Back to resultsRandomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
Primary Purpose
Stress Disorders, Post-Traumatic, Sleep Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Veteran Nightmare Treatment
Treatment-as-usual
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
Eligibility Criteria
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.
Sites / Locations
- Michael E. DeBakey VA Medical Center (152)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Imagery Rescripting Nightmare Treatment
Treatment-as-usual in the Trauma Recovery Program
Outcomes
Primary Outcome Measures
Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
Secondary Outcome Measures
Posttraumatic Cognitions Inventory (PTCI)
Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),
Trauma Related Nightmare Survey (TRNS)
Clinician-Administered PTSD Scale (CAPS)
Modules of the Mini-International Neuropsychiatric Interview (MINI)
Treatment Evaluation Inventory (TEI)
Client Satisfaction Questionnaire (CSQ)
Full Information
NCT ID
NCT00837109
First Posted
February 3, 2009
Last Updated
September 28, 2010
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00837109
Brief Title
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
Primary investigator is no longer a part of the VA
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Sleep Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Imagery Rescripting Nightmare Treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment-as-usual in the Trauma Recovery Program
Intervention Type
Behavioral
Intervention Name(s)
Veteran Nightmare Treatment
Intervention Description
Veteran Nightmare Treatment Using Imagery Rescripting
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Posttraumatic Cognitions Inventory (PTCI)
Time Frame
Baseline, post-assessment, 3-month follow-up
Title
Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),
Time Frame
Baseline, post-assessment, 3-month follow-up
Title
Trauma Related Nightmare Survey (TRNS)
Time Frame
Baseline, post-assessment, 3-month follow-up
Title
Clinician-Administered PTSD Scale (CAPS)
Time Frame
Baseline, post-assessment, 3-month follow-up
Title
Modules of the Mini-International Neuropsychiatric Interview (MINI)
Time Frame
Baseline
Title
Treatment Evaluation Inventory (TEI)
Time Frame
Post-assessment
Title
Client Satisfaction Questionnaire (CSQ)
Time Frame
Post-assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E. Long, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center (152)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
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