponsorDeliberate Solutions Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
NCT06596447 · Obsessive Compulsive Disorder (OCD), Neuromodulation
RecruitingWe will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability. We will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab/clinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms. Subjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2). At home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.
Phase—
TypeObservational
Age18 Years – 64 Years
WhereHouston, Texas, United States + 1 more
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.
PhaseNA
TypeInterventional
Age18 Years – 50 Years
WhereHouston, Texas, United States
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort
NCT07575815 ·
Anxiety, Radiation
RecruitingThis is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.
Phase—
TypeObservational
Age2 Years – 12 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
RecruitingAnxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed. Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET. This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
PhaseNA
TypeInterventional
Age7 Years – 17 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking
NCT06416059 · Alcohol Abuse,
Anxiety RecruitingThe purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.
PhaseNA
TypeInterventional
Age21 Years
WhereHouston, Texas, United States
SponsorUniversity of Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
RecruitingThe goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are: * Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life? * For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life? * Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group? Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WherePhoenix, Arizona, United States + 29 more
SponsorVanda Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Application of Virtual Reality Technology to Treatment of Social Anxiety
NCT06845488 · Autism Spectrum Disorder,
Social Anxiety Disorder RecruitingThe purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Personalized Feedback Intervention for Latinx Drinkers With Anxiety
NCT05246202 · Alcohol Abuse,
Anxiety RecruitingThe purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety.
PhaseNA
TypeInterventional
Age21 Years – 75 Years
WhereHouston, Texas, United States
SponsorUniversity of Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
NCT04479696 ·
Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma
RecruitingThis trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
NCT05609916 · Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children
RecruitingThe purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.
PhaseNA
TypeInterventional
Age7 Years – 17 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pilot Study of Virtual Reality Therapy for Students With Anxiety
RecruitingThe purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.
PhaseNA
TypeInterventional
Age18 Years – 30 Years
WhereHouston, Texas, United States
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
NCT05809115 · Food Insecurity,
Depression,
Anxiety RecruitingThe main goal of this research is to help families who are experiencing food insecurity (FI) and help mothers with depression. The next goal is to provide other resources to help with household needs like rent or utility assistance, health insurance, anxiety, and depression. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.
Phase—
TypeObservational
Age18 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts