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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)

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ClinicalTrials.gov Identifier: NCT00837382
Recruitment Status : Terminated (Primary investigator is no longer a part of the VA.)
First Posted : February 5, 2009
Last Update Posted : September 29, 2010
Sponsor:
Information provided by:
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE February 3, 2009
First Posted Date  ICMJE February 5, 2009
Last Update Posted Date September 29, 2010
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline & post-treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
  • Posttraumatic Cognitions Inventory (PTCI). [ Time Frame: Baseline & post-treatment ]
  • The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI) [ Time Frame: Baseline & post-treatment ]
  • Trauma Related Nightmare Survey (TRNS). [ Time Frame: Baseline & post-treatment ]
  • Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Baseline ]
  • Treatment Evaluation Inventory (TEI) [ Time Frame: Post-treatment ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
Official Title  ICMJE Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Post-Traumatic
  • Sleep Disorders
Intervention  ICMJE
  • Behavioral: MEDVAMC Nightmare Treatment
    Veteran Nightmare Treatment Using Imagery Rescripting
  • Behavioral: Telepsychiatry Nightmare Treatment
    Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing
Study Arms  ICMJE
  • Experimental: 1
    MEDVAMC Nightmare Treatment
    Intervention: Behavioral: MEDVAMC Nightmare Treatment
  • Experimental: 2
    Videoconferencing nightmare Treatment
    Intervention: Behavioral: Telepsychiatry Nightmare Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: February 3, 2009)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00837382
Other Study ID Numbers  ICMJE H-24157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Long, Mary - Principal Investigator, Department of Veterans Affairs
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary E. Long, PhD Michael E. DeBakey VA Medical Center (152)
PRS Account VA Office of Research and Development
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP