We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374738
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Stress Disorders Behavioral: Guided Imagery for Trauma (GIFT)

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
Study Start Date : November 2006
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GIFT Intervention
Guided Imagery for Trauma (GIFT)
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.
No Intervention: Music Control
Relaxing Music Audio control; same music used in guided imagery, with no narrative voice.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374738

United States, North Carolina
Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
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
More Information

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT00374738     History of Changes
Other Study ID Numbers: NC181BO-1 (IRB #01012)
DUHS Protocol No. 5023-05-10R2 ( Other Identifier: Duke University Health System (DUHS) )
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study terminated/inactive.

Keywords provided by Samueli Institute for Information Biology:
Guided Imagery for Trauma (GIFT)
Posttraumatic Stress Disorder (PTSD)
Military Sexual Trauma (MST)
Military Sexual Trauma - related PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs