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Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Stress Disorders, Post-Traumatic, Sleep Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MEDVAMC Nightmare Treatment
Telepsychiatry Nightmare Treatment
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients for the open trial will be

  1. OEF/OIF veterans (aged 18-64);
  2. English-speaking;
  3. currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC);
  4. reporting at least one combat or war zone associated PTNM in the past week;
  5. have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
  6. consenting to be in an open trial for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.

Pilot Study: Patients for the pilot study will be

  1. OEF/OIF veterans (aged 18-64);
  2. English-speaking;
  3. currently enrolled in the Conroe CBOC for their primary or mental health care;
  4. reporting at least one combat or war zone associated PTNM in the past week;
  5. have an existing PTSD ICD-9-CM diagnosis; and
  6. consenting to be in the pilot study for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.

Exclusion Criteria:

Patients will be excluded for the following reasons:

  1. current active suicidal/homicidal ideation and intent;
  2. current substance dependence;
  3. a diagnosis of bipolar or psychosis;
  4. active participation in another psychosocial treatment for PTSD;
  5. prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).

Patients interested in receiving the intervention 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

Experimental

Arm Label

1

2

Arm Description

MEDVAMC Nightmare Treatment

Videoconferencing nightmare Treatment

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)

Secondary Outcome Measures

Posttraumatic Cognitions Inventory (PTCI).
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Trauma Related Nightmare Survey (TRNS).
Mini-International Neuropsychiatric Interview (MINI)
Treatment Evaluation Inventory (TEI)
Client Satisfaction Questionnaire (CSQ)

Full Information

First Posted
February 3, 2009
Last Updated
September 28, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00837382
Brief Title
Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
Official Title
Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With 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
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 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
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-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 combat-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 returning veterans. This study tests how well this treatment works in treating combat nightmares in veterans who also have PTSD from experiencing a traumatic event.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MEDVAMC Nightmare Treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Videoconferencing nightmare Treatment
Intervention Type
Behavioral
Intervention Name(s)
MEDVAMC Nightmare Treatment
Intervention Description
Veteran Nightmare Treatment Using Imagery Rescripting
Intervention Type
Behavioral
Intervention Name(s)
Telepsychiatry Nightmare Treatment
Intervention Description
Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
Time Frame
Baseline & post-treatment
Secondary Outcome Measure Information:
Title
Posttraumatic Cognitions Inventory (PTCI).
Time Frame
Baseline & post-treatment
Title
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Time Frame
Baseline & post-treatment
Title
Trauma Related Nightmare Survey (TRNS).
Time Frame
Baseline & post-treatment
Title
Mini-International Neuropsychiatric Interview (MINI)
Time Frame
Baseline
Title
Treatment Evaluation Inventory (TEI)
Time Frame
Post-treatment
Title
Client Satisfaction Questionnaire (CSQ)
Time Frame
Post-treatment

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: Patients for the open trial will be OEF/OIF veterans (aged 18-64); English-speaking; currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC); reporting at least one combat or war zone associated PTNM in the past week; have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and consenting to be in an open trial for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision. Pilot Study: Patients for the pilot study will be OEF/OIF veterans (aged 18-64); English-speaking; currently enrolled in the Conroe CBOC for their primary or mental health care; reporting at least one combat or war zone associated PTNM in the past week; have an existing PTSD ICD-9-CM diagnosis; and consenting to be in the pilot study for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision. Exclusion Criteria: Patients will be excluded for the following reasons: current active suicidal/homicidal ideation and intent; current substance dependence; a diagnosis of bipolar or psychosis; active participation in another psychosocial treatment for PTSD; prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares). Patients interested in receiving the intervention 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

Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)

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