Clinical Research Directory

Predictors & Mechanisms of Adolescent PTSD

This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally experienced stressful or traumatic event using a script-driven imagery task. The study evaluates whether repeated imaginal exposure is associated with changes in anxiety and physiological responses across sessions, and whether baseline patterns of threat reactivity and emotion regulation are associated with individual differences in response to the exposure task. Outcomes include self-reported anxiety, subjective distress ratings, and psychophysiological indices such as heart rate, skin conductance, and electromyographic activity. The goal of this research is to improve understanding of biobehavioral processes related to trauma exposure in adolescents and to identify potential predictors of response to exposure-based intervention components relevant to posttraumatic stress disorder (PTSD).

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

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.

Effectiveness of Cognitive Behavioral Intervention for Trauma in Schools (CBITS): A Study With Pakistani Adolescents

This study will evaluate whether a school-based counseling program, Cognitive Behavioral Intervention for Trauma in Schools (CBITS), helps reduce trauma-related symptoms and improve psychological functioning in adolescents in Pakistan who have experienced traumatic events. Students will first be screened to identify those with trauma exposure and related symptoms. Eligible students will receive the CBITS program, delivered at their school by the researcher. Researcher will measure changes in trauma-related symptoms and other psychological outcomes before and after the intervention to determine whether the program is effective for this population.

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 an active control group and a waitlist control group to see if the game leads to better emotional and mental health outcomes. Participants will: * Be randomly assigned to the game-based intervention group, the psychoeducation intervention group (as active control 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

Many Trauma-affected Youth Face Long Waits for Therapy, Worsening Stress, and Avoidance. CISS, a 90-minute Session Based on Stanford's Cue-Centered Therapy, Offers Coping Tools and Psychoeducation During This Gap. This Pilot Tests CISS's Feasibility, Acceptability, and Impact on 30-40 Adolescents.

Many young people who have experienced traumatic events such as sexual assault, domestic violence, serious accidents, or natural disasters face long waits before they can begin full trauma-focused therapy. During this waiting period, symptoms such as avoidance, anxiety, and distress may worsen, and many youth lose motivation or confidence to start treatment. The Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS) was designed to bridge this gap by offering a one-time, 90-minute session that teaches coping and self-understanding skills while youth are still on the waiting list. This study is a pilot feasibility trial conducted in partnership between Stanford University and the University of Auckland. The purpose of the study is to evaluate whether CISS is a practical, acceptable, and safe intervention for young people aged 13-18 who have been exposed to trauma and are currently waiting for or hesitant to begin full-length therapy within New Zealand Hapai Ora Clinics. Youth participants will meet once with a trained Hapai Ora clinician who will deliver the 90-minute CISS session. The session combines psychoeducation about trauma cues with skill-building strategies to improve coping, confidence, and readiness to engage in future treatment. Participants will complete short questionnaires before and after the session, and again at 3- and 6-month follow-ups. Measures will assess coping self-efficacy, treatment readiness, posttraumatic stress symptoms, and whether participants eventually begin full-length therapy. The study will recruit approximately 30-40 adolescents across Hapai Ora clinical sites in Auckland, New Zealand. All clinicians providing the intervention are qualified mental-health professionals trained in both CISS and child-safety protocols. Participation involves minimal risk-similar to discussing difficult topics in a supportive therapy session. Findings from this pilot study will help researchers understand whether CISS can be feasibly and safely delivered within public mental-health services, and whether it shows promise in helping young people build coping skills, reduce avoidance, and increase readiness to start therapy. The results will guide future larger-scale trials and inform the development of single-session, early-intervention approaches for trauma-exposed youth worldwide.

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.