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Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder

Primary Purpose

Combat Disorders, Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy (PE)
Relaxation Training (RT)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Combat Disorders focused on measuring Cognitive- Behavior Therapy, Combat Disorders, Elderly, Geriatrics, Implosive therapy, Neuropsychological Test, Post-traumatic Stress Disorder, Psychotherapy, Randomized Controlled Trial, Relaxation techniques

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • VA San Diego Healthcare System, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged Exposure Therapy (PE)

Relaxation Training (RT)

Arm Description

Prolonged Exposure Therapy (PE)

Relaxation Training (RT)

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 2, 2007
Last Updated
August 11, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00539279
Brief Title
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Official Title
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure Therapy (PE)
Arm Type
Experimental
Arm Description
Prolonged Exposure Therapy (PE)
Arm Title
Relaxation Training (RT)
Arm Type
Active Comparator
Arm Description
Relaxation Training (RT)
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy (PE)
Other Intervention Name(s)
Implosive therapy; flooding; systematic desensitization
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training (RT)
Other Intervention Name(s)
Progressive Muscle Relaxation; Breathing training
Intervention Description
RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
Primary Outcome Measure Information:
Title
PTSD Checklist (PCL)
Description
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.
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Title
Patient Health Questionnaire Depression Subscale (PHQ-9)
Description
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
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Title
Clinician-Administered PTSD Scale Severity Score (CAPS)
Description
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.
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Secondary Outcome Measure Information:
Title
Posttraumatic Cognitions Inventory (PTCI)
Description
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.
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Title
State-Trait Anxiety Inventory State Scale (STAI-S)
Description
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.
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Title
Sheehan Disability Scale (SDS)
Description
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.
Time Frame
Pre-treatment, post-treatment, and 6-month follow-up
Title
Global Neuropsychological Deficits (Standardized, Composite)
Description
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.
Time Frame
Pre-treatment, post-treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R. Thorp, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32216149
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.
Results Reference
derived
PubMed Identifier
30978622
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.
Results Reference
derived
Links:
URL
http://ptsdstudies.weebly.com/study-3-older-adults.html
Description
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