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.

Study Overview

• Status: Terminated
• Conditions: Stress Disorders, Post-Traumatic; Sleep Disorders
• Intervention / Treatment: Behavioral: Veteran Nightmare Treatment; Behavioral: Treatment-as-usual

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center (152)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Mary E. Long, PhD, Michael E. DeBakey VA Medical Center (152)

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 5, 2009

Study Record Updates

• Last Update Posted (Estimate): September 29, 2010
• Last Update Submitted That Met QC Criteria: September 28, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Trauma and Stressor Related Disorders; Disease; Sleep Wake Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: H-24172