| October 2, 2007 |
| October 22, 2009 |
| March 2009 |
| January 2013 (final data collection date for primary outcome measure) |
| PTSD symptoms (CAPS; PTSD Checklist), depressive symptoms (PHQ-9), and functional impairment (SF-36; Sheehan Disability Scale) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ] |
| PTSD symptoms (PTSD Checklist), depressive symptoms (BDI-II), and functional impairment (Sheehan Disability Scale) will be assessed at pre-treatment, post-treatment, and 6-month follow-up points. |
| Complete list of historical versions of study NCT00539279 on ClinicalTrials.gov Archive Site |
- Wechsler Test of Adult Reading and 7 brief tests of executive functioning: Trail Making, Verbal Fluency, & Color-World Interference, Digit Span, Rey-Osterrieth Complex Figure Test, CA Verbal Learning Test-II, WI Card Sort Test [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
- Pittsburgh Sleep Quality Index [ Time Frame: Pre-treatment; post-treatment ] [ Designated as safety issue: No ]
- Insomnia Severity Index [ Time Frame: Pre-treatment; post-treatment ] [ Designated as safety issue: No ]
- Posttraumatic Cognitions Inventory [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
- Posttraumatic Growth Inventory [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
- Treatment Preferences and Satisfaction [ Time Frame: Session 3 and Session 12 ] [ Designated as safety issue: No ]
- State-Trait Anxiety [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
- Mindfulness [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
|
| 6-month follow-up: Wechsler Test of Adult Reading and 7 brief tests of executive functioning: Trail Making, Verbal Fluency, & Color-World Interference, Digit Span, Rey-Osterrieth Complex Figure Test, CA Verbal Learning Test-II, WI Card Sort Test |
| |
| Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder |
| Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder |
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). |
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). |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Combat Disorders
- Post-Traumatic Stress Disorder
|
- Behavioral: Prolonged Exposure Therapy (PE)
- Behavioral: Relaxation Training (RT)
|
- Experimental: Prolonged Exposure Therapy (PE)
- Active Comparator: Relaxation Training (RT)
|
| |
| |
| Recruiting |
| 100 |
| March 2013 |
| January 2013 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Veterans with primary diagnosis of chronic PTSD due to combat or non-sexual military trauma; comorbid mood and anxiety disorders are expected, and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms
- Male
- Age 60 or older; and
- English literacy.
Exclusion Criteria:
- Unmanaged psychosis or manic episodes in past year
- Substance abuse or alcohol dependence in past year
- Concurrent psychotherapies targeting PTSD or exposure therapy for other anxiety symptoms [veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs for substance problems) will be eligible]
- Severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions
- Probable dementia (based on chart diagnosis); or
- Head trauma resulting in loss of consciousness longer than 20 minutes.
|
| Male |
| 60 Years and older |
| No |
| Contact: Heather Sones |
(619) 680-1755 |
|
|
| Contact: Steven R Thorp, PhD |
(858) 552-8585 ext 2288 |
steven.thorp@va.gov |
|
|
| United States |
| |
| NCT00539279 |
| Thorp, Steven - Principal Investigator, Department of Veterans Affairs |
| CDA-2-009-07S |
| Department of Veterans Affairs |
|
| Principal Investigator: |
Steven R. Thorp, PhD |
VA San Diego Healthcare System, San Diego |
|
|
| Department of Veterans Affairs |
| October 2009 |