N/A
N=87
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Combat Disorders · Post-traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00539279 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: PTSD Checklist (PCL) — 57.46; 59.98; 47.00; 58.06 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prolonged Exposure Therapy (PE) (Behavioral); Relaxation Training (RT) (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Male
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Checklist (PCL) |
57.46; 59.98; 47.00; 58.06; 58.37; 58.31 | — |
| PRIMARY Patient Health Questionnaire Depression Subscale (PHQ-9) |
12.13; 15.12; 10.88; 14.80; 13.12; 13.92 | — |
| PRIMARY Clinician-Administered PTSD Scale Severity Score (CAPS) |
66.02; 72.98; 48.48; 64.45; 29.16; 37.40 | — |
| SECONDARY Posttraumatic Cognitions Inventory (PTCI) |
3.14; 3.78; 2.80; 3.72; 3.44; 3.84 | — |
| SECONDARY State-Trait Anxiety Inventory State Scale (STAI-S) |
44.46; 41.67; 42.64; 43.75; 43.72; 42.63 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
18.15; 18.83; 15.31; 18.77; 21.06; 17.71 | — |
| SECONDARY Global Neuropsychological Deficits (Standardized, Composite) |
.32; .42; .35; .40 | — |
Summary
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).
Eligibility Criteria
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 dependence or alcohol dependence in past 3 months
- 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.
Data sourced from ClinicalTrials.gov (NCT00539279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.