Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Combat Disorders; Post-traumatic Stress Disorder	Behavioral: Prolonged Exposure Therapy (PE); Behavioral: Relaxation Training (RT)	Not Applicable

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	87 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Study Start Date :	March 2009
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Prolonged Exposure Therapy (PE); Prolonged Exposure Therapy (PE)	Behavioral: Prolonged Exposure Therapy (PE); 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).; Other Name: Implosive therapy; flooding; systematic desensitization
Active Comparator: Relaxation Training (RT); Relaxation Training (RT)	Behavioral: Relaxation Training (RT); RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.; Other Name: Progressive Muscle Relaxation; Breathing training

Outcome Measures

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Primary Outcome Measures :

1. PTSD Checklist (PCL) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]
   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.
2. Patient Health Questionnaire Depression Subscale (PHQ-9) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]

   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

3. Clinician-Administered PTSD Scale Severity Score (CAPS) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]
   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.

Secondary Outcome Measures :

1. Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]
   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.
2. State-Trait Anxiety Inventory State Scale (STAI-S) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]
   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.
3. Sheehan Disability Scale (SDS) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up ]
   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.
4. Global Neuropsychological Deficits (Standardized, Composite) [ Time Frame: Pre-treatment, post-treatment ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Steven R. Thorp, PhD	VA San Diego Healthcare System, San Diego

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about this study: Treatment of Older Veterans with Chronic Posttraumatic Stress Disorder 

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00539279 History of Changes
Other Study ID Numbers:	CDA-2-009-07S
First Posted:	October 4, 2007
Results First Posted:	August 19, 2015
Last Update Posted:	August 19, 2015
Last Verified:	August 2015

Keywords provided by VA Office of Research and Development:

Cognitive- Behavior Therapy; Combat Disorders; Elderly; Geriatrics; Implosive therapy	Neuropsychological Test; Post-traumatic Stress Disorder; Psychotherapy; Randomized Controlled Trial; Relaxation techniques

Additional relevant MeSH terms:

Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders	Pathologic Processes; Trauma and Stressor Related Disorders; Mental Disorders