Clinical trial NCT00837382: Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
Official title: Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sleep Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-02-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Patients for the open trial will be

1. OEF/OIF veterans (aged 18-64);
2. English-speaking;
3. currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC);
4. reporting at least one combat or war zone associated PTNM in the past week;
5. have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
6. 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

1. OEF/OIF veterans (aged 18-64);
2. English-speaking;
3. currently enrolled in the Conroe CBOC for their primary or mental health care;
4. reporting at least one combat or war zone associated PTNM in the past week;
5. have an existing PTSD ICD-9-CM diagnosis; and
6. 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.

Exclusion Criteria:

Patients will be excluded for the following reasons:

1. current active suicidal/homicidal ideation and intent;
2. current substance dependence;
3. a diagnosis of bipolar or psychosis;
4. active participation in another psychosocial treatment for PTSD;
5. 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline & post-treatment
Secondary outcomes:
measure: Posttraumatic Cognitions Inventory (PTCI).
timeFrame: Baseline & post-treatment
measure: The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
timeFrame: Baseline & post-treatment
measure: Trauma Related Nightmare Survey (TRNS).
timeFrame: Baseline & post-treatment
measure: Mini-International Neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Treatment Evaluation Inventory (TEI)
timeFrame: Post-treatment
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center (152)
name: Mary E. Long, PhD
role: PRINCIPAL_INVESTIGATOR
References: