Study Stopped
Primary investigator is no longer a part of the VA.
Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
1 other identifier
interventional
7
1 country
1
Brief Summary
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although combat-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for returning veterans. This study tests how well this treatment works in treating combat nightmares in veterans who also have PTSD from experiencing a traumatic event.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 29, 2010
September 1, 2010
7 months
February 3, 2009
September 28, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
Baseline & post-treatment
Secondary Outcomes (6)
Posttraumatic Cognitions Inventory (PTCI).
Baseline & post-treatment
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Baseline & post-treatment
Trauma Related Nightmare Survey (TRNS).
Baseline & post-treatment
Mini-International Neuropsychiatric Interview (MINI)
Baseline
Treatment Evaluation Inventory (TEI)
Post-treatment
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALMEDVAMC Nightmare Treatment
2
EXPERIMENTALVideoconferencing nightmare Treatment
Interventions
Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing
Eligibility Criteria
You may qualify if:
- Patients for the open trial will be
- OEF/OIF veterans (aged 18-64);
- English-speaking;
- currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC);
- reporting at least one combat or war zone associated PTNM in the past week;
- have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
- consenting to be in an open trial for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.
- Pilot Study: Patients for the pilot study will be
- OEF/OIF veterans (aged 18-64);
- English-speaking;
- currently enrolled in the Conroe CBOC for their primary or mental health care;
- reporting at least one combat or war zone associated PTNM in the past week;
- have an existing PTSD ICD-9-CM diagnosis; and
- consenting to be in the pilot study for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.
You may not qualify if:
- Patients will be excluded for the following reasons:
- current active suicidal/homicidal ideation and intent;
- current substance dependence;
- a diagnosis of bipolar or psychosis;
- active participation in another psychosocial treatment for PTSD;
- prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
- Patients interested in receiving the intervention will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E. Long, PhD
Michael E. DeBakey VA Medical Center (152)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 5, 2009
Study Start
January 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 29, 2010
Record last verified: 2010-09