Clinical Research Directory

Psychological Prehabilitation for Complex Gastrointestinal Surgery

The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. The program is called PREPARE-GI. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery. Many people who need complex GI surgery have been through a lot. They may have had many surgeries, hospital stays, or emergency visits. These experiences can leave lasting stress, worry, and low mood. These feelings can make recovery from surgery harder. The main questions this study aims to answer are: * Can researchers sign up enough participants, and will participants attend the program sessions and finish the surveys? * Does the program lower stress, worry (anxiety), and low mood (depression)? * Does the program lower pain and improve quality of life after surgery? * Does the program shorten hospital stays or lower return visits to the hospital or emergency room? Researchers will compare two groups. One group will take part in the PREPARE-GI program. The other group will get usual surgical care. Participants will be placed in a group by chance, like flipping a coin. Adults may be able to join if they: Are 18 or older Have complex GI surgery planned at Northwestern Memorial Hospital at least 8 weeks away Score high on a short survey about stress from past experiences Can complete the study in English All participants will: Answer survey questions about stress, worry, mood, body symptoms, pain, and quality of life. They will do this before surgery, then 1 month and 3 months after surgery. The surveys will take about 20 to 30 minutes to complete. Rate their pain on a scale from 0 to 10 after surgery. Allow researchers to review their medical records for information about their surgery and recovery. Participants in the program group will also meet one-on-one with a licensed psychologist for 8 sessions. Each session lasts about 1 hour and will take place either in person or by secure video from home. In the sessions, participants will learn skills to manage stress, handle difficult feelings, and prepare for surgery and recovery. Participants will be in the study for about 5 months. Participants in the program group will spend about 9 to 10 hours on the study. Participants in the usual care group will spend about 1 to 1.5 hours. This is a small study with 20 participants. The results will help researchers plan a larger study in the future.

Effect of cTBS on Startle and TMS-evoked BOLD

The right dorsolateral prefrontal cortex (dlPFC) is increasingly being targeted with transcranial magnetic stimulation (TMS) to reduce anxiety expression; however, there is little mechanistic evidence supporting an optimized treatment protocol. Thus, the objective of the current project is to develop an interleaved TMS/fMRI that can assess the effect of neuromodulatory (potentially therapeutic) TMS protocols on neural and behavioral measures related to anxiety expression. PUBLIC HEALTH RELEVANCE: These results will yield direct evidence that 1 Hz and cTBS modulate brain activity associated with anxiety expression and regulation, thus informing novel TMS based anxiety treatments.

Relaxation Exercise Interventions for Individuals Who Have Undergone Urinary Tract Stone Surgery

This randomized controlled trial aims to evaluate the effects of the Benson relaxation exercise and the Jacobson relaxation exercise-administered to individuals undergoing urinary tract stone surgery-on pain, vital signs (blood pressure, pulse, respiratory rate, oxygen saturation, and body temperature), and anxiety levels. Postoperative pain and anxiety are common issues that can negatively affect vital signs. Non-pharmacological interventions, such as relaxation exercises, may help reduce these adverse effects. Participants will be randomly assigned to one of three groups: the Benson relaxation exercise group, the Jacobson relaxation exercise group, or the control group receiving routine postoperative care. Relaxation exercises will be performed two times a day for 15 minutes each, provided the individual's general condition is stable. Outcomes such as pain, anxiety, and vital signs will be measured at baseline (pre-test), on postoperative day 0, and on postoperative day 1 after each session. The findings of this study are expected to provide evidence regarding the effectiveness of relaxation exercises as supportive nursing interventions in the postoperative care of patients undergoing urinary tract stone surgery.

The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Amplification of Positivity for Alcohol Use

The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).

The Effect of Preoperative Hugging With Family Members on Preoperative Anxiety Levels and Postoperative Pain

The aim of this randomized prospective study is to examine the effect of preoperative family hugging (for at least 20 seconds) on preoperative anxiety levels and postoperative pain. The main question the study aims to answer is: * Does preoperative hugging reduce anxiety levels? * Does preoperative hugging reduce postoperative pain scores? Anxiety and pain scores will be evaluated between patients who hugged and those who did not hug their family members before surgery, and whether hugging has an effect will be assessed.

Digital Single-Session Cognitive Behavioural Therapy in Healthy Adults

The goal of this study is to learn if digital single-session cognitive behavioural therapy can treat mental health in adults. The main question it aims to answer is: * Does digital single-session cognitive behavioural therapy improve mental health in participants? Researchers will compare digital single-session cognitive behavioural therapy to a control intervention (digital memory task) to see if digital single-session cognitive behavioural therapy works to treat mental health. Participants will: * Complete either the digital single-session cognitive behavioural therapy or a digital memory task. * Complete some mental health questionnaires.

Lakota Family Acceptance Project Pilot RCT

Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. The study will include \~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. The researchers will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.

Pramipexole to Enhance Social Connections

This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling. The study also measures the time spent on blood sampling.

Virtual Reality Therapy to Improve Arthroplasty Outcomes

Virtual reality (VR) has recently emerged as a non-medication-based method to manage anxiety. The patient wears a VR headset and is offered an immersive environment with hypnotic components with sound and imagery in a 3D environment. VR creates an immersive 3D environment and diverts attention away from worrying thoughts (anxiety) and pain and has been found useful to manage minor procedural pain and related anxiety. This is a pilot feasibility trial to evaluate the effectiveness of VR in improving patient related outcomes (PROM) after joint replacement surgery.

AI-Guided Personalized Relaxation for Hemodialysis Patients

Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Artificial intelligence (AI)-guided interventions may provide personalized psychological support and promote adaptive coping through tailored relaxation strategies. This randomized controlled mixed-methods trial evaluates the effectiveness of an AI-guided personalized relaxation intervention delivered through a smartphone application among adults receiving maintenance hemodialysis. Participants are randomly assigned to either an intervention group receiving AI-guided personalized relaxation in addition to routine hemodialysis care or a control group receiving routine care alone. The 6-week intervention includes individualized breathing exercises, mindfulness practices, guided imagery, progressive muscle relaxation, and adaptive feedback generated according to participant characteristics, emotional responses, and engagement patterns. The primary outcome is health-related quality of life measured using the Kidney Disease Quality of Life-36 (KDQOL-36™). Secondary outcomes include anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7), coping strategies measured by the Brief COPE Inventory, and user acceptance of the AI-guided intervention. Qualitative interviews are conducted with intervention participants to explore their experiences, perceived benefits, feasibility, and acceptability of the intervention. The study aims to determine whether AI-guided personalized relaxation can improve quality of life, reduce anxiety, and enhance coping among patients undergoing maintenance hemodialysis while providing insight into the acceptability and feasibility of integrating AI-supported psychosocial interventions into routine dialysis care.

Surgical COrncerns and Psychological Evaluation of Patients Undergoing Elective Surgery

This study wants to obtain more information regarding the patient's concerns since concerns of the patient about the procedure is found as a predictor for the development of chronic post-surgical pain. This step is crucial in translating early identification of a high-risk population into preventive policies. Using a semi-structured interview, the investigators aim to gather this additional information, which is essential in the development of an (individualized) biopsychosocial care pathway in the future.

THE EFFECT OF VIRTUAL REALITY USE IN CYSTOSCOPY ON PAIN, ANXIETY, AND COMFORT: A RANDOMIZED CONTROLLED TRIAL

This study aims to evaluate the effects of virtual reality (VR) distraction on pain, anxiety, and comfort levels patients undergoing cystoscopy. Cystoscopy is a common diagnostic procedure in urology that can cause physical discomfort and anxiety in patients. This randomized controlled trial assigns eligible participants to either an experimental group receiving VR video distraction during the procedure or a control group receiving standard care without VR intervention. Pain, anxiety, and comfort levels are assessed and compared between the two groups using standardized measurement tools.

Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum

Background: Making decisions during daily life is a complicated behavior. Even simple choices can be affected by a range of emotions, stresses, and moods. Mental health issues such as depression and anxiety can lead people to make decisions that have negative effects on their lives. Learning how changes in feeling affect a person's decisions may help researchers find ways to help them make more positive choices. Objective: To learn how changes in a person's feelings and emotions affect their decisions. Eligibility: People aged 18 to 55 years who are healthy or who have some level of depressive, anxiety, substance-related, or addictive disorders. Design: All study activities can be done remotely; participants may use a smartphone app, a website, or telehealth. Participants will have a baseline visit. They will complete tasks that require decisions; these tasks are like games they play on their phone. They will also answer questions about their habits, how they feel, their sleep quality, and any problem behaviors. They may wear a smartwatch during the study; it will record data such as their movements and heart rate. For 12 weeks, a study app will prompt participants to respond. They will be asked to answer questions about how they are feeling, any problematic behaviors, or big life events; they will be asked to complete tasks that require making decisions. They may record a video or audio clip describing their day and how they feel. For 3 of the 12 weeks, participants will get prompts up to 6 times per day. For 9 weeks, they will get up to 3 prompts per day. They will have an end-of-study visit to discuss their experiences.

Improving Mental Health Among the LGBTQ+ Community

The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.

The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network

Depression, anxiety, and related disorders such as post-traumatic stress and obsessive compulsive disorder affect about 20% of pregnant and postpartum people. When not treated properly, these issues negatively impact not only affected people, but also their children's health and development. Only 1 in 5 receive adequate treatment, so identifying new system-wide approaches to reliably deliver recommended care to perinatal mental health patients all is a crucial health care priority. The Pregnancy and Postpartum Mental health Optimization Virtual Intervention Network (MOVIN) is a scalable perinatal mental health platform building on the evidence-based Collaborative care delivery model. MOVIN's online platform allows patients to connect with a care coordinator to co-develop personalized treatment recommendations, in collaboration with their primary care clinician and a perinatal psychiatrist when needed; progress is tracked to re-evaluate.

AI-Assisted Patient Education Before Suturing in Minor Trauma

Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. However, the realities of emergency department practice, including crowding, high patient volume, staff shortages, and increased workload, may limit effective nurse-patient communication and comprehensive patient education. Patients awaiting suturing for minor trauma often experience uncertainty, prolonged waiting, fear of the procedure, and concern about pain. These factors may increase anxiety, which can further intensify pain perception and negatively influence patients' cooperation with treatment and satisfaction with care. Previous reports indicate that many patients waiting in emergency departments seek information about waiting times, care processes, and their medical conditions, highlighting a substantial need for accessible and reliable information. During this waiting period, patients may increasingly use artificial intelligence-based digital resources to obtain information about their health condition and the procedure they are about to undergo. However, information generated by artificial intelligence may be inaccurate, incomplete, or insufficiently tailored to the clinical context. Therefore, such information should be reviewed and validated by healthcare professionals before being provided to patients. This study aims to evaluate the effect of an artificial intelligence-assisted patient education material delivered during the pre-suturing waiting period on pain and anxiety levels among patients with minor trauma in the emergency department. It is also expected that the educational material developed within the scope of this study may contribute to patient education and supportive care in emergency department settings.

Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Objective: This study aims to evaluate the effectiveness of Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Bacillus coagulans, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.

2D:4D Ratio in Relation to Anxiety and Stress Among Anesthesiology Residents

Anesthesiologists are exposed to substantial occupational stress, making their psychological well-being essential for both personal health and optimal patient care. Early identification of mental health disorders among healthcare professionals is important for improving well-being and maintaining healthcare quality.

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.

Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.

Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma

This study is testing whether combining a rapid form of transcranial magnetic stimulation (TMS), an oral medication called d-cycloserine (DCS), and therapy can improve brain flexibility and emotional control in adults experiencing moderate-to-severe depression, anxiety, or trauma symptoms. TMS is a non-invasive treatment that uses gentle magnetic pulses to stimulate specific areas of the brain. In this phase of the study, all participants receive active accelerated TMS (delivering multiple brief sessions in a single day) along with DCS, a medication that helps enhance brain learning and plasticity. Participants will be randomly assigned to have TMS directed at one of two brain targets: a region called the precuneus (identified using personalized brain scans) or the dorsolateral prefrontal cortex (a standard area for mood treatment). Afterward, participants are randomly assigned to complete three weeks of either therapist-led talk therapy (a modified Unified Protocol) or self-guided educational videos and readings. The main goals are to determine which brain stimulation target works best and to see whether therapist-led therapy leads to more lasting symptom relief and brain changes compared to self-guided education.