Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00539279
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Combat Disorders; Post-traumatic Stress Disorder	Behavioral: Prolonged Exposure Therapy (PE); Behavioral: Relaxation Training (RT)	N/A

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

• Study Type: Interventional
• 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: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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 Names: 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 Names: Progressive Muscle Relaxation; Breathing training

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA San Diego Healthcare System, San Diego	San Diego	California	United States	92161

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00539279
• Other Study ID Numbers: CDA-2-009-07S
• First Posted: Oct 4, 2007
• Last Update Posted: Aug 19, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by US Department of Veterans Affairs: 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

Study Results

Participant Flow

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Period Title: Treatment
STARTED	41	46
COMPLETED	30	38
NOT COMPLETED	11	8
Period Title: Treatment
STARTED	30	38
COMPLETED	18	29
NOT COMPLETED	12	9
Period Title: Treatment
STARTED	18	29
COMPLETED	17	22
NOT COMPLETED	1	7

Baseline Characteristics

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)	Total
Arm/Group Description	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).	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.	Total of all reporting groups
Overall Participants	41	46	87
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	66.51 (6.21)	64.44 (4.49)	65.54 (5.69)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	41 100%	46 100%	87 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.9%	5 10.9%	7 8%
Not Hispanic or Latino	39 95.1%	41 89.1%	80 92%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 2.2%	1 1.1%
Asian	2 4.9%	2 4.3%	4 4.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 17.1%	4 8.7%	11 12.6%
White	31 75.6%	38 82.6%	69 79.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.4%	1 2.2%	2 2.3%
Region of Enrollment (participants) [Number]
United States	41 100%	46 100%	87 100%
PTSD Checklist (PCL) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	57.46 (12.66)	59.98 (11.80)	58.28 (12.36)
Patient Health Questionnaire Depression Subscale (PHQ-9) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.13 (6.57)	15.12 (5.17)	13.28 (6.20)
Clinician-Administered PTSD Scale Severity Score (CAPS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	66.02 (14.85)	72.98 (14.64)	67.11 (17.83)
Posttraumatic Cognitions Inventory (PTCI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.14 (1.07)	3.78 (1.07)	3.45 (1.13)
State-Trait Anxiety Inventory State Scale (STAI-S) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.46 (5.46)	41.67 (6.13)	43.08 (5.96)
Sheehan Disability Scale (SDS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.15 (8.03)	18.83 (7.95)	18.19 (8.09)
Global Neuropsychological Deficits (Standardized, Composite) (standardized units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [standardized units on a scale]	.32 (.33)	.42 (.41)	.38 (.38)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	57.46 (12.66)	59.98 (11.80)
Post-Treatment	47.00 (18.91)	58.06 (12.31)
6-Month Follow-Up	58.37 (13.77)	58.31 (10.88)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	3.14 (1.07)	3.78 (1.07)
Post-Treatment	2.80 (1.08)	3.72 (1.04)
6-Month Follow-Up	3.44 (1.09)	3.84 (1.11)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	44.46 (5.46)	41.67 (6.13)
Post-Treatment	42.64 (5.81)	43.75 (5.10)
6-Month Follow-Up	43.72 (5.96)	42.63 (7.07)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	12.13 (6.57)	15.12 (5.17)
Post-Treatment	10.88 (7.67)	14.80 (5.75)
6-Month Follow-Up	13.12 (6.15)	13.92 (6.42)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	18.15 (8.03)	18.83 (7.95)
Post-Treatment	15.31 (8.89)	18.77 (6.85)
6-Month Follow-Up	21.06 (7.44)	17.71 (7.10)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	.32 (.33)	.42 (.41)
Post-Treatment	.35 (.42)	.40 (.42)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Relaxation Training (RT)
Arm/Group Description	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).	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.
Measure Participants	41	46
Baseline	66.02 (14.85)	72.98 (14.64)
Post-Treatment	48.48 (24.58)	64.45 (15.32)
6-Month Follow-Up	29.16 (34.20)	37.40 (32.74)

Adverse Events

Arm/Group Title	Prolonged Exposure Therapy (PE)		Relaxation Training (RT)
Arm/Group Description	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).		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.
All Cause Mortality
	Prolonged Exposure Therapy (PE)		Relaxation Training (RT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Prolonged Exposure Therapy (PE)		Relaxation Training (RT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Prolonged Exposure Therapy (PE)		Relaxation Training (RT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/46 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.