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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Experimental | Prolonged Exposure Therapy (PE) |
|
| Relaxation Training (RT) | Active Comparator | Relaxation Training (RT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R. Thorp, PhD | VA San Diego Healthcare System, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32216149 | Derived | 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. | |
| 30978622 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study: Treatment of Older Veterans with Chronic Posttraumatic Stress Disorder | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolonged Exposure Therapy (PE) | 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). |
| FG001 | Relaxation Training (RT) | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
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| Post-Treatment Assessment |
| ||||||||||||||||||||||
| 6-Month Follow-Up Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolonged Exposure Therapy (PE) | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prolonged Exposure Therapy (PE) | 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). |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven R. Thorp, Ph.D., ABPP | VA San Diego Healthcare System | (858) 552-8585 | 2468 | Steven.Thorp@va.gov |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| D055868 | Floods |
| D012064 | Relaxation Therapy |
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| Relaxation Training (RT) | Behavioral | RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training. |
|
|
| 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 |
| 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 |
| 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 |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 |
| Relaxation Training (RT) |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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 | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | standardized units on a scale |
|
| OG001 | Relaxation Training (RT) | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | standardized units on a scale | Pre-treatment, post-treatment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment, post-treatment, and 6-month follow-up |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Relaxation Training (RT) | 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. | 0 | 46 | 0 | 46 |
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| D055907 | Climatic Processes |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D000077587 | Natural Disasters |
| D004190 | Disasters |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D006990 | Hypnosis |
| 6-Month Follow-Up |
|
| 6-Month Follow-Up |
|
| 6-Month Follow-Up |
|
| 6-Month Follow-Up |
|
| 6-Month Follow-Up |
|