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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00539279 |
This project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder (PTSD). It will compare relaxation training (RT) to prolonged exposure therapy (PE). The project will also examine whether cognitive impairment influences psychotherapy outcome.
Primary hypotheses: (1) Subjects in the PE condition will have significantly less severe PTSD symptoms, depressive symptoms, and functional impairment than subjects in the RT condition at posttest; (2) Executive functioning will modify the response to both treatments, such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms (representing less clinically significant change).
Condition | Intervention |
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Combat Disorders Post-Traumatic Stress Disorder |
Behavioral: Prolonged Exposure Therapy (PE) Behavioral: Relaxation Training (RT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Prolonged Exposure Therapy (PE)
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Behavioral: Prolonged Exposure Therapy (PE)
PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
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2: Active Comparator
Relaxation Training (RT)
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Behavioral: Relaxation Training (RT)
RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
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PTSD is associated with high rates of mortality from suicide and health complications, high healthcare costs, and diminished health and quality of life. Many military veterans have PTSD due to combat, and many veterans continue to carry the symptoms of PTSD into late life. The percentage of older veterans is expected to increase substantially in coming years (especially as Vietnam-era veterans become older adults). The psychosocial intervention with the most rigorous empirical support for treating PTSD in the general population is a cognitive-behavioral treatment known as exposure therapy (which involves helping patients face feared memories and situations), yet there have been no controlled studies of any psychosocial interventions for PTSD in samples of older adults. Some have argued that older adults will not respond well to exposure because of their cognitive limitations. However, several empirical studies have shown exposure therapy to be safe and effective with older adults with anxiety disorders other than PTSD.
The current project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder (PTSD). It will compare relaxation training (RT) to prolonged exposure therapy (PE). The project will also examine whether cognitive impairment influences psychotherapy outcome. The five-year Research Plan is divided into three phases. Phase 1 (Year 1) involves the development of procedures for assessment and preparation for the clinical trial. Phase 2 (Years 2-4) will entail the first randomized clinical trial of psychosocial treatments for PTSD in late life. One hundred veterans aged 60 years or older, with chronic PTSD, will be recruited from the San Diego VA PTSD Clinical Team and randomly assigned to 12 sessions of PE or 12 sessions of RT. Phase 3 (Year 5) will be comprised of final data collection, scoring and interpretation of all neuropsychological tests, data cleaning and analysis, and writing for publication of results. Primary hypotheses:
(1) Subjects in the PE condition will have significantly less severe PTSD symptoms, depressive symptoms, and functional impairment than subjects in the RT condition at posttest; (2) Executive functioning will modify the response to both treatments, such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms (representing less clinically significant change).
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather Sones | (619) 680-1755 | |
Contact: Steven R Thorp, PhD | (858) 552-8585 ext 2288 | steven.thorp@va.gov |
United States, California | |
VA San Diego Healthcare System, San Diego | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Steven R Thorp, PhD 858-552-8585 ext 2288 steven.thorp@va.gov | |
Contact: Heather Sones (619) 680-1755 | |
Principal Investigator: Steven R. Thorp, PhD |
Principal Investigator: | Steven R. Thorp, PhD | VA San Diego Healthcare System, San Diego |
Responsible Party: | Department of Veterans Affairs ( Thorp, Steven - Principal Investigator ) |
Study ID Numbers: | CDA-2-009-07S |
Study First Received: | October 2, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00539279 History of Changes |
Health Authority: | United States: Federal Government |
Cognitive- Behavior Therapy Combat Disorders Elderly Geriatrics Implosive therapy |
Neuropsychological Test Post-traumatic Stress Disorder Psychotherapy Randomized Controlled Trial Relaxation techniques |
Anxiety Disorders Combat Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease Anxiety Disorders Combat Disorders |
Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |