5 Clinical Trials for Various Conditions
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.
The purpose of this randomized controlled clinical trial with first-generation college students with symptoms of mental illness is to test the preliminary feasibility and efficacy of TIPSTART, a multi-faceted, mental health and exercise training program-involving 5.5 hours of training delivered via assistance of remote technology, a licensed therapist and certified exercise behavior change specialist, and supported by peer pods-relative to a group receiving usual care. Students will confirm they are not currently treated with medication but have received mental health services in the past two years, and meet symptom cutoff criteria using a standard field screening assessment. It is hypothesized that the 10-week training program initiated at the onset of an academic semester will improve students' symptoms of anxiety and depression. Further, it is also expected that greater physical activity, self-efficacy, and social and academic engagement among participants in the TIPSTART group as compared to the usual care condition. Finally, the potential role of TIPSTART in changes in resilience, self-regulatory functioning and schoolwork-life balance will be explored.
The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus. For this study, participants will be randomized into either the Telehealth Program or the standard of care group. The personal health planning (PHP) Type 2 Diabetes program is a virtual, 8 session/16- week behavioral health program. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, on-demand video sessions; lessons, discussions, and activities based on understanding behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices; 3 and 6-month post program sessions and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Those in the control group will receive usual care by the participants personal care team. All participants will come to the Duke Research at Pickett Road facility for a pre and post-program fasting A1C and lipid panel blood draw (if required).
The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads (VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group clinical visits for seven weeks plus social media website) or appointment with an adherence counselor (a minimum of 3 visits) (control condition). Data sources will include interviews, medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at the completion of the intervention assessed via pill count. The secondary outcome will be HIV VL suppression.
This study employs a Sequential Multiple Assignment Randomized Trial (SMART) and aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity and improve cardiovascular health among sedentary employed women.