Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

Completed · Phase 2/Phase 3

Conditions studied: Combat Disorders, Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT00475241

Run by

VA Office of Research and Development

People needed

36

Starts

2008-01-01

Expected to finish

2010-07-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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