Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00539279
First received: October 2, 2007
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention
Combat Disorders
Post-traumatic Stress Disorder
Behavioral: Prolonged Exposure Therapy (PE)
Behavioral: Relaxation Training (RT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD symptoms (CAPS; PTSD Checklist), depressive symptoms (PHQ-9), and functional impairment (SF-36; Sheehan Disability Scale) [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wechsler Test of Adult Reading and 7 brief tests of executive functioning: Trail Making, Verbal Fluency, & Color-World Interference, Digit Span, Rey-Osterrieth Complex Figure Test, CA Verbal Learning Test-II, WI Card Sort Test [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Pre-treatment; post-treatment ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: Pre-treatment; post-treatment ] [ Designated as safety issue: No ]
  • Posttraumatic Cognitions Inventory [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
  • Posttraumatic Growth Inventory [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
  • Treatment Preferences and Satisfaction [ Time Frame: Session 3 and Session 12 ] [ Designated as safety issue: No ]
  • State-Trait Anxiety [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]
  • Mindfulness [ Time Frame: Pre-treatment, post-treatment, and 6-month follow-up points. ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: March 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 Name: Implosive therapy; flooding; systematic desensitization
Active Comparator: Arm 2
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 Name: Progressive Muscle Relaxation; Imagery Rehearsal; Breathing training

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).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans with primary diagnosis of chronic PTSD due to combat or non-sexual military trauma; comorbid mood and anxiety disorders are expected, and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms
  • Male
  • Age 60 or older; and
  • English literacy.

Exclusion Criteria:

  • Unmanaged psychosis or manic episodes in past year
  • Substance dependence or alcohol dependence in past 3 months
  • Concurrent psychotherapies targeting PTSD or exposure therapy for other anxiety symptoms [veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step programs for substance problems) will be eligible]
  • Severe cardiovascular or respiratory disease that would make it difficult to ensure regular attendance at psychotherapy sessions
  • Probable dementia (based on chart diagnosis); or
  • Head trauma resulting in loss of consciousness longer than 20 minutes.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539279

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Steven R. Thorp, PhD VA San Diego Healthcare System, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00539279     History of Changes
Other Study ID Numbers: CDA-2-009-07S
Study First Received: October 2, 2007
Last Updated: May 15, 2013
Health Authority: United States: Federal Government

Keywords provided by 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
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014