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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:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00837109
First received: February 3, 2009
Last updated: September 28, 2010
Last verified: September 2010
  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 Blind (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 Department of Veterans Affairs:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Baseline, post-assessment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI), [ Time Frame: Baseline, post-assessment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Trauma Related Nightmare Survey (TRNS) [ Time Frame: Baseline, post-assessment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline, post-assessment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Modules of the Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Treatment Evaluation Inventory (TEI) [ Time Frame: Post-assessment ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-assessment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837109

Locations
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
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: NCT00837109     History of Changes
Other Study ID Numbers: H-24172
Study First Received: February 3, 2009
Last Updated: September 28, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 27, 2014