Combat Disorders, Post-traumatic Stress Disorder
Conditions
Keywords
Cognitive- Behavior Therapy, Combat Disorders, Elderly, Geriatrics, Implosive therapy, Neuropsychological Test, Post-traumatic Stress Disorder, Psychotherapy, Randomized Controlled Trial, Relaxation techniques
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).
Interventions
BEHAVIORALProlonged 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).
BEHAVIORALRelaxation Training (RT)
RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist (PCL) | 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. |
| Patient Health Questionnaire Depression Subscale (PHQ-9) | 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 |
| Clinician-Administered PTSD Scale Severity Score (CAPS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Cognitions Inventory (PTCI) | 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. |
| Global Neuropsychological Deficits (Standardized, Composite) | 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. |
| State-Trait Anxiety Inventory State Scale (STAI-S) | 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. |
| Sheehan Disability Scale (SDS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 41 |
| 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. | 46 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-Month Follow-Up Assessment | Lost to Follow-up | 1 | 7 |
| Post-Treatment Assessment | Lost to Follow-up | 12 | 9 |
| Treatment | Death | 1 | 0 |
| Treatment | Withdrawal by Subject | 10 | 8 |
Baseline characteristics
| Characteristic | Total | Relaxation Training (RT) | Prolonged Exposure Therapy (PE) |
|---|---|---|---|
| Age, Continuous | 65.54 Years STANDARD_DEVIATION 5.69 | 64.44 Years STANDARD_DEVIATION 4.49 | 66.51 Years STANDARD_DEVIATION 6.21 |
| Clinician-Administered PTSD Scale Severity Score (CAPS) | 67.11 units on a scale STANDARD_DEVIATION 17.83 | 72.98 units on a scale STANDARD_DEVIATION 14.64 | 66.02 units on a scale STANDARD_DEVIATION 14.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 41 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Global Neuropsychological Deficits (Standardized, Composite) | .38 standardized units on a scale STANDARD_DEVIATION 0.38 | .42 standardized units on a scale STANDARD_DEVIATION 0.41 | .32 standardized units on a scale STANDARD_DEVIATION 0.33 |
| Patient Health Questionnaire Depression Subscale (PHQ-9) | 13.28 units on a scale STANDARD_DEVIATION 6.2 | 15.12 units on a scale STANDARD_DEVIATION 5.17 | 12.13 units on a scale STANDARD_DEVIATION 6.57 |
| Posttraumatic Cognitions Inventory (PTCI) | 3.45 units on a scale STANDARD_DEVIATION 1.13 | 3.78 units on a scale STANDARD_DEVIATION 1.07 | 3.14 units on a scale STANDARD_DEVIATION 1.07 |
| PTSD Checklist (PCL) | 58.28 units on a scale STANDARD_DEVIATION 12.36 | 59.98 units on a scale STANDARD_DEVIATION 11.8 | 57.46 units on a scale STANDARD_DEVIATION 12.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 38 Participants | 31 Participants |
| Region of Enrollment United States | 87 participants | 46 participants | 41 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 87 Participants | 46 Participants | 41 Participants |
| Sheehan Disability Scale (SDS) | 18.19 units on a scale STANDARD_DEVIATION 8.09 | 18.83 units on a scale STANDARD_DEVIATION 7.95 | 18.15 units on a scale STANDARD_DEVIATION 8.03 |
| State-Trait Anxiety Inventory State Scale (STAI-S) | 43.08 units on a scale STANDARD_DEVIATION 5.96 | 41.67 units on a scale STANDARD_DEVIATION 6.13 | 44.46 units on a scale STANDARD_DEVIATION 5.46 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 46 |
| serious Total, serious adverse events | 0 / 41 | 0 / 46 |
Outcome results
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.
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale Severity Score (CAPS) | Baseline | 66.02 units on a scale | Standard Deviation 14.85 |
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale Severity Score (CAPS) | Post-Treatment | 48.48 units on a scale | Standard Deviation 24.58 |
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale Severity Score (CAPS) | 6-Month Follow-Up | 29.16 units on a scale | Standard Deviation 34.2 |
| Relaxation Training (RT) | Clinician-Administered PTSD Scale Severity Score (CAPS) | Baseline | 72.98 units on a scale | Standard Deviation 14.64 |
| Relaxation Training (RT) | Clinician-Administered PTSD Scale Severity Score (CAPS) | Post-Treatment | 64.45 units on a scale | Standard Deviation 15.32 |
| Relaxation Training (RT) | Clinician-Administered PTSD Scale Severity Score (CAPS) | 6-Month Follow-Up | 37.40 units on a scale | Standard Deviation 32.74 |
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
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Patient Health Questionnaire Depression Subscale (PHQ-9) | Baseline | 12.13 units on a scale | Standard Deviation 6.57 |
| Prolonged Exposure Therapy (PE) | Patient Health Questionnaire Depression Subscale (PHQ-9) | Post-Treatment | 10.88 units on a scale | Standard Deviation 7.67 |
| Prolonged Exposure Therapy (PE) | Patient Health Questionnaire Depression Subscale (PHQ-9) | 6-Month Follow-Up | 13.12 units on a scale | Standard Deviation 6.15 |
| Relaxation Training (RT) | Patient Health Questionnaire Depression Subscale (PHQ-9) | Baseline | 15.12 units on a scale | Standard Deviation 5.17 |
| Relaxation Training (RT) | Patient Health Questionnaire Depression Subscale (PHQ-9) | Post-Treatment | 14.80 units on a scale | Standard Deviation 5.75 |
| Relaxation Training (RT) | Patient Health Questionnaire Depression Subscale (PHQ-9) | 6-Month Follow-Up | 13.92 units on a scale | Standard Deviation 6.42 |
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.
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | PTSD Checklist (PCL) | Baseline | 57.46 units on a scale | Standard Deviation 12.66 |
| Prolonged Exposure Therapy (PE) | PTSD Checklist (PCL) | Post-Treatment | 47.00 units on a scale | Standard Deviation 18.91 |
| Prolonged Exposure Therapy (PE) | PTSD Checklist (PCL) | 6-Month Follow-Up | 58.37 units on a scale | Standard Deviation 13.77 |
| Relaxation Training (RT) | PTSD Checklist (PCL) | Baseline | 59.98 units on a scale | Standard Deviation 11.8 |
| Relaxation Training (RT) | PTSD Checklist (PCL) | Post-Treatment | 58.06 units on a scale | Standard Deviation 12.31 |
| Relaxation Training (RT) | PTSD Checklist (PCL) | 6-Month Follow-Up | 58.31 units on a scale | Standard Deviation 10.88 |
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.
Time frame: Pre-treatment, post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Global Neuropsychological Deficits (Standardized, Composite) | Baseline | .32 standardized units on a scale | Standard Deviation 0.33 |
| Prolonged Exposure Therapy (PE) | Global Neuropsychological Deficits (Standardized, Composite) | Post-Treatment | .35 standardized units on a scale | Standard Deviation 0.42 |
| Relaxation Training (RT) | Global Neuropsychological Deficits (Standardized, Composite) | Baseline | .42 standardized units on a scale | Standard Deviation 0.41 |
| Relaxation Training (RT) | Global Neuropsychological Deficits (Standardized, Composite) | Post-Treatment | .40 standardized units on a scale | Standard Deviation 0.42 |
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.
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Posttraumatic Cognitions Inventory (PTCI) | Baseline | 3.14 units on a scale | Standard Deviation 1.07 |
| Prolonged Exposure Therapy (PE) | Posttraumatic Cognitions Inventory (PTCI) | Post-Treatment | 2.80 units on a scale | Standard Deviation 1.08 |
| Prolonged Exposure Therapy (PE) | Posttraumatic Cognitions Inventory (PTCI) | 6-Month Follow-Up | 3.44 units on a scale | Standard Deviation 1.09 |
| Relaxation Training (RT) | Posttraumatic Cognitions Inventory (PTCI) | Baseline | 3.78 units on a scale | Standard Deviation 1.07 |
| Relaxation Training (RT) | Posttraumatic Cognitions Inventory (PTCI) | Post-Treatment | 3.72 units on a scale | Standard Deviation 1.04 |
| Relaxation Training (RT) | Posttraumatic Cognitions Inventory (PTCI) | 6-Month Follow-Up | 3.84 units on a scale | Standard Deviation 1.11 |
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.
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Sheehan Disability Scale (SDS) | Baseline | 18.15 units on a scale | Standard Deviation 8.03 |
| Prolonged Exposure Therapy (PE) | Sheehan Disability Scale (SDS) | Post-Treatment | 15.31 units on a scale | Standard Deviation 8.89 |
| Prolonged Exposure Therapy (PE) | Sheehan Disability Scale (SDS) | 6-Month Follow-Up | 21.06 units on a scale | Standard Deviation 7.44 |
| Relaxation Training (RT) | Sheehan Disability Scale (SDS) | Baseline | 18.83 units on a scale | Standard Deviation 7.95 |
| Relaxation Training (RT) | Sheehan Disability Scale (SDS) | Post-Treatment | 18.77 units on a scale | Standard Deviation 6.85 |
| Relaxation Training (RT) | Sheehan Disability Scale (SDS) | 6-Month Follow-Up | 17.71 units on a scale | Standard Deviation 7.1 |
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.
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | State-Trait Anxiety Inventory State Scale (STAI-S) | Baseline | 44.46 units on a scale | Standard Deviation 5.46 |
| Prolonged Exposure Therapy (PE) | State-Trait Anxiety Inventory State Scale (STAI-S) | Post-Treatment | 42.64 units on a scale | Standard Deviation 5.81 |
| Prolonged Exposure Therapy (PE) | State-Trait Anxiety Inventory State Scale (STAI-S) | 6-Month Follow-Up | 43.72 units on a scale | Standard Deviation 5.96 |
| Relaxation Training (RT) | State-Trait Anxiety Inventory State Scale (STAI-S) | Baseline | 41.67 units on a scale | Standard Deviation 6.13 |
| Relaxation Training (RT) | State-Trait Anxiety Inventory State Scale (STAI-S) | Post-Treatment | 43.75 units on a scale | Standard Deviation 5.1 |
| Relaxation Training (RT) | State-Trait Anxiety Inventory State Scale (STAI-S) | 6-Month Follow-Up | 42.63 units on a scale | Standard Deviation 7.07 |