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Clinical Trials: Psychiatry - General Adult/Mental Health (Depression, Anxiety, Etc.)
IRB No. 14-049-1 (Dr. Jayesh Kamath, PI): Investigation of antipsychotic medication related cardiometabolic risk factors in patients with psychotic vs non-psychotic disorders in comparison with a control group
Use of atypical antipsychotics has been on the rise secondary to increasing on and off label use of these medications in patients with psychiatric illness. Antipsychotics use has been associated with weight gain and changes in metabolic parameters such as fasting blood glucose, cholesterol and triglycerides leading to the development of metabolic syndrome [1,2]. These in turn contribute to development of diabetes and increased cardiovascular risks [1]. Antipsychotic use is independently associated with cardiometabolic risks, even after adjusting for patient’s lifestyles characteristics [3]. While antipsychotics have limited FDA indications (schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder and treatment of irritability associated with autistic disorder) there has been a significant rise in prescription of antipsychotics for off-label diagnoses for the past few years. This is especially true for atypical antipsychotics that have been used for variety of disorders including obsessive compulsive disorder (OCD), combat-related post-traumatic stress disorder (PTSD), generalized anxiety disorder and behavioral management of dementia patients [1,4]. Monitoring of metabolic parameters including body weight, glycaemia and dyslipidemia has been a standard care for patients with schizophrenia. However, clinicians might not adhere to the monitoring guidelines when antipsychotics are used for non-psychotic indications. Preliminary data collected in our clinic suggest that there are significant gaps in monitoring of cardiovascular and metabolic factors in patients receiving antipsychotics for non-psychotic indications [5].
IRB No. 14-141-6 (Dr. Jayesh Kamath, PI): A Text Messaging Intervention to Improve Psychiatric Treatment Adherence: A Proof-of-Principle Study
Lack of adherence to psychiatric treatment is prevalent and problematic. Between 1/3 to 1/2 of patients on psychotropic medications are not adherent to prescription regimes and about 50% of psychiatric services appointments are no-shows. Low treatment adherence is associated with greater risk of emergency department use and hospitalization. It’s been estimated that antipsychotic non-adherence alone is responsible for about $1.5 billion in annual hospital costs in the US. Among reasons for non-adherence identified in the literature, forgetting is most commonly cited. Other factors include perceived social support, perceived therapeutic alliance, younger age, male gender, and ethnic minority background. Low cost interventions are needed to increase psychiatric treatment adherence that are responsive to known reasons for low adherence. A growing body of research demonstrates improvements in treatment adherence and clinical outcomes associated with similar text messaging interventions; however few studies have been conducted with psychiatric patients. Given the potential for improvements in health and cost savings, the proposed pilot study holds great promise for reward. We view the proposed work as an important first step leading to larger external funding and forming the core of a research collaboration that we hope to expand, particularly for the justice-involved. We have identified multiple opportunities for growing the research project within UConn and throughout the community.
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. 15-070-3 (Dr. Jayesh Kamath, PI): Antipsychotic Medications and Sexual Dysfunction
The proposed cross-sectional study is to investigate antipsychotic medication induced sexual dysfunctions in adult male patients using comprehensive, validated sexual function questionnaires, to evaluate relationship between dose equivalence of antipsychotic medications, treatment of emergent sexual dysfunctions, and endocrine changes.
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. 15-164S-3 (Dr. Julie Wagner, PI): Diabetes Risk Reduction through Eat,Walk,Sleep And Medication Therapy Management for Depressed Cambodians (DREAM)
Diabetes Risk Reduction through Eat, Walk, Sleep And Medication Therapy Management for Depressed Cambodians (DREAM) This project is designed to reduce risk for diabetes in Cambodian Americans with depression. 210 Cambodian Americans in southern New England will be screened for their diabetes risk as well as depression; those at risk for diabetes with depression will be enrolled. This study will determine the effect of Lifestyle Modification vs Lifestyle + Medication Therapy Management (MTM) vs Supportive Services Control. Assessments gather data such as sleep, activity, anthropometrics, mental health symptoms, and medications at baseline, 1year and 2years. Blood tests will be performed on the same schedule for glucose, insulin, and inflammation. Hair samples will be obtained on the same schedule for levels of cortisol Cambodian Americans have been previously studied by these Investigators who found that found 50% of this group (over age 35) have 5 or more chronic diseases including heart attack, chronic depression and/ or PTSD. Their rates of diseases like diabetes, hypertension and high cholesterol are twice those of national averages. Overall Cambodian health status in the US is worse than other Asian refugee groups resettled in the US from their refugee camps. The Diabetes Prevention Program (DPP) has shown that disease onset can be delayed or even prevented by lifestyle modification programs such as that to be provided here. The KHA agency is a partner with the National Diabetes Education Program and committed to overcoming care barriers which underserved communities face. Such programs help mitigate depression by activating and engaging their clients. This PI & Team will utilize Community Health Workers (CHW) to conduct the research and deliver the lifestyle program called Eat, Walk, Sleep. 1/3 of the subjects will receive EWS which has been specifically tailored for the unique language and cultural considerations in this group.The PI has previously done a similar diabetes education intervention with non english speaking Latinos with low literacy- delivered in an ethnic agency setting by CHWs, including home and group participation. For 1/3, EWS is combined with secure pharmacist (Medication Therapy Management-MTM) videoconferencing interactions at home. 1/3 (70 subjects) 1/3 will receive control/Supportive Services Group- will receive Enhanced Standard CHW support/services referral, while undergoing the same initial evaluation assessments . The researchers seek to determine that lifestyle intervention will produce greater improvement in risk factiors and that biologic factors-waist size,blood pressure, diabetes marker- HgBA1c, and others are improved.
IRB No. 16-098-1 (Dr. Jayesh Kamath, PI): A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment. Family Intervention in Recent onset Schizophrenia Treatment (FIRST)
Family education and training has been shown to have a positive impact on both the individual with psychosis and their caregivers when it is embedded within a treatment program. Providing support to caregivers to help make them be more active and effective participants in the patient's recovery can be a cost-effective approach that contributes to better patient outcomes. This study will enroll patients recently diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder that are prescribed either paliperidone palmitate or oral antipsychotic treatment, and their designated caregivers. Outcomes in patients with caregivers receiving a study-provided psycho-education and skills training program will be compared to patients with caregivers receiving usual caregiver support (caregiver support that is customarily provided by the study site, if any). OBJECTIVE AND HYPOTHESES Primary Objective: To evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric ER visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period. Primary Hypothesis: When caregivers receive a study-provided psycho-education and skills training, patients with schizophrenia, schizoaffective disorder, and schizophreniform disorder under their care will have fewer treatment failures compared with patients whose caregivers receive usual caregiver support. Secondary Hypotheses: Over a 12 month period study-provided caregiver psycho-education and skills training will be superior to usual caregiver support in reducing caregiver burden and distress. Patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder receiving oral antipsychotic treatment and who have caregivers receiving a study-provided caregiver psycho-education and skills training program will have fewer treatment failures compared with patients receiving oral antipsychotic treatment that have caregivers receiving usual caregiver support. Patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder receiving paliperidone palmitate treatment and who have caregivers receiving study-provided caregiver psycho-education and skills training program will have fewer treatment failures compared with patients receiving paliperidone palmitate that have caregivers receiving usual caregiver support.