NCT00837382

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

7 months

First QC Date

February 3, 2009

Last Update Submit

September 28, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Baseline & post-treatment

Secondary Outcomes (6)

  • Posttraumatic Cognitions Inventory (PTCI).

    Baseline & post-treatment

  • The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)

    Baseline & post-treatment

  • Trauma Related Nightmare Survey (TRNS).

    Baseline & post-treatment

  • Mini-International Neuropsychiatric Interview (MINI)

    Baseline

  • Treatment Evaluation Inventory (TEI)

    Post-treatment

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

MEDVAMC Nightmare Treatment

Behavioral: MEDVAMC Nightmare Treatment

2

EXPERIMENTAL

Videoconferencing nightmare Treatment

Behavioral: Telepsychiatry Nightmare Treatment

Interventions

Veteran Nightmare Treatment Using Imagery Rescripting

1

Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSleep Wake Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations