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Clinical Trials: Psychiatry - General Adult/Mental Health (Depression, Anxiety, Etc.)
IRB No. 14-181-1 (Dr. Jayesh Kamath, PI): Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
This research study will be looking at treatment for post-traumatic stress disorder (PTSD) resulting from experiencing interpersonal violence. The researchers hope to learn whether a flexibly applied cognitive behavioral treatment for PTSD called Skills Training in Affective and Interpersonal Regulation / Narrative Therapy (STAIR/NT) is more effective than the psychotherapy usually provided in the clinic, which is called Treatment as Usual or TAU. STAIR/NT Cognitive-behavior therapy. The cognitive-behavioral therapy used in this study has been shown to be helpful for people with PTSD and other problems which resulted from interpersonal trauma. It works with people's emotions and thoughts related to trauma and helps them create more effective ways of living and interacting with others. We have evidence suggesting that flexible application of the treatment provides the same benefits as a strict order of sessions. Subjects assigned to cognitive-behavioral therapy, subjects and therapists will work together to make decisions about how to use the cognitive-behavioral treatment. The treatment can have as few as 16 sessions and as many as 24 sessions. The sessions will be scheduled once a week and will last 45 minutes. In collaboration with the therapist, subjects can choose to repeat specific activities from a session or to skip them, depending on whether they and the therapist think that these activities will be helpful. There are some basic minimum requirements in the use of the therapy. The first is that the subject complete the activities of the treatment in the following order and have the following minimum number of sessions specific to three types of sessions. Specifically, the treatment requires (1) three sessions of skills training in emotion management, (2) four sessions of social skills training and (3) five sessions which involve the discussion of the trauma and specific thoughts and beliefs related to the trauma. Treatment As Usual. Subjects randomized to Treatment As Usual (TAU), will receive the treatment that the clinic routinely gives to clients. The treatment will occur weekly. The duration of the treatment will depend on how decisions about treatment length are usually decided at the clinic. The treatment will last no longer than the 12 months of the study. Regardless of the treatment subjects receive, they will be asked to give a complete psychiatric and medical history and may be asked to obtain records of medical and psychiatric history.
IRB No. 15-157-6 (Dr. Golda Ginsburg, PI): Unified Treatment of Emotional Disorders in Community Clinics
Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. Evidence-based therapies (EBTs) exist for single disorders (e.g., depression) or small clusters of disorders (e.g., anxiety disorders) but such EBTs are rarely integrated in community mental health clinic (CMHC) settings and effect sizes are modest (40-50% of youth are treatment non-responders). Thus, methods for improving outcomes for these youth, particularly in CMHCs, are needed. Transdiagnostic treatment, such as the Unified Protocols for the Treatment of Emotional Disorders in adults (UP), adolescents (UP-A) and children (UP-C) is a promising new approach that uses a small number of common strategies to treat these conditions. Another novel approach to improving clinical outcomes for youth with emotional disorders in CMHCs is the incorporation of a standardized measurement and feedback system (MFS). Emerging data suggests that MFS alone improves outcomes relative to treatment as usual (TAU) but this has not been adequately tested in youth. Thus, our first aim is to examine the effectiveness of UP-A and a MFS relative to TAU, when delivered in CMHCs. A serious shortcoming of RCTs comparing EBTs to TAU is the confounding effects of increased measurement and feedback to clinicians as RCTs of EBTs often “build in” monitoring that is not part of standard care. This raises the possibility that increased monitoring, rather than the unique treatment components of the EBT, may be responsible for better outcomes over TAU. Thus, the second aim of this proposal is to isolate these effects from UP-A. Finally, this study will examine theoretically-linked mechanisms (both patient and provider level) of treatment outcomes of both the UP-A and the Youth Outcomes Questionnaire (YOQ). This project is an NIMH-funded collaborative R01 two -site trial (UM grant PIs Jill Ehrenreich-May and Amanda Jensen-Doss; University of Connecticut PI Golda Ginsburg - for IRB purposes, the UM PI will be Amanda Jensen-Doss). To address the three study aims, adolescents with anxiety and/or depressive disorders will be recruited from CMHCs in Miami and in CT (under the supervision of Dr. Golda Ginsburg at the University of Connecticut). Both adolescents and clinicians will be randomized to one of three conditions: (1) TAU alone; (2) TAU plus YOQ (TAU+); and (3) UP-A plus YOQ (UP-A). Research assessments by Independent Evaluators (IEs), children, parents, and clinicians will occur at baseline, 8 weeks and 16 weeks after treatment initiation and a 3-month follow-up. The primary aims of this study are as follows: Aim 1: To examine the effectiveness of UP-A and YOQ compared to TAU. Aim 1 will test whether adolescents treated with UP-A and YOQ (plus TAU referred to as TAU +) demonstrate better response than those receiving TAU alone. Hypothesis 1: A higher percent of adolescents treated with UP-A and TAU +, compared to TAU, will be treatment responders at 16 weeks after treatment initiation and at follow-up. Aim 2: To isolate the effects of evidenced-based measurement and feedback. Aim 2 will examine the relative effectiveness of the UP-A condition to the TAU+ condition. Hypothesis 2: A higher percent of UP-A participants will be treatment responders than TAU+ participants at the 16 week and follow up assessments. Aim 3: To examine mechanisms theoretically associated with UP-A and YOQ. Hypothesis 3a: Differences in outcomes between the UP-A and the other two conditions will be mediated by changes in: Emotional Reactivity and Regulation (Using the Reactivity and Regulation-Images Task, REAR-I) and Behavioral Avoidance (using the Avoidance Hierarchy).
IRB No. 16-055-2 (Dr. David Steffens, PI): Department of Psychiatry: Adult Repository
The purpose of the repository is to prospectively collect biological samples along with clinical data to facilitate future research studies and pilot analysis related to medical and behavioral health research.
IRB No. 19-136-2 (Dr. Riddhi Doshi, PI): Video Directly Observed Therapy (VDOT) to Improve Medication Adherence among Depression Patients
Depression is a major public health concern in the United States affecting over 16 million adult Americans. A majority of patients diagnosed with depression receive medication with or without psychotherapy. According to the current clinical guidelines, the recommended treatment of major depression lasts atleast six months. Research evidence demonstrates that patient adherence to antidepressants is poor. There are a number of reasons reported for medication non-adherence including patient demographics, other patient-related factors (forgetfulness, attitude), and illness related factors (comorbidities). Meta-analysis of pooled data from 16 randomized controlled trials revealed that mobile text messaging resulted in 68% improvement in medication adherence among patients with chronic diseases. However, text-based interventions rely on patient reported adherence, which are prone to reporting bias. Due to lack of human resources, it is impossible to monitor patients' medication adherence objectively or in-person by observation like tuberculosis programs worldwide do. The feasibility and patient acceptance of the innovative video-based directly observed therapy (VDOT) approach for improving medication adherence among tuberculosis patients has been demonstrated through studies in the United States as well as internationally. Medication adherence among VDOT users has been found to be comparable to in-person directly observed treatment (91% vs 95%) among patients in New York. In this clinical research project, I will test the feasibility, acceptance and effectiveness of an innovative mobile-based behavioral intervention to improve medication adherence and depression symptoms among patients suffering from depression. This low-cost, resource-saving approach can be generalized to other mental health conditions. Hypothesis a)VDOT technology is acceptable to depression patients; b) Depression patients receiving VDOT have significantly higher medication adherence rates compared to control patients; c) Depression patients receiving VDOT have significantly higher improvement in depression symptoms compared to control patients. Specific aims Aim 1: To determine the technology acceptance (ease of use, usefulness, subjective norm) of VDOT, and identify factors associated with differences in acceptance among patients diagnosed with depression; Aim 2: To compare the effectiveness of VDOT vs standard of care in improving medication adherence; Aim 3: To compare the effectiveness of VDOT vs standard of care in improving depression symptoms.