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Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)

This study has been terminated.
(Primary investigator is no longer a part of the VA)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837109
First Posted: February 5, 2009
Last Update Posted: September 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  Purpose
Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-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 trauma-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 veterans.

Condition Intervention
Stress Disorders, Post-Traumatic Sleep Disorders Behavioral: Veteran Nightmare Treatment Behavioral: Treatment-as-usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline, prior to each session, post-assessment, 3-month follow-up ]

Secondary Outcome Measures:
  • Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Baseline, post-assessment, 3-month follow-up ]
  • Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI), [ Time Frame: Baseline, post-assessment, 3-month follow-up ]
  • Trauma Related Nightmare Survey (TRNS) [ Time Frame: Baseline, post-assessment, 3-month follow-up ]
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline, post-assessment, 3-month follow-up ]
  • Modules of the Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Baseline ]
  • Treatment Evaluation Inventory (TEI) [ Time Frame: Post-assessment ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-assessment ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Imagery Rescripting Nightmare Treatment
Behavioral: Veteran Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting
Active Comparator: 2
Treatment-as-usual in the Trauma Recovery Program
Behavioral: Treatment-as-usual
Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants will be:

  1. patients at the VA in the Trauma Recovery Program;
  2. English-speaking;
  3. reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
  4. have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
  5. consenting to be randomized into treatment.

In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision and treatment integrity ratings. Participants receiving other forms of group or individual psychotherapy and/or psychotropic medication are eligible for the nightmare treatment condition of the study, provided that those interventions do not specifically target nightmares or PTSD. Thus, the study interventions will be in addition to standard care, except as indicated above.

Exclusion Criteria:

Patients

  1. with current active suicidal/homicidal ideation and intent;
  2. with current substance dependence;
  3. a diagnosis of bipolar or psychosis; 4) prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).

Patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their PTSD symptoms. Patients 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837109


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

Responsible Party: Long, Mary - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00837109     History of Changes
Other Study ID Numbers: H-24172
First Submitted: February 3, 2009
First Posted: February 5, 2009
Last Update Posted: September 29, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms