2007 — 2009 |
Galovski, Tara E |
R34Activity Code Description: To provide support for the initial development of a clinical trial or research project, including the establishment of the research team; the development of tools for data management and oversight of the research; the development of a trial design or experimental research designs and other essential elements of the study or project, such as the protocol, recruitment strategies, procedure manuals and collection of feasibility data. |
Improving Effectiveness: Treatment Outcome Research @ University of Missouri-St. Louis
[unreadable] DESCRIPTION (provided by applicant): This application seeks to increase the effectiveness of an existing treatment strategy, cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder among crime victims by varying the duration and content of the intervention in accordance with participants' needs. A secondary goal is to identify predictors of duration of treatment necessary to achieve good end state functioning, including individual and trauma variables, cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of male participants, the generalizability of CPT will be tested. It is anticipated that these modifications will speed the dissemination of CPT to community practice thus benefiting more trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition or to a symptom-monitoring, minimal attention condition designed to control for the effects of the daily monitoring and the passage of time. Utilizing a semicrossover design, the control condition will be crossed over to the active treatment, allowing for a replication within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50) receiving strict 12- session protocol-driven CPT through the course of a recent study conducted at the same site using the same primary outcome measures. Participants in the study will be administered a battery of interviews and self-report measures which include 1.) Clinician Administered PTSD Scale, 2.) Structured Clinical Interview for DSM-IV Axis I & II Disorders, 3.) Standardized Trauma Interview, 4.) PTSD Diagnostic Scale, 5.) Beck Depression Inventory - II, 6.) Trauma-Related Guilt Inventory, 7.) Pennebaker Inventory of Limbic Languidness. Subjects will monitor progress through use of daily diaries as well as undergo formal assessments at pre-treatment, at three status checkpoints during therapy, at post-treatment, and at a three month follow-up point. Conducting the proposed study will have important implications on advancing the ecological validity and effectiveness of applied research on PTSD. [unreadable] [unreadable] [unreadable]
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0.993 |
2008 — 2010 |
Galovski, Tara E |
R21Activity Code Description: To encourage the development of new research activities in categorical program areas. (Support generally is restricted in level of support and in time.) |
Sleep-Directed Hypnosis as a Complement to Cpt in Treating Ptsd @ University of Missouri-St. Louis
[unreadable] DESCRIPTION (provided by applicant): This proposal seeks to test the efficacy of sleep-directed hypnosis as a complement to an existing empirically supported psychosocial intervention, Cognitive Processing Therapy (CPT) in sample of survivors of interpersonal violence suffering from PTSD. Further, this proposal seeks to identify mechanisms of action in the therapy that lead to symptom modification, improvement in larger domains of functioning, and health-related concerns. Towards this end, a multi-method, multimodal assessment will be administered including daily and intermittent monitoring across psychiatric, psychological, and psychophysiological domains. Specifically, forty subjects will be randomly assigned to either a hypnosis + CPT (hypCPT) condition or to a symptom monitoring, delayed treatment group (SMDT) designed to control for the effects of monitoring, the passage of time, and as a means to assess the basic temporal relationship between sleep, PTSD symptoms and daily stress. Utilizing a semicrossover design, the control condition will be crossed over to the active treatment, allowing for a replication within the study. The entire treated sample (N = 40) will be compared to a sample (N = 50) of similar trauma survivors who have recently been treated with a strict CPT only, manualized therapy through the course of a recently concluded NIH-funded large scale clinical trial conducted at the same site and using the same measures. Participants in this study will be administered a battery of interviews and self-report measures including the 1.) Clinician Administered PTSD Scale, 2.) Structured Clinical Interview for DSM-IV Axis I Disorders, 3.) Standardized Trauma Interview, 4.) PTSD Diagnostic Scale, 5) Beck Depression Inventory - II, 6.) Pennebaker Inventory of Limbic Landuigness, 7.) The SF-36 Health Survey, 8.) Quality of Life Inventory, 9.) Social Adjustment Scale, 10) Pittsburgh Sleep Quality Index, and the 11) Insomnia Severity Index. In addition, physiological indices will be used to assess the relationship between sleep impairment and hyperarousal as well as changes over time in physiological reactivity. A Psychomotor Vigilance Task will also be administered to test for the presence of sleep deprivation (i.e. "sleepiness" as measured by reaction time) as well as related changes over time. Subjects will monitor symptoms and daily stressors through the use of daily diaries as well as undergo formal assessments at pre-treatment, post- treatment and three month follow-up points. Conducting the proposed study will have important implications on remediating sleep impairment (the most often reported symptom of PTSD and one of the most refractory to treatment) utilizing a novel approach, the addition of hypnosis, within a traumatized population. Concurrently this proposal aims to illuminate the mechanisms of action in hypnosis, an understudied complementary treatment element with virtually no empirical support in the trauma literature. [unreadable] Public Health Relevance: Posttraumatic Stress Disorder (PTSD) is commonly considered to be chronic and enduring in presentation and is typically associated with debilitating impairment across multiple domains of functioning with a resultant high level of societal cost (Kessler, 2000) Sleep impairment is identified as an early predictor of the development of PTSD (Koren, et al, 2002), is the most often reported of the 17 PTSD symptoms (Green, 1993), is considered one of the most refractory to treatment (Krakow, Hollifield, et al, 2001; Cooper and Clum, 1989; Zayfert and DeViva, 2004), and is identified as a mediator between PTSD symptoms and somatization and functional disability (Clum, Nishith, & Resick, 2001; Mellman et al, 1995; Mohr et al., 2003). Thus the specific remediation of sleep impairment within a trauma population could result in substantial decreases in overall PTSD symptomatology which would then result in reduced psychosocial impairment, health-related concerns, and societal expense. [unreadable] [unreadable] [unreadable]
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0.993 |