Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
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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) |
- 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 ]
- 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 |
Inclusion Criteria:
Participants will be:
- patients at the VA in the Trauma Recovery Program;
- English-speaking;
- reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
- have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
- 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
- with current active suicidal/homicidal ideation and intent;
- with current substance dependence;
- 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| United States, Texas | |
| Michael E. DeBakey VA Medical Center (152) | |
| Houston, Texas, United States, 77030 | |
| 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:
|
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 23, 2013