Clinical Research Directory

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.

PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas

Overview: People with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. This pilot study investigates whether two established trauma therapies can be delivered safely and acceptably to young adults with psychotic disorders receiving care in the OPUS early-intervention program. Objectives: The main aim is to evaluate the feasibility and acceptability of two trauma-focused treatments-Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-in patients with psychotic disorders and post-traumatic stress symptoms. The study is not designed to test treatment efficacy but to determine whether a larger randomized controlled trial is practical. Study Design: This is a pilot and feasibility study. Twenty OPUS patients with a diagnosis within the schizophrenia spectrum and clinically relevant PTSD symptoms will be randomly assigned to either PE or EMDR. All participants continue their usual OPUS care while attending weekly trauma-focused therapy sessions. Assessments: At baseline and follow-up, participants complete clinical interviews and questionnaires assessing trauma symptoms, psychotic symptoms, functioning, well-being, recovery experiences, and possible negative effects. Instruments include the PCL-5, CAPS-5, Mini-TALE, PANSS-6, PSP, WHO-5, Brief INSPIRE-O, NEQ, and CSQ. Primary Feasibility Outcomes: Recruitment: At least 80% of the planned sample enrolled within 6 months. Retention: At least 70% completing ≥12 therapy sessions. Acceptability: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ). Eligibility: Inclusion: Age ≥18 Diagnosis within the schizophrenia spectrum (ICD-10: F20-F29) PTSD symptom score \>31 on PCL-5 Current OPUS patient Sufficient Danish language skills Exclusion: Substance use that prevents participation (e.g., attending sessions intoxicated) Severe cognitive impairment Recent changes in antipsychotic medication (within 1 month) Risks and Safety: Temporary increases in PTSD symptoms may occur when beginning trauma therapy; this pattern is well documented and typically followed by improvement. Previous studies show no higher risk of serious adverse events among patients with psychosis receiving trauma treatment compared with those who do not. Participants are closely monitored, and the study team works in continuous collaboration with OPUS clinicians. If a participant experiences significant clinical deterioration, the therapy can be paused or stopped, and supportive measures will be provided. Potential Benefits: Participants may experience a reduction in trauma-related symptoms and gain access to a treatment that is not otherwise routinely offered to patients with psychotic disorders. The study may help improve future care for this underserved population. Funding: The study is funded by the Nektar Foundation and conducted at the CORE Research Unit, Mental Health Services Copenhagen.

Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms

The proposed study will collect novel data evaluating the feasibility of a neurofeedback training program delivered to prospective clients with a history of clinically concerning trauma-related mental health symptoms who are on a wait list to receive obsessive compulsive disorder-specific psychotherapy at an outpatient mental health clinic. This study will evaluate the influence of neurofeedback training on participant's overall sense of well-being, and additionally, whether any enhanced well-being is subsequently associated with positive changes in symptoms of obsessive compulsive disorder, post-traumatic stress, dissociation and other trauma-related mental health symptoms, emotional regulation, etc.

A Feasibility Trial of Eye Movement Desensitization and Reprocessing Therapy- Integrative Treatment Group Protocol for Ongoing Traumatic Stress In Road Traffic Accident Survivors for Reduction of Post-traumatic Stress Symptoms

Road traffic accidents (RTAs) are a significant public health concern globally, accounting for a substantial proportion of morbidity and mortality. This study evaluates the feasibility and acceptability of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in the reduction of posttraumatic stress symptoms, depression, and anxiety, while improving the quality of life in individuals who have experienced traffic accidents. Using a randomized control design, participants aged 18-45 will be assessed at three-time points: pre-treatment, post-treatment, and one-month follow-up. The study employs the DASS-21, UIES-R, and WHOQOL-BREF as evaluation measures. Findings aim to expand evidence on trauma-focused interventions and explore their applicability in culturally diverse, resource-constrained settings.

Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer

Cancer is still the second leading cause of death worldwide with approximately 9.6 million deaths per year. Gynecological cancers, which are the most common type of cancer among women, significantly affect the quality of life by disrupting the functions of the reproductive system of women. Endometrial cancer has an important place due to its prevalence in our country and worldwide. Although stress factors related to endometrial cancer may continue after the completion of treatment, this situation has the potential to negatively affect the psychological and physiological health of women. This research is a randomized controlled trial aiming to evaluate the effect of motivational interviewing applied to women who completed endometrial cancer treatment and were followed up in the outpatient clinic on post-traumatic stress symptoms and post-traumatic growth. Simple randomization method will be used in the study. The sample size to be included in the study was determined as 66 participants in total, 33 in the intervention group and 33 in the control group. In the study, the effectiveness of motivational interviewing technique application in women with endometrial cancer will be evaluated based on evidence using Post-Traumatic Stress Disorder Checklist for DSM-5, Post-Traumatic Growth Scale and Ways of Coping Scale. Research data will be collected from women who meet the inclusion criteria at Akdeniz University Hospital Gynecology and Obstetrics Clinic between January 2 and August 31, 2025. The motivational interviews planned to be implemented as an intervention method in the research aim to reduce post-traumatic stress symptoms, develop coping strategies and increase the level of post-traumatic growth in women with endometrial cancer.

Nonattachment Training for Post Traumatic Stress Recovery

This pilot study aims to investigate the effectiveness of a novel, co-created intervention based on principles of nonattachment for individuals recovering from Post-Traumatic Stress (PTS). Objectives include: 1. Determine whether participants undertaking nonattachment-based training have higher levels of nonattachment (as indicated by NAS Scale) after completing program. 2. Determine whether nonattachment levels are impacted after 3 months 3. Determine whether PTS symptoms are impacted by training/intervention