Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)

NCT00837109 | Terminated

• 1 other identifier: H-24172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

1

EXPERIMENTAL

Imagery Rescripting Nightmare Treatment

Behavioral: Veteran Nightmare Treatment

2

ACTIVE COMPARATOR

Treatment-as-usual in the Trauma Recovery Program

Behavioral: Treatment-as-usual

Interventions

Veteran Nightmare Treatment BEHAVIORAL

Veteran Nightmare Treatment Using Imagery Rescripting

1

Treatment-as-usual BEHAVIORAL

Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)

2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary E. Long, PhD

  Michael E. DeBakey VA Medical Center (152)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 5, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

US (1)