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

Study Overview
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Brief Summary
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Our specific aims are: To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans To examine the effects of GIFT on fronto-limbic brain function and To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.

Detailed Description
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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.

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

Conditions
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Stress Disorders

Intervention / Treatment
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* Behavioral: Guided Imagery for Trauma (GIFT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIFT Intervention<br>Guided Imagery for Trauma (GIFT) | Behavioral: Guided Imagery for Trauma (GIFT)<br>* 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.<br>|
| No Intervention: Music Control<br>Relaxing Music Audio control; same music used in guided imagery, with no narrative voice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Imagery for Trauma (GIFT), Posttraumatic Stress Disorder (PTSD), Military Sexual Trauma (MST), Military Sexual Trauma - related PTSD