13 Clinical Trials for Various Conditions
NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.
Conduct a randomized trial (n = 60: with n = 30 receiving music therapy and n = 30 receiving usual care) to investigate the feasibility, acceptability, and preliminary efficacy of the MAJOR CHORD music therapy intervention compared to usual care on (a) health-related quality of life (e.g., physical function, depression, anxiety, fatigue, and pain interference), (b) perceived stress, (c) self-efficacy, and (d) 30-day readmission rates
Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Therapists will deliver the treatment in real time over the Internet and/or by telephone to increase treatment access. This planning grant seeks support for a two-site study (North Carolina and California) that consists of two phases. In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and RCBT. In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions. The purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. The importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. If 65% of Americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.
The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to use a strategy for delaying and reducing cigarette use.
This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.
The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to: * Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration * Characterize the immunogenicity of casirivimab and imdevimab in serum over time
The primary objectives are: * To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: * To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo * To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration * To assess the immunogenicity of REGN10933 and REGN10987
The purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in VA work services.
Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery. This project will define the interactions between the stress, chronic inflammation, bone marrow dysfunction, and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma.
The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.
Persons with serious mental illness are at increased risk of cardiovascular disease. The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and to get feedback from patients and providers on what is needed to help better coordinate and physical and mental health care of these patients.
The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce health care utilization. Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years. Outcomes will be measured at three points: at entry, at the end of the 6 month intervention, and 12 months after entry. Change in functional capacity at the end of the intervention program is the primary outcome.
Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.