Post-traumatic Stress Disorder Clinical Trial
Official title:
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Verified date | August 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 87 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 60 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD Checklist (PCL) | The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms. | Pre-treatment, post-treatment, and 6-month follow-up | No |
Primary | Patient Health Questionnaire Depression Subscale (PHQ-9) | The PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows: 0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression |
Pre-treatment, post-treatment, and 6-month follow-up | No |
Primary | Clinician-Administered PTSD Scale Severity Score (CAPS) | The CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes. | Pre-treatment, post-treatment, and 6-month follow-up | No |
Secondary | Posttraumatic Cognitions Inventory (PTCI) | The PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions. | Pre-treatment, post-treatment, and 6-month follow-up | No |
Secondary | State-Trait Anxiety Inventory State Scale (STAI-S) | The STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., "I feel calm") are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety. | Pre-treatment, post-treatment, and 6-month follow-up | No |
Secondary | Sheehan Disability Scale (SDS) | The SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning. | Pre-treatment, post-treatment, and 6-month follow-up | No |
Secondary | Global Neuropsychological Deficits (Standardized, Composite) | Among our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: >40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; < 20 = 5. Higher scores mean a higher global cognitive deficit. | Pre-treatment, post-treatment | No |
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