Clinical trial NCT00539279: Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Official title: Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Combat Disorders
Post-traumatic Stress Disorder
Keywords: Cognitive- Behavior Therapy
Combat Disorders
Elderly
Geriatrics
Implosive therapy
Neuropsychological Test
Post-traumatic Stress Disorder
Psychotherapy
Randomized Controlled Trial
Relaxation techniques
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-10-04
Enrollment: 87
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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).

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.

Primary outcomes:
measure: PTSD Checklist (PCL)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
measure: Patient Health Questionnaire Depression Subscale (PHQ-9)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
measure: Clinician-Administered PTSD Scale Severity Score (CAPS)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
Secondary outcomes:
measure: Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
measure: State-Trait Anxiety Inventory State Scale (STAI-S)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
measure: Sheehan Disability Scale (SDS)
timeFrame: Pre-treatment, post-treatment, and 6-month follow-up
measure: Global Neuropsychological Deficits (Standardized, Composite)
timeFrame: Pre-treatment, post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Steven R. Thorp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Thorp 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.