Clinical trial NCT00374738: Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
Official title: Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders
Keywords: Guided Imagery for Trauma (GIFT)
Posttraumatic Stress Disorder (PTSD)
Military Sexual Trauma (MST)
Military Sexual Trauma - related PTSD
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
Collaborators: name: Duke University
name: Durham VA Medical Center
First posted: 2006-09-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)
state: North Carolina
Study officials:
affiliation: Duke University Medical Center & Durham VA Medical Center
name: Jennifer L. Strauss, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center & Durham VA Medical Center
name: Christine Marx, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: