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

Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374738
• Other study ID #: NC181BO-1 (IRB #01012)
• Secondary ID: DUHS Protocol No
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: February 27, 2009
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: Samueli Institute for Information Biology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Guided Imagery for Trauma (GIFT)

Locations

Country	Name	City	State
United States	Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology	Duke University, Durham VA Medical Center

Country where clinical trial is conducted

United States,