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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

Collaborators and Investigators

• Sponsor: Samueli Institute for Information Biology
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 7, 2006
• First Submitted That Met QC Criteria: September 7, 2006
• First Posted (Estimate): September 11, 2006

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Posttraumatic Stress Disorder (PTSD); Guided Imagery for Trauma (GIFT); Military Sexual Trauma (MST); Military Sexual Trauma - related PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Sexual Trauma
• Other Study ID Numbers: NC181BO-1 (IRB #01012); DUHS Protocol No. 5023-05-10R2 (Other Identifier: Duke University Health System (DUHS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study terminated/inactive.