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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00837109
• Other study ID #: H-24172
• Status: Terminated
• Phase: N/A
• First received: February 3, 2009
• Last updated: September 28, 2010
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Veteran Nightmare Treatment
Veteran Nightmare Treatment Using Imagery Rescripting
• Treatment-as-usual
Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Posttraumatic Cognitions Inventory (PTCI)		Baseline, post-assessment, 3-month follow-up	No
Secondary	Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),		Baseline, post-assessment, 3-month follow-up	No
Secondary	Trauma Related Nightmare Survey (TRNS)		Baseline, post-assessment, 3-month follow-up	No
Secondary	Clinician-Administered PTSD Scale (CAPS)		Baseline, post-assessment, 3-month follow-up	No
Secondary	Modules of the Mini-International Neuropsychiatric Interview (MINI)		Baseline	No
Secondary	Treatment Evaluation Inventory (TEI)		Post-assessment	No
Secondary	Client Satisfaction Questionnaire (CSQ)		Post-assessment	No