Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475241
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2007-05-17
Brief Title:
Exposure Therapy for Chronic PTSD Efficacy and Mechanisms
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Exposure Therapy for Chronic PTSD Efficacy and Mechanisms
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of the proposed research are to produce preliminary evidence of PE with OEFOIF veterans with PTSD and to examine cognitive psychophysiological and neuroendocrine mechanisms of change in PTSD treatment In brief 36 OEFOIF veterans with chronic PTSD or PTSS of at least 3 months duration will be randomly assigned to 15 sessions of either PE or TAU see below for descriptions of the interventions All veterans will receive psychobiological assessments at pre treatment mid treatment post treatment 3 months and 6 months follow-up Each of these assessments will cover in 2 sessions on separate days and will include interview and self-report of symptoms ie PTSD depression and general anxiety severity self-report of PTSD-related cognitions psychophysiological ie heart rate skin conductance respiration and end-tidal CO2 assessment during neutral and trauma scripts and assessment of salivary cortisol during neutral and trauma scripts Also on the morning prior to each laboratory assessment patients will collect salivary cortisol at the moment of waking and 30 and 45 minutes post-walking In addition to these assessments patients assigned to PE will collect salivary cortisol during three imaginal exposure sessions sessions 3 9 and 15
Detailed Description:
Effective treatments for PTSD are available with exposure therapy ET programs including Prolonged Exposure PE having the most empirical evidence for effectiveness Rothbaum et al 2000 However among people receiving treatment for PTSD many are not receiving psychotherapies with empirically proven efficacy In one VA VISN only 10 of PTSD specialist therapists reported using ET routinely Rosen et al 2004 They suggested that a lack of training and human resources to provide ET as well as misconceptions about exposure therapy may drive the deficit Training efforts would be substantially more cost-effective of the proven treatments could be delivered in group formats Development and proof of efficacy of a group-based PE would provide far more veterans with access to a treatment that can truly foster recovery from the devastating impact of PTSD This is a central goal of this proposal
Little is known about the mechanisms through which PE leads to recovery Delineation of its mechanisms is a critical step towards the development of treatment refinements to improve effectiveness and efficiency of the treatment We plan to examine the potential roles of cognitive psychophysiologic and neuroendocrine factors in symptom improvement The mechanistic component will provide preliminary data on interactions between cognitive change increased sense of self-competence and control over negative outcomes psychophysiological habituation reduced reactivity to trauma related stimuli and reduced neuroendocrine sensitivity reduced hypothalamic-pituitary-adrenal HPA axis reactivity We predict that cognitive change psychophysiological habituation and reduced HPA reactivity will all be related to symptom improvement with effective treatment
Thirty-six OEFOIF veterans with chronic PTSD of at least 3 months duration will be randomly assigned to 15 weeks of twice weekly PE-G or TAU All veterans will receive psychobiological assessments at pre treatment mid treatment post treatment 3 months and 6 months follow-up Each of these assessments will include interview and self-report of symptoms ie PTSD depression and general anxiety severity self-report of PTSD-related cognitions psychophysiological ie heart rate skin conductance respiration and end-tidal CO2 assessment during neutral and trauma scripts and assessment of salivary cortisol during neutral and trauma scripts Also on the morning prior to each laboratory assessment patients will collect salivary cortisol at the moment of waking and 30 and 45 minutes post-walking The results from this study will be used as pilot data for VA Merit Award and NIMH R01 applications for larger follow-up studies
Little is known about the mechanisms through which PE leads to recovery Delineation of its mechanisms is a critical step towards the development of treatment refinements to improve effectiveness and efficiency of the treatment We plan to examine the potential roles of cognitive psychophysiologic and neuroendocrine factors in symptom improvement The mechanistic component will provide preliminary data on interactions between cognitive change increased sense of self-competence and control over negative outcomes psychophysiological habituation reduced reactivity to trauma related stimuli and reduced neuroendocrine sensitivity reduced hypothalamic-pituitary-adrenal HPA axis reactivity We predict that cognitive change psychophysiological habituation and reduced HPA reactivity will all be related to symptom improvement with effective treatment
Thirty-six OEFOIF veterans with chronic PTSD of at least 3 months duration will be randomly assigned to 15 weeks of twice weekly PE-G or TAU All veterans will receive psychobiological assessments at pre treatment mid treatment post treatment 3 months and 6 months follow-up Each of these assessments will include interview and self-report of symptoms ie PTSD depression and general anxiety severity self-report of PTSD-related cognitions psychophysiological ie heart rate skin conductance respiration and end-tidal CO2 assessment during neutral and trauma scripts and assessment of salivary cortisol during neutral and trauma scripts Also on the morning prior to each laboratory assessment patients will collect salivary cortisol at the moment of waking and 30 and 45 minutes post-walking The results from this study will be used as pilot data for VA Merit Award and NIMH R01 applications for larger follow-up studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None