Clinical trial NCT00837109: Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
Official title: Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sleep Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, prior to each session, post-assessment, 3-month follow-up
Secondary outcomes:
measure: Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Baseline, post-assessment, 3-month follow-up
measure: Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),
timeFrame: Baseline, post-assessment, 3-month follow-up
measure: Trauma Related Nightmare Survey (TRNS)
timeFrame: Baseline, post-assessment, 3-month follow-up
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Baseline, post-assessment, 3-month follow-up
measure: Modules of the Mini-International Neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Treatment Evaluation Inventory (TEI)
timeFrame: Post-assessment
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-assessment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center (152)
name: Mary E. Long, PhD
role: PRINCIPAL_INVESTIGATOR
References: