Phase 3
N=36
Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms
Combat Disorders · Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00475241 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Clinician Administered PTSD Scale (Pre & Posttreatment) — 30.0; 53.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prolonged Exposure therapy for PTSD (Behavioral); Present centered therapy for PTSD (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (Pre & Posttreatment) |
30.0; 53.6 | — |
| SECONDARY Trauma Potentiated Startle |
4.8; 19.5 | — |
| SECONDARY Cortisol Response to Awakening |
1.2; .5 | — |
| SECONDARY Posttraumatic Cognitions Inventory |
91.3; 97.1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- OEF/OIF Veterans with combat related posttraumatic stress disorder (PTSD) or posttraumatic stress symptoms (PTSS) of at least 3 months duration with significant impairment (PSSI greater than or equal to 15).
Exclusion Criteria
- Any current level of personality disorder or suicidal risk that in the judgment of the investigator makes it unlikely or contraindicated that the patient can adhere to the study regimen.
- Psychosis
- Alcohol or substance dependence in the past 3 months
- Working night-shifts
- Changes to psychoactive medication in the past 8 weeks
- Taking medication that makes HPA axis measures difficult to interpret
Data sourced from ClinicalTrials.gov (NCT00475241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.