Clinical Trial: Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

Brief Summary: 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).

Detailed Summary:

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 durati
Sponsor: VA Office of Research and Development

Current Primary Outcome: Clinician Administered PTSD Scale (Pre & Posttreatment) [ Time Frame: PostTreatment (Week 12) ]

Clinician Adminstered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.


Original Primary Outcome:

  • PTSD Symptom Severity (pre, mis, posttreatment, 3 and 6 month follow-up)- PTSD Symptom Scale-Interview (PSS-I; Foa et al., 1993)- Posttraumatic Stress Diagnostic Scale (PDS; self-report; Foa et al., 1997)
  • Psychophysiological reactivity will be assessed using a Biopac MP-100 physiology recording system for measurement of heart rate (electrocardiography, ECG), skin conductance, respiration, and end-tidal pCO2 (pre, mid, posttreatment, 3 and 6 mo FU).
  • HPA axis reactivity will be assessed with collection of salivary cortisol at each major assessment. Cortisol response to awakening, our measure of general stress reactivity, will be calculated.


Current Secondary Outcome:

  • Psychophysiological Reactivity Will be Assessed Using a Biopac MP-100 Physiology Recording System for Measurement of Heart Rate (Electrocardiography, ECG), Skin Conductance, Respiration, and End-tidal pCO2 (Pre, Mid, Posttreatment, 3 and 6 mo FU). [ Time Frame: pre, mid, post, 3 and 6 mo FU ]
  • HPA Axis Reactivity Will be Assessed With Collection of Salivary Cortisol at Each Major Assessment. Cortisol Response to Awakening, Our Measure of General Stress Reactivity, Will be Calculated. [ Time Frame: pre, mid, post, 3 and 6 mo FU ]
  • All of Below Measures Are Taken at the Major Assessment Points.- Beck Depression Inventory-II- Depression Anxiety Stress Scale- Posttraumatic Cognitions Inventory- Client Satisfaction Questionnaire [ Time Frame: pre, mid, post, 3 and 6 mo FU ]


Original Secondary Outcome: All of below measures are taken at the major assessment points. - Beck Depression Inventory-II - Depression Anxiety Stress Scale - Posttraumatic Cognitions Inventory - Client Satisfaction Questionnaire

Information By: VA Office of Research and Development

Dates:
Date Received: May 17, 2007
Date Started: January 2008
Date Completion:
Last Updated: November 3, 2014
Last Verified: November 2014