Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function

This study has been completed.
Sponsor:
Collaborators:
Duke University
Durham VA Medical Center
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT00374738
First received: September 7, 2006
Last updated: May 10, 2016
Last verified: May 2016

September 7, 2006
May 10, 2016
November 2006
September 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00374738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function

Our specific aims are:

  1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans
  2. To examine the effects of GIFT on fronto-limbic brain function and
  3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.

Guided imagery is a complementary and alternative treatment (CAM) modality. This directed meditation technique uses healing imagery to promote recovery in a variety of illnesses, including cancer, heart disease and, more recently, posttraumatic stress disorder (PTSD). PTSD is a severe and disabling anxiety disorder. It is among the most common mental disorders, affecting 10% of women in the United States during their lifetime. Sexual assault is the most common cause of PTSD. Similarly, military sexual trauma (MST) is disturbingly common among women in the armed forces. At least 20% of women veterans using VA services report a history of sexual assault. Unfortunately, high rates of MST-related PTSD are anticipated among women currently deployed to Iraq and Afghanistan.

To address this issue, we will evaluate a guided imagery intervention for women veterans who have MST-related PTSD. We will evaluate the efficacy of Guided Imagery for Trauma (GIFT) in decreasing PTSD symptoms. Using brain-imaging techniques, this research will examine the effects of GIFT on brain function in the areas associated with PTSD. We will also examine the effects of GIFT on neurosteroids, which are candidate modulators of PTSD symptoms, and may also represent novel targets for therapeutic intervention.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stress Disorders
Behavioral: Guided Imagery for Trauma (GIFT)
Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.
  • Experimental: GIFT Intervention
    Guided Imagery for Trauma (GIFT)
    Intervention: Behavioral: Guided Imagery for Trauma (GIFT)
  • No Intervention: Music Control
    Relaxing Music Audio control; same music used in guided imagery, with no narrative voice.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18-65
  • Status as a woman veteran
  • Receives care at the Durham VAMC
  • History of MST
  • DSM-IV diagnosis of PTSD, confirmed by CAPS interview
  • Able to participate in a research interview in English
  • Regular telephone access

Exclusion Criteria:

  • Current diagnosis of organic or psychotic mental disorder
  • Suicidality or parasuicidality
  • Ongoing family violence
  • Alcohol or drug dependence within previous 3 months
  • Enrolled in cognitive-behavioral/exposure-based therapy during study period.
  • Supportive therapy and psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable.
  • An uncontrolled medical condition

Exclusion Criteria for the fMRI only:

  • Foreign metallic objects or implanted devices in the body incompatible with MRI
  • Positive pregnancy test as determined by serum ß-HCG level
  • Claustrophobia
  • CNS neoplasms or neurological conditions such as Parkinson's Disease, Huntington's Chorea, demyelinating diseases, seizures, hydrocephalus, etc.
Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374738
NC181BO-1 (IRB #01012), DUHS Protocol No. 5023-05-10R2
No
No
Study terminated/inactive.
Samueli Institute for Information Biology
Samueli Institute for Information Biology
  • Duke University
  • Durham VA Medical Center
Principal Investigator: Jennifer L. Strauss, PhD Duke University Medical Center & Durham VA Medical Center
Principal Investigator: Christine Marx, MD, MA Duke University Medical Center & Durham VA Medical Center
Samueli Institute for Information Biology
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP