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

This study has been completed.
Sponsor:
Collaborators:
Durham VA Medical Center
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00635635
First received: March 9, 2008
Last updated: May 25, 2010
Last verified: May 2010
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Guided Imagery for Military Sexual Trauma-Related PTSD

Resource links provided by NLM:


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 ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Guided Imagery Audio
Behavioral: Guided Imagery Audio
Guided Imagery Audio listened to 5x per week
Active Comparator: 2
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Durham VA Medical Center
Investigators
Principal Investigator: Jennifer L Strauss, PhD Duke University
  More Information

No publications provided

Responsible Party: Jennifer L. Strauss, PhD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00635635     History of Changes
Other Study ID Numbers: Pro00001282
Study First Received: March 9, 2008
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Stress Disorders, Post-Traumatic
Anxiety,
Depression,
Guided Imagery
Military Sexual Trauma

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Wounds and Injuries
Disease
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014