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Guided Imagery for Military Sexual Trauma-Related Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Stress Disorder, Post Traumatic, Military Sexual Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery Audio
Music Audio
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress Disorder, Post Traumatic focused on measuring Stress Disorders, Post-Traumatic, Anxiety,, Depression,, Guided Imagery, Military Sexual Trauma

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18-65
  2. Status as a women veteran
  3. Receives care at the Durham VAMC
  4. History of MST, confirmed by CAPS interview
  5. DSM-IV diagnosis of PTSD, confirmed by CAPS interview
  6. Able to participate in a research interview in English.
  7. Regular telephone access

Exclusion Criteria:

  1. Current diagnosis of organic, psychotic, or bipolar disorder
  2. Suicidality or parasuicidality
  3. Ongoing family violence
  4. Alcohol or drug abuse within previous 3 months
  5. Enrolled in cognitive-behavioral/exposure-based therapy for PTSD during study period. Supportive therapy and some psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable. Although patients may use medications, no new medications will be started during the study. This includes, but is not restricted to, SSRIs, benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, non-benzodiazepine hypnotics, stimulants, or antipsychotics.

Sites / Locations

  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Guided Imagery Audio

Music Audio

Outcomes

Primary Outcome Measures

PTSD Severity - Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Neuroactive Steroid assay

Full Information

First Posted
March 9, 2008
Last Updated
May 25, 2010
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00635635
Brief Title
Guided Imagery for Military Sexual Trauma-Related Posttraumatic Stress Disorder (PTSD)
Official Title
Guided Imagery for Military Sexual Trauma-Related PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), Durham VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Military sexual trauma (MST) is a significant women's mental health issue. There is a crucial need for effective therapies for MST-related posttraumatic stress disorder (PTSD) that are well-tolerated and can be flexibly administered in a variety of treatment settings. Guided imagery is a novel, transportable intervention technique that meets these requirements and warrants research in PTSD. The proposed study will be a randomized controlled trial of the Guided Imagery for Trauma (GIFT) intervention for women veterans with MST-related PTSD. This minimal contact intervention is designed to increase coping, affect management and relaxation skills, and to fostering more positive images and beliefs associated with surviving trauma. The feasibility and tolerability of GIFT have already been demonstrated in an open-label pilot of 15 women veterans with MST-related PTSD, with very promising initial results.
Detailed Description
Study Aims: The primary aims of this study are: (1) To determine the efficacy of the GIFT intervention for women veterans with MST-related PTSD. (2) To determine the effects of GIFT on mental health and health services utilization, and neurobiological outcomes. (3) To identify predictors of GIFT treatment outcomes. Research Plan: We will conduct a 12-week randomized, controlled trial of GIFT in 38 women veterans with MST-related PTSD. Half will be randomly assigned to GIFT and half to a music control group. GIFT includes a pretreatment orientation and midpoint consultation session with a clinician facilitator, a guided imagery audio, daily self-monitoring of audio use, and weekly telephone coaching calls with the facilitator. The music control condition is designed to control for all nonspecific aspects of GIFT and matches the GIFT protocol in all ways but the two specific "ingredients" through which GIFT is hypothesized to have its effect: (1) the guided imagery audio, and (2) the facilitator's help in structuring and focusing use of the guided imagery audio. Thus, the key differences between the two groups are that controls will receive an audio of the relaxing background music used on the guided imagery audio, but not the guided imagery exercises, and controls' contacts with the facilitator is limited to psychoeducational information and general support, and will not include help in structuring and focusing use of the audio, which is a key component of GIFT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder, Post Traumatic, Military Sexual Trauma
Keywords
Stress Disorders, Post-Traumatic, Anxiety,, Depression,, Guided Imagery, Military Sexual Trauma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Guided Imagery Audio
Arm Title
2
Arm Type
Active Comparator
Arm Description
Music Audio
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery Audio
Intervention Description
Guided Imagery Audio listened to 5x per week
Intervention Type
Behavioral
Intervention Name(s)
Music Audio
Intervention Description
Music only audio to be listened to 5x per week
Primary Outcome Measure Information:
Title
PTSD Severity - Clinician Administered PTSD Scale (CAPS)
Time Frame
Midpoint and Endpoint
Secondary Outcome Measure Information:
Title
Neuroactive Steroid assay
Time Frame
Endpoint

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: Age 18-65 Status as a women veteran Receives care at the Durham VAMC History of MST, confirmed by CAPS interview 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, psychotic, or bipolar disorder Suicidality or parasuicidality Ongoing family violence Alcohol or drug abuse within previous 3 months Enrolled in cognitive-behavioral/exposure-based therapy for PTSD during study period. Supportive therapy and some psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable. Although patients may use medications, no new medications will be started during the study. This includes, but is not restricted to, SSRIs, benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, non-benzodiazepine hypnotics, stimulants, or antipsychotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Strauss, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Guided Imagery for Military Sexual Trauma-Related Posttraumatic Stress Disorder (PTSD)

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