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

This study has been terminated.
(Primary investigator is no longer a part of the VA.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00837382
First received: February 3, 2009
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Sleep Disorders
 Behavioral: MEDVAMC Nightmare Treatment
Behavioral: Telepsychiatry Nightmare Treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline & post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic Cognitions Inventory (PTCI). [ Time Frame: Baseline & post-treatment ] [ Designated as safety issue: No ]
  • The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI) [ Time Frame: Baseline & post-treatment ] [ Designated as safety issue: No ]
  • Trauma Related Nightmare Survey (TRNS). [ Time Frame: Baseline & post-treatment ] [ Designated as safety issue: No ]
  • Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Treatment Evaluation Inventory (TEI) [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837382

Locations
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Mary E. Long, PhD Michael E. DeBakey VA Medical Center (152)
  More Information

No publications provided

Responsible Party: Long, Mary - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00837382     History of Changes
Other Study ID Numbers: H-24157
Study First Received: February 3, 2009
Last Updated: September 28, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 22, 2013