Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00475241 |
The goals of the proposed research are to produce preliminary evidence of PE with OEF/OIF veterans with PTSD and to examine cognitive, psychophysiological, and neuroendocrine mechanisms of change in PTSD treatment. In brief, 36 OEF/OIF 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 (i.e., PTSD, depression, and general anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., 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).
Condition | Intervention | Phase |
---|---|---|
Combat Disorders Posttraumatic Stress Disorder |
Behavioral: Prolonged Exposure therapy for PTSD Behavioral: Present centered therapy for PTSD |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms |
Estimated Enrollment: | 36 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Prolonged exposure therapy for PTSD
|
Behavioral: Prolonged Exposure therapy for PTSD
exposure-based treatment for PTSD
|
2: Active Comparator
Present centered therapy for PTSD
|
Behavioral: Present centered therapy for PTSD
present focused coping and problem solving for PTSD
|
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 OEF/OIF 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 wil 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 (i.e., PTSD, depression, and general anxiety severity), self-report of PTSD-related cognitions, psychophysiological (i.e., 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erin Defever, BA | (734) 769-7100 ext 57133 | erindef@med.umich.edu |
United States, Michigan | |
VA Ann Arbor Healthcare System | Recruiting |
Ann Arbor, Michigan, United States, 48113 | |
Contact: Erin Defever, BA 734-769-7100 ext 57133 erindef@med.umich.edu | |
Principal Investigator: Sheila Rauch, PhD |
Principal Investigator: | Sheila Rauch, PhD | VA Ann Arbor Healthcare System |
Responsible Party: | Department of Veterans Affairs ( Rauch, Sheila - Principal Investigator ) |
Study ID Numbers: | CDA-2-010-06F |
Study First Received: | May 17, 2007 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00475241 History of Changes |
Health Authority: | United States: Federal Government |
Combat Disorders Cortisol Posttraumatic Stress Disorder (PTSD) Psychophysiology |
Therapy Treatment Veterans |
Hydrocortisone Cortisol succinate Anxiety Disorders Combat Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Hydrocortisone acetate Stress Disorders, Traumatic |
Pathologic Processes Disease Anxiety Disorders Combat Disorders |
Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |