Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
1 other identifier
interventional
87
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
August 19, 2015
CompletedAugust 19, 2015
August 1, 2015
4 years
October 2, 2007
April 29, 2015
August 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Secondary Outcomes (4)
Posttraumatic Cognitions Inventory (PTCI)
Pre-treatment, post-treatment, and 6-month follow-up
State-Trait Anxiety Inventory State Scale (STAI-S)
Pre-treatment, post-treatment, and 6-month follow-up
Sheehan Disability Scale (SDS)
Pre-treatment, post-treatment, and 6-month follow-up
Global Neuropsychological Deficits (Standardized, Composite)
Pre-treatment, post-treatment
Study Arms (2)
Prolonged Exposure Therapy (PE)
EXPERIMENTALProlonged Exposure Therapy (PE)
Relaxation Training (RT)
ACTIVE COMPARATORRelaxation Training (RT)
Interventions
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).
RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
Related Publications (2)
Walter KH, Glassman LH, Wells SY, Thorp SR, Morland LA. The Impact of Depression Severity on Treatment Outcomes Among Older Male Combat Veterans with Posttraumatic Stress Disorder. J Trauma Stress. 2020 Jun;33(3):345-352. doi: 10.1002/jts.22503. Epub 2020 Mar 26.
PMID: 32216149DERIVEDThorp SR, Glassman LH, Wells SY, Walter KH, Gebhardt H, Twamley E, Golshan S, Pittman J, Penski K, Allard C, Morland LA, Wetherell J. A randomized controlled trial of prolonged exposure therapy versus relaxation training for older veterans with military-related PTSD. J Anxiety Disord. 2019 May;64:45-54. doi: 10.1016/j.janxdis.2019.02.003. Epub 2019 Feb 21.
PMID: 30978622DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to smaller numbers of subjects analyzed at post-treatment and follow-up; Results generalize only to older male combat veterans who were treatment-seeking for PTSD
Results Point of Contact
- Title
- Steven R. Thorp, Ph.D., ABPP
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Steven R. Thorp, PhD
VA San Diego Healthcare System, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2007
First Posted
October 4, 2007
Study Start
March 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 19, 2015
Results First Posted
August 19, 2015
Record last verified: 2015-08