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
  Purpose

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 Intervention
Stress Disorders
Behavioral: Guided Imagery for Trauma (GIFT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function

Resource links provided by NLM:


Further study details as provided by Samueli Institute for Information Biology:

Enrollment: 34
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374738

Locations
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
Investigators
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 
Study First Received: September 7, 2006
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 21, 2016