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

Sponsors and Collaborators:	Duke University National Institutes of Health (NIH) Durham VA Medical Center
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00635635

Purpose

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.

Condition	Intervention
Stress Disorder, Post Traumatic Military Sexual Trauma	Behavioral: Guided Imagery Audio Behavioral: Music Audio

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Guided Imagery for Military Sexual Trauma-Related PTSD

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

PTSD Severity - Clinician Administered PTSD Scale (CAPS) [ Time Frame: Midpoint and Endpoint ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neuroactive Steroid assay [ Time Frame: Endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Guided Imagery Audio	Behavioral: Guided Imagery Audio Guided Imagery Audio listened to 5x per week
2: Active Comparator Music Audio	Behavioral: Music Audio Music only audio to be listened to 5x per week

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635635

Locations

United States, North Carolina
Durham VA Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: Jennifer L Strauss, PhD 919-286-0411 ext 5275 strau009@mc.duke.edu

Sponsors and Collaborators

Duke University

National Institutes of Health (NIH)

Durham VA Medical Center

Investigators

Principal Investigator:

Jennifer L Strauss, PhD

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Jennifer L. Strauss, PhD )
Study ID Numbers:	Pro00001282
Study First Received:	March 9, 2008
Last Updated:	March 15, 2009
ClinicalTrials.gov Identifier:	NCT00635635 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Stress Disorders, Post-Traumatic
Anxiety,
Depression,
Guided Imagery
Military Sexual Trauma

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Disorders of Environmental Origin

Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Wounds and Injuries

Disorders of Environmental Origin
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on September 10, 2009