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

NCT ID: NCT00374738

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-09-30

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.

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.

Conditions

Stress Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GIFT Intervention

Guided Imagery for Trauma (GIFT)

Group Type: EXPERIMENTAL

Guided Imagery for Trauma (GIFT)

Intervention Type: BEHAVIORAL

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.

Music Control

Relaxing Music Audio control; same music used in guided imagery, with no narrative voice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Durham VA Medical Center

FED

Sponsor Role: collaborator

Samueli Institute for Information Biology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L. Strauss, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center & Durham VA Medical Center

Christine Marx, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center & Durham VA Medical Center

Locations

Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUHS Protocol No. 5023-05-10R2

Identifier Type: OTHER

Identifier Source: secondary_id

NC181BO-1 (IRB #01012)

Identifier Type: -

Identifier Source: org_study_id