Clinical Research Directory

Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress

The goal of this clinical trial is to compare the effectiveness of trauma-focused therapies for improving mental health symptoms and daily functioning in youth with chronic medical conditions who have experienced psychological trauma and trauma-related distress. The study evaluates two evidence-based cognitive-behavioral therapies - Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP) - delivered in group and individual formats to determine which approach, or combination of approaches, best reduces trauma symptoms and supports coping and adjustment. The study will also help researchers understand how to best support youth who continue to experience distress after an initial round of therapy. The main questions it aims to answer are: * Does SPARCS group therapy or UP group therapy lead to greater improvements in trauma symptoms and functional impairment? * For youth who do not show enough improvement after group therapy, does adding SPARCS or UP individual therapy lead to better outcomes? * Which sequence of group and individual therapies leads to the greatest improvements in trauma symptoms and functioning? Researchers will compare two evidence-based therapies currently offered at Ann \& Robert H. Lurie Children's Hospital of Chicago. Youth will first be randomly assigned to receive either SPARCS or UP in a group format. After completing group therapy, youth who still need additional support will be randomly assigned again to receive individual or family therapy using SPARCS or UP. This stepwise approach will help identify which sequence of therapies leads to the best overall outcomes for youth. Participants will: * Take part in group therapy sessions using either SPARCS or UP * For those needing additional support after group therapy, participate in individual SPARCS or UP therapy * Complete brief assessments of mental health and daily functioning at enrollment, and every 12 weeks thereafter for 48 weeks, as part of their regular care through Ann \& Robert H. Lurie Children's Supporting Purposeful Interventions \& Resilience in Trauma (SPIRIT) program

Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons

Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release. The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook This study will: * test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared to trauma-focused self-help, * evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and * measure the cost of the therapies and support strategies to help plan for future expansion. Incarcerated participants (N = 640; 50% female) will be enrolled from \~10 prisons in \~5 states, ensuring variability in population and setting characteristics. They will: * take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison) * complete CPT group therapy or self-help therapy * provide urine samples 3 months and 6 months after leaving prison Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = \~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.

Game Intervention for Resilience

The goal of this clinical trial is to learn if a game-based intervention can enhance psychological resilience and promote positive affectivity in adults who have experienced major life stress. The main questions it aims to answer are: * Does the game-based intervention improve positive affectivity and mental health compared to a waitlist control group immediately after the intervention and at 3-month follow-up? * Are the mental health benefits of the game-based intervention mediated by improvements in positive affectivity over time? Researchers will compare the game-based intervention to a waitlist control group to see if the game leads to better emotional and mental health outcomes. Participants will: * Be randomly assigned to either the game-based intervention group or the waitlist control group * Engage with the assigned program for 10 days within two weeks * Complete psychological assessments before and after the intervention, and again at 3-month follow-up

A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.