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

September 28, 2010 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center (152)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MEDVAMC Nightmare Treatment
Behavioral: MEDVAMC Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting
Experimental: 2
Videoconferencing nightmare Treatment
Behavioral: Telepsychiatry Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline & post-treatment
Baseline & post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Posttraumatic Cognitions Inventory (PTCI).
Time Frame: Baseline & post-treatment
Baseline & post-treatment
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Time Frame: Baseline & post-treatment
Baseline & post-treatment
Trauma Related Nightmare Survey (TRNS).
Time Frame: Baseline & post-treatment
Baseline & post-treatment
Mini-International Neuropsychiatric Interview (MINI)
Time Frame: Baseline
Baseline
Treatment Evaluation Inventory (TEI)
Time Frame: Post-treatment
Post-treatment
Client Satisfaction Questionnaire (CSQ)
Time Frame: Post-treatment
Post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Mary E. Long, PhD, Michael E. DeBakey VA Medical Center (152)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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