The purpose of the study is to examine whether 60-minute sessions of Prolonged Exposure (PE) is as effective as the standard 90-minute sessions in reducing the symptoms of posttraumatic stress disorder (PTSD). PE is a well-researched, very effective individual (one-to-one) therapy that is designed to help people to deal with traumatic events they have suffered in the past, including combat. This study is being conducted at the Charleston VA Medical Center, surrounding Community-Based Outpatient Clinics (CBOCs), and in the community. It will involve approximately 200 active duty participants. This research is funded by the Department of Defense.
This study examines the effects of the FDA-approved medication Gabapentin among individuals with Bipolar Disorder who smoke marijuana. Participants in the study will take Gabapentin and matched placebo (one at a time) for 5 days each. There are 5 study visits, including 2 MRI scans.
We recently completed an NIMH R34 in which we piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) ? a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in our pilot work. Moreover, all benchmarks for feasibility outlined in our NIMH R34 application were met or exceeded. We now propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. We will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. We will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact. The return on investment of these initiatives will ultimately rest on their potential to improve the spread of best-practice treatments and the quality with which they are delivered to the children who need them.
Many individuals who volunteer to participate in research studies are never informed about the results of those studies, and what the researchers learned from having conducted them. We believe that if researchers share results of studies with those who participated in them as volunteers, these past participants may be more likely to feel positively that they have contributed to improving the health in their communities, be more likely to enroll in other studies in the future, share their experience with others, encourage others to participate in research, and experience other positive outcomes. We want to know people's feelings about the importance of receiving study findings and how they would prefer to receive such information (what channels/formats, what kinds of messages, etc). In this study, we are looking to get the feedback of adolescents (ages 15 through 24) and older adults (50 and over) who completed their participated in an MUSC study between January 1, 2010 and present. We are also looking for MUSC researchers whose research studies have included adolescents and older adults between January 1, 2010 and the present, to get their feedback on their current strategies of sharing findings and what they believe might be best practices for doing so. Participation in our study will involve surveys and focus groups interviews.
There is an ethical obligation to provide continued intranasal esketamine treatment to subjects who participated in select Phase 3 studies and for whom the benefit versus risk has been favorable. This study provides an opportunity for subjects who have participated in the ESKETINTRD3004 study to continue to receive open label intranasal esketamine until: it is commercially available or a pre-approval access program is made available to the subject in the subject's respective country; the subject does not benefit from further treatment (based on the investigator's clinical judgment), the subject withdraws consent; or the company terminates clinical development of intranasal esketamine for Treatment Resistant Depression (TRD).
This study examines the effects of the medication gabapentin and the supplement n-acetylcysteine among individuals with Bipolar Disorder who regularly drink alcohol. Participants in this study will take gabapentin, n-acetylcysteine, and matched placebo (one at a time) for 5 days each. There are 8 study visits, including 3 MRI scans.
Recent research suggests that a new kind of treatment repetitive transcranial magnetic stimulation (rTMS) can help people with addictions quit. This study seeks to recruit individuals who are currently heavy cannabis users, who are attempting to quit using cannabis. In addition to having a 50% chance of receiving rTMS, participants will be given a behavioral treatment with known efficacy.
This study aims to conduct focus groups with adolescents and parents (30 adolescents and 30 parents) to gather feedback to help design an integrated psychological therapy for co-occurring PTSD and substance use among adolescents (Teen COPE). This information will be used to make revisions to the new Teen COPE Therapist Guide and Patient Workbook.
The purpose of this study is to understand factors contributing to managing emotions, behavior problems, and substance use risk among girls. Middle school adolescent girls will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use risk. Their reactions to recent incidents of unfair treatment or disciplinary action will also be assessed.
The purpose of this study is to understand thoughts, experiences, emotions, and behaviors of African American teens and their families. African American teens and their families will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use.