Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00837382
• Other study ID #: H-24157
• Status: Terminated
• Phase: N/A
• First received: February 3, 2009
• Last updated: September 28, 2010
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• MEDVAMC Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting
• Telepsychiatry Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)		Baseline & post-treatment	No
Secondary	Posttraumatic Cognitions Inventory (PTCI).		Baseline & post-treatment	No
Secondary	The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)		Baseline & post-treatment	No
Secondary	Trauma Related Nightmare Survey (TRNS).		Baseline & post-treatment	No
Secondary	Mini-International Neuropsychiatric Interview (MINI)		Baseline	No
Secondary	Treatment Evaluation Inventory (TEI)		Post-treatment	No
Secondary	Client Satisfaction Questionnaire (CSQ)		Post-treatment	No