Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms
1 other identifier
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
November 10, 2014
CompletedFebruary 15, 2019
February 1, 2019
2.5 years
May 17, 2007
October 27, 2014
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale (Pre & Posttreatment)
Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.
PostTreatment (Week 12)
Secondary Outcomes (3)
Trauma Potentiated Startle
PostTreatment (Week 12)
Cortisol Response to Awakening
PostTreatment (Week 12)
Posttraumatic Cognitions Inventory
PostTreatment (Week 12)
Study Arms (2)
Prolonged Exposure Therapy
EXPERIMENTALProlonged exposure therapy for PTSD
Present Centered Therapy
ACTIVE COMPARATORPresent centered therapy for PTSD
Interventions
exposure-based treatment for PTSD
present focused coping and problem solving for PTSD
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113, United States
Related Publications (3)
Sripada RK, Rauch SA, Tuerk PW, Smith E, Defever AM, Mayer RA, Messina M, Venners M. Mild traumatic brain injury and treatment response in prolonged exposure for PTSD. J Trauma Stress. 2013 Jun;26(3):369-75. doi: 10.1002/jts.21813. Epub 2013 May 20.
PMID: 23696427RESULTSivakumar RK, Samy W, Pakpirom J, Songthamwat B, Karmakar MK. Ultrasound-guided selective trunk block: Evaluation of ipsilateral sensorimotor block dynamics, hemidiaphragmatic function and efficacy for upper extremity surgery. A single-centre cohort study. Eur J Anaesthesiol. 2022 Oct 1;39(10):801-809. doi: 10.1097/EJA.0000000000001736. Epub 2022 Aug 11.
PMID: 35950709DERIVEDRauch SAM, King AP, Liberzon I, Sripada RK. Changes in Salivary Cortisol During Psychotherapy for Posttraumatic Stress Disorder: A Pilot Study in 30 Veterans. J Clin Psychiatry. 2017 May;78(5):599-603. doi: 10.4088/JCP.15m10596.
PMID: 28102979DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheila A.M. Rauch
- Organization
- VA Ann Arbor Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Sheila Rauch, PhD
VA Ann Arbor Healthcare System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinded Assessors
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
January 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 15, 2019
Results First Posted
November 10, 2014
Record last verified: 2019-02