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Completed

NCT Number: NCT00635635

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Imagery Audio

Behavioral

Guided Imagery Audio listened to 5x per week

Music Audio

Behavioral

Music only audio to be listened to 5x per week

Primary outcomes

  1. PTSD Severity - Clinician Administered PTSD Scale (CAPS)

    Time frame: Midpoint and Endpoint

Secondary outcomes

  1. Neuroactive Steroid assay

    Time frame: Endpoint

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Durham VA Medical Center
  • National Institutes of Health (NIH)

Registry information

Official study title

Guided Imagery for Military Sexual Trauma-Related PTSD

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 14, 2008
Registry last updated
May 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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