Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00475241
First received: May 17, 2007
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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) [ Time Frame: pre, mid, post, 3 and 6 mo FU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Prolonged exposure therapy for PTSD
Behavioral: Prolonged Exposure therapy for PTSD
exposure-based treatment for PTSD
Active Comparator: Arm 2
Present centered therapy for PTSD
Behavioral: Present centered therapy for PTSD
present focused coping and problem solving for PTSD

Detailed Description:

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 will 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475241

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
Investigators
Principal Investigator: Sheila Rauch, PhD VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00475241     History of Changes
Other Study ID Numbers: CDA-2-010-06F
Study First Received: May 17, 2007
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Combat Disorders
Cortisol
Posttraumatic Stress Disorder (PTSD)
Psychophysiology
Therapy
Treatment
Veterans

Additional relevant MeSH terms:
Combat Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014