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

Primary Purpose

Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery for Trauma (GIFT)
Sponsored by
Samueli Institute for Information Biology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders focused on measuring Guided Imagery for Trauma (GIFT), Posttraumatic Stress Disorder (PTSD), Military Sexual Trauma (MST), Military Sexual Trauma - related PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GIFT Intervention

Music Control

Arm Description

Guided Imagery for Trauma (GIFT)

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 7, 2006
Last Updated
May 10, 2016
Sponsor
Samueli Institute for Information Biology
Collaborators
Duke University, Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00374738
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samueli Institute for Information Biology
Collaborators
Duke University, Durham VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders
Keywords
Guided Imagery for Trauma (GIFT), Posttraumatic Stress Disorder (PTSD), Military Sexual Trauma (MST), Military Sexual Trauma - related PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIFT Intervention
Arm Type
Experimental
Arm Description
Guided Imagery for Trauma (GIFT)
Arm Title
Music Control
Arm Type
No Intervention
Arm Description
Relaxing Music Audio control; same music used in guided imagery, with no narrative voice.
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery for Trauma (GIFT)
Intervention Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L. Strauss, PhD
Organizational Affiliation
Duke University Medical Center & Durham VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Marx, MD, MA
Organizational Affiliation
Duke University Medical Center & Durham VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study terminated/inactive.

Learn more about this trial

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

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