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103 active trials for Obsessive Compulsive Disorder

Developing Brain, Impulsivity and Compulsivity

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic and brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6-80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may have a magnetoencephalography scan. It records brain activity. Participants will sit in a room. A 'cone' of magnetic field detectors will be lowered around their head. They will rest and play a game. Participants may ask family members to join the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.

Start: June 2021
Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.

Start: June 2021
Microbiome in Obsessive-compulsive Disorder

Background: Humans live in symbiosis with microbes and their implication for health and disease is evident. The importance of microbiome-gut-brain axis in psychiatric disorders is an area of increasing research interest. OCD is a promising target for microbiome research as Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/ Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are reactions to infectious agents precipitating acute onset of severe OCD symptoms. Furthermore, preliminary evidence has associated probiotic treatment with alleviation of OCD symptoms. We propose the first clinical study on the microbiome and its effects on OCD patients. Aim: To analyze the gut microbiota in patients with OCD compared with healthy matched controls and assess changes in microbial composition following treatment. Outcome measures: Differences in alpha diversity (number of observed species and Chao-1 estimator), beta diversity (UniFrac distances), and taxa abundance of bacterial groups (at the phylum, class, order, family, and genus levels) and severity of OCD symptoms. Methods: Our aim is to enroll 30 OCD patients and 30 matched controls. Shotgun metagenomic sequencing will be used. Sequenced data will be processed followed by non-parametric statistical testing. Significance: gut microbiome in patients with OCD beofre and after ERP treatment has never been done before. The microbial composition may impact on OCD symptoms, severity, and chronicity and could inform future therapeutic possibilities.

Start: December 2018
Cognitive Behavioral Group Treatment for Obsessive-compulsive Disorder in Youth

Obsessive-compulsive disorder (OCD) is a debilitating disorder characterized by unwanted intrusive thoughts and disrupting repetitive rituals. Epidemiological studies estimate the prevalence of impairing OCD to be between 0.5-3.0 % in pediatric populations. Although OCD in youth is associated with substantial distress and functional impairment, access to evidence-based psychosocial treatments is limited. This is largely due to the fact that few clinicians are trained in the delivery of evidence-based treatments, such as exposure-based cognitive-behavioral therapy (CBT). Therefore it is of great importance to develop treatment programs that utilize therapist resources in the most efficient way. Exposure-based CBT delivered in the context of a group, rather than individually, is one such option. However, there are currently no evidence-based group OCD treatment manuals for youth available to clinicians in Denmark. Therefore this project addresses an important clinical need. We evaluate a group-based CBT protocol for the treatment of youth with OCD, benchmarking treatment outcomes against data from a previous trial evaluating individual-based CBT and by comparing outcomes against a short waiting list period. Further, we will explore the impact of group-based CBT over a 36-month open follow-up interval on general functioning, relapse, recurrence rates, and the need for other treatments. Finally, a brief youth questionnaire assessing overall symptom severity relevant for the evaluation of outcomes in pediatric OCD will be translated and validated for future clinical and research use in Denmark. The project will include 72 adolescents with a primary diagnosis of OCD referred for assessment and treatment at the OCD Clinic at Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Denmark. For benchmarking of treatment outcomes, the project will compare the results from the group-based CBT with data from 45 Danish patients previously enrolled in the individual-based CBT of the Nordic Long Term OCD Treatment Study at the same clinic.

Start: August 2017
Improving Access to Child Anxiety Treatment

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

Start: July 2018
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD

Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment . The disorder cause high personal, societal and economic costs . Current available treatments for OCD show moderate response rate and high rate of symptom relapse. The purpose of the current study is to explore new alternative options for the treatment of OCD that can widely and continuously benefit patients. Specifically, The aim of this study is to investigate the feasibility, safety and efficacy of psychotherapy assisted psilocybin for treatment of severe OCD. Previous research has shown safety of treatment and high efficacy in reduction of anxiety and depression symptoms. However, only one study has evaluated the use of psilocybin for OCD patients. The protocol includes 15 therapeutic sessions, of which 12 are one-hour sessions for psychological preparation and integration, and three are eight hours' experiential sessions under the influence of psilocybin. The research will include 15 participants diagnosed with severe OCD, with at least one treatment failure. Assessments will be based on comparing ratings of the main outcome measure (Y-BOCS), at baseline, at the middle and at end of treatment. Other assessments will include data on side effects- to evaluate safety, and possible spiritual variables underlying change in symptoms via standardized questionnaires.

Start: December 2021