Clinical Research Directory

Stepped Versus Stratified Care for Anxiety Disorders in Youth

The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question: • Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response? Researchers will compare two care models: * Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed. * Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary. Participants will: * Be randomly assigned to one of the two care models. * Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint. * Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment. * Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial. The primary objective of the study is: 1\. To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS). Secondary objectives of the study are: 1. To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment. 2. To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention. 3. To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome. 4. To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use. Participants will: * Undergo ICBT treatment for anxiety disorders during 12 weeks * Complete questionnaires at multiple time points throughout the study * Participate in follow-ups post-treatment and 3 months post-treatment * A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use

Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings

The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., psychologist, social worker). This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom. Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health. The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 2-arm clinical trial investigating capnometry-guided respiratory intervention (CGRI) for pathological anxiety. CGRI aims to raise end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions. Psycho-education about anxiety and its effects (PsyEd) will serve as a credible control comparator.

Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method

The study will compare the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder or dysthymia.

Mindful Self-Compassion for Anxiety Disorders and Depression

The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.

Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders

The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are: 1. Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures. 2. The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods. 3. Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE. 4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Clinical Trial of a Group Self-management Support Program for Anxiety Disorders

Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care. Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention. Methods. The trial is a pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between and within-subject variations in the analysis of the longitudinal effects of the intervention. Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.

VR Based Therapy to Treat Anxiety in Dual Diagnosis

Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group. However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process. This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy.

Testing a Precision Psychotherapy System for Low-income Patients

The purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.