Combat DisordersNCT00539279
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
A study testing Prolonged Exposure Therapy (PE) and Relaxation Training (RT) in people with Combat Disorders and Post-traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Combat Disorders, Post-traumatic Stress Disorder
- What is being tested?
- Prolonged Exposure Therapy (PE) and Relaxation Training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
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).
Read the 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).
- Conditions
- Combat Disorders, Post-traumatic Stress Disorder
- Being tested
- Prolonged Exposure Therapy (PE), Relaxation Training (RT)
- Keywords
- Cognitive- Behavior Therapy, Combat Disorders, Elderly, Geriatrics, Implosive therapy, Neuropsychological Test, Post-traumatic Stress Disorder, Psychotherapy, Randomized Controlled Trial, Relaxation techniques
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure Therapy (PE)Behavioural
Also called Implosive therapy; flooding; systematic desensitization
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)Behavioural
Also called Progressive Muscle Relaxation; Breathing training
RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure Therapy (PE) | Experimental | Prolonged Exposure Therapy (PE) Receives: Behavioral: Prolonged Exposure Therapy (PE) |
| Relaxation Training (RT) | Active comparator | Relaxation Training (RT) Receives: Behavioral: Relaxation Training (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Pre-treatment, post-treatment, and 6-month follow-up
Secondary outcomes (4)
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.
Measured: Pre-treatment, post-treatment, and 6-month follow-up
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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Combat DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven R. Thorp, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539279
- Sponsor's protocol ID
- CDA-2-009-07S
- Status last verified
- Aug 2015
- First submitted
- 2 Oct 2007
- Last updated
- 19 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32216149Thorp 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.
PubMed 30978622
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00539279
- Acronym / sponsor ID
- CDA-2-009-07S
- Conditions
- Combat Disorders, Post-traumatic Stress Disorder
- Keywords
- Cognitive- Behavior Therapy, Combat Disorders, Elderly, Geriatrics, Implosive therapy, Neuropsychological Test, Post-traumatic Stress Disorder, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 19 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure Therapy (PE) | Experimental | Behavioral: Prolonged Exposure Therapy (PE)Prolonged Exposure Therapy (PE) |
| Relaxation Training (RT) | Active comparator | Behavioral: Relaxation Training (RT)Relaxation Training (RT) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure Therapy (PE)Also: Implosive therapy; flooding; systematic desensitizationPE 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). | Behavioural | Prolonged Exposure Therapy (PE) |
| Relaxation Training (RT)Also: Progressive Muscle Relaxation; Breathing trainingRT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training. | Behavioural | Relaxation Training (RT) |
Primary outcome
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.
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
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.
4 secondary outcomes
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
State-Trait Anxiety Inventory State Scale (STAI-S)
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
Sheehan Disability Scale (SDS)
Time frame: Pre-treatment, post-treatment, and 6-month follow-up
Global Neuropsychological Deficits (Standardized, Composite)
Time frame: Pre-treatment, post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32216149Walter 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.
- Derived from this study: PubMed 30978622Thorp 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.
- Click here for more information about this study: Treatment of Older Veterans with Chronic Posttraumatic Stress DisorderLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R. Thorp, PhD principal investigator
VA San Diego Healthcare System, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy (PE) and Relaxation Training (RT) in people with Combat Disorders and Post-traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL) (time frame: Pre-treatment, post-treatment, and 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00539279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.