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

February 3, 2009
September 28, 2010
February 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00837109 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Sleep Disorders
  • Behavioral: Veteran Nightmare Treatment
    Veteran Nightmare Treatment Using Imagery Rescripting
  • Behavioral: Treatment-as-usual
    Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)
  • Experimental: 1
    Imagery Rescripting Nightmare Treatment
    Intervention: Behavioral: Veteran Nightmare Treatment
  • Active Comparator: 2
    Treatment-as-usual in the Trauma Recovery Program
    Intervention: Behavioral: Treatment-as-usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
June 2010
June 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837109
H-24172
No
Long, Mary - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mary E. Long, PhD Michael E. DeBakey VA Medical Center (152)
Department of Veterans Affairs
September 2010

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