Clinical Research Directory

WRITE: Written Imaginal Thinking Exercise Study

The purpose of the study is to investigate and compare the effects of three different versions of a future imaginal writing exercise (worst-case scenario, neutral future scenario, best-case scenario) for individuals with elevated social anxiety symptoms. Participants (N=270) will be recruited through the online platform, Prolific, and will be randomly assigned to one of three writing exercise conditions. Participants will complete three study sessions across approximately three weeks. Study session 1 (T1) will consist of baseline assessments and pre-writing ratings, a future imaginal writing exercise, and then post-writing ratings. Study session 2 (T2) will occur approximately one week later and will consist of mid-study assessments and pre-writing ratings, a second, repeated future imaginal writing exercise, and then post-writing ratings. Finally, study session 3 (T3) will occur approximately one week later (approximately two weeks after T1) and will consist of follow-up assessments and repeated post-writing ratings.

iExposure Intervention for Social Anxiety

Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Despite the prevalence of SA, as few as one in five individuals receive care, due to limited access to evidence-based treatments. Additionally there has been a notable increase in social anxiety since the start of the COVID-19 pandemic. This proposal will use iExposure to develop a personalized mechanism-focused approach to optimizing treatment response for individuals with social anxiety by testing standard iExposure against two augmentations that incorporate distinct attention mechanisms (attention guidance and attention control).

Online Study on the Impact of a Self-Help Tool for Social Anxiety

The goal of this clinical trial is to understand which individuals benefit most from an internet-based cognitive behavioral intervention for social anxiety. Adults aged 18-65 will complete a self-guided online program designed to reduce anxiety symptoms. The investigators will use a combination of self-reported clinical information and data from computerized decision-making and cognitive tasks to predict changes in symptom scores from the intervention.

Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety

Efficacy of an optimized exposure therapy training is investigated in individuals with heightened social anxiety. Participants will undergo a one-session standardized exposure training, followed by either standard or positive mental rehearsal of the exposure experience. The efficacy is measured by symptom improvement according to subjective ratings one week later.

The Efficacy of Prospective Mental Imagery in Enhancing Approach Motivation Among Socially Anxious Individuals

The efficacy of an online intervention aimed at enhancing approach motivation and behavioral engagement in confronting anxiety-inducing social situations is examined among individuals with elevated social anxiety. Participants will receive psychoeducation, followed by either a prospective mental-imagery task or a verbal reasoning task. Efficacy of the intervention is measured by ratings of experienced and anticipated pleasure, approach motivation and self-reported engagement with feared situations one week later.

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.

Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety

This study aims to investigate the potential of supplementing psychotherapy with breathing techniques as a new online therapeutic approach to reduce social anxiety (SA). Clinically significant SA affects a substantial portion of the population (about 13%) and is associated with strong negative feelings of shame and anxiety in social settings. Such emotional distress leads to impairment in personal, relational, and professional functioning and may result in increasing degrees of social isolation. In response to the demand for improved treatments for SA, this project aims to explore the efficacy of a novel treatment approach integrating online psychotherapy with online breathwork sessions designed to induce ASC. We will recruit 96 individuals with SA, who will be randomly divided into two groups: one group will receive the new combined breathwork-assisted psychotherapy, and the other an active control intervention that does not induce ASC. Over the treatment duration, the effectiveness of these treatments will be closely monitored using established psychological scales and by observing patients in live interactions before and after therapy. This project is expected to open the way to a more accessible and effective treatment option for a large group of people struggling with SA. More broadly, the findings will also contribute to our understanding of how ASC, induced through breathing techniques, can be used therapeutically. This could change the way a variety of mental health conditions (e.g., other anxiety-related conditions and depression) are treated, making a substantial impact on public health and the way mental health disorders are approached and managed.

Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications

Social Anxiety Disorder (SAD) is one of the most widespread mental illnesses and it has previously been shown that online therapy and online self-help tools such as the one investigated in this study can be successful in reducing not only symptoms of SAD but also symptoms of depression and increase the quality of life of participants. A substantial concern with digital health intervention tools is data security and privacy as many such tools have been found to be unsafe and easy targets for hacker attacks, potentially endangering personal (health) data of the users. For this research project, an internet-based program targeting social anxiety has been developed that can be used completely anonymously (i.e., without collecting an email address or other information that can or could potentially identify users). This new anonymized version will be compared in a partially randomized patient preference trial with an already well-evaluated version in which, as is common in other digital health applications, personal data such as the email address or other information from the users is used, for example, for login. Study objectives: 1. To investigate the efficacy of a completely anonymous version of the program "JOURNeY" based on cognitive behavioral therapy (CBT) and compare it to an already evidence-based non-anonymous version of the program regarding primary social anxiety symptoms, and secondary outcomes such as depressive symptoms, quality of life, usability, adherence to the program, internalized stigma, attitudes on help-seeking, and personality functioning. 2. To investigate patients' preferences and the influence of patients' preferences on outcome. 3. To explore how patient characteristics are associated with participants' preferences.

Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth

This randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a mobile-based psychoeducation program (OkeyMind) in mitigating symptoms associated with social anxiety among youth. Participants will be recruited and screened onsite and then randomized to the intervention group and the waiting list control group. The intervention group will receive a one-month mobile psychoeducation program (OkeyMind), which includes both psychoeducation and meditation components, with all content fully automated. The waiting list control group will receive the same intervention after 3 months. Participants will be followed up at three time-points: baseline, 1 month, and 3 months Results: The investigators will recruit 180 participants, with 90 in each group. The primary effectiveness outcomes are the scores of SPIN and PHQ-9, and the cost-effectiveness outcomes is measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L). This research evaluates the effectiveness and cost-effectiveness of OkeyMind, a mobile-based psychoeducation program for youth with social anxiety. OkeyMind might be a promising strategy for combating social anxiety, especially in low- and middle-income countries with limited medical resources. By leveraging mobile technology, it aims to provide accessible, cost-effective mental health support, improving outcomes on a broader scale.

Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety

The objectives of the study are to 1) to translate and adapt iCBT Shyness Program to the Canadian context; 2) to examine the completion and effectiveness of the Canadian adapted, including the French translated and English iCBT Shyness Program, in improving SAD symptoms; 3) to explore barriers and facilitating factors to the program's implementation. The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways (recommended and self-referrals). The project will be conducted in two Canadian provinces: Quebec (Montérégie) and Ontario. Prior to implementing the iCBT Shyness Program, it will undergo an initial adaptation to the Canadian context and focus groups will be conducted with key actor groups to discuss the adaptations to the graphics, narration of the modules, and this to better reflect varying sociocultural context among Canadian French- and English-speaking populations. We will then evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial. As a last step to this trial, semi-structured interviews will be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program.

Families, Children and Teachers Thriving Together

The current study examines the impact of ParentCorps in high-poverty district schools in New York City (NYC). The study is conducted within the context of the NYC Department of Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to strengthen family engagement and support parents and teachers in creating safe, nurturing and predictable environments for young children. All parents of Pre-K students in the 81 district schools will be invited for them and their Pre-K children to participate in the study, which includes 2 school-based assessments in Pre-K over a 10-month period and 1 school-based assessment at the end of Kindergarten, and teacher ratings of children in Pre-K and Kindergarten. Additionally, parents will be invited to consent to the use of their children's NYC DOE administrative records from Pre-K through grade 5 for the purposes of this study. Parents will also be invited to participate by completing surveys with NYU study staff. Parents will be consented to complete two surveys when their child is in Pre-K. Parents may be randomly selected to complete a third survey when their child is in Kindergarten or to participate in a focus group with other parents.

Evaluating the Efficacy of Culturally Adapted iCT-SAD

The study will adapt and implement a Pakistani version of Internet-delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD), assessing its effectiveness in reducing social anxiety symptoms among Pakistani individuals.

School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder

The goal of this randomized controlled trial is to find out whether the brief, 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is more effective than standard counseling (SC) to treat Social Anxiety Disorder (SAD) among 12 to 17-year-old adolescents with SAD. Potential participants for the study are identified from school health and well-being services (SHWS). The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS. SC will be provided by non-method-trained SHWS professionals (i.e. school nurses, social workers or school psychologists) according to their routine counselling practice. The main research questions of the study are: 1. Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety? 2. Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD? 3. Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms, interference in daily functioning due to worry or fears, and for increasing general well-being, positive mental health, and for improving the quality of life among adolescents with SAD? Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents. Participants will: * be treated either with DOCT-SAD or SC for 10 weeks. * be followed up and assessed clinically at six-month and twelve-month follow-up points.

Reducing Social Avoidance Among Adolescents With Special Educational Needs

The goal of this clinical trial is to examine the effectiveness of a Virtual Reality (VR) social avoidance intervention in reducing social avoidance symptoms among adolescents with special educational needs. Participants will complete tasks in the VR scenario with increasing difficulty and learn that they can cope in situations that they previously avoid. We hypothesize that, comparing with usual care (i.e. waitlist control), the intervention group will experience a significant reduction on social avoidance symptoms after treatment and this benefit will persist till 1-month follow-up.

UniVRse: VR-CBT for Students With Social Anxiety

The goal of this pilot randomised controlled trial is to evaluate the effectiveness of the UniVRse VR-CBT programme in students with social anxiety. The aims of this trial are: 1. To determine whether a full trial is justified; 2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial; 3. To address questions concerning study recruitment, retention, and acceptability. Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.

Virtual Reality Exposure for Socially Anxious Adolescents

Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition. It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being. Moreover, the study has the following (secondary) objectives: * To elucidate potential working mechanisms of VRE and IVE * To identify predictors of adolescents' response to VRE and IVE * To assess to what extent adolescents accept VRE and IVE and how they experience it

Delving Into Participation Patterns in Social Anxiety Studies

The study seeks to delve into the firsthand experiences of patients diagnosed with social anxiety who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future social anxiety patients and play an active role in advancing medical research.